Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT00372593
Status:
COMPLETED
Last Update Posted:
2021-03-24
First Post:
2006-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015471', 'term': 'Leukemia, Basophilic, Acute'}, {'id': 'D015472', 'term': 'Leukemia, Eosinophilic, Acute'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}, {'id': 'D007947', 'term': 'Leukemia, Megakaryoblastic, Acute'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'C061400', 'term': 'etoposide phosphate'}, {'id': 'D000079982', 'term': 'Gemtuzumab'}, {'id': 'D008942', 'term': 'Mitoxantrone'}], 'ancestors': [{'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D000080084', 'term': 'Calicheamicins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011809', 'term': 'Quinones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain prior Sponsor approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.', 'otherNumAtRisk': 511, 'otherNumAffected': 482, 'seriousNumAtRisk': 511, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.', 'otherNumAtRisk': 511, 'otherNumAffected': 479, 'seriousNumAtRisk': 511, 'seriousNumAffected': 32}, {'id': 'EG002', 'title': 'Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abducens nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Endocrine disorders'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 103}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Anal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Anorectal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 165}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Arachnoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Avascular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Blood and lymphatic system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Bone infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchopulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Buttock pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Capillary leak syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 95}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac troponin T increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Colonic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Colonic hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye 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'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Electrocardiogram QT corrected interval prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Infections and infestations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Investigations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Nervous system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pleural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Portal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Restrictive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Right ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Serum amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Sudden death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Treatment related secondary malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Vascular disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 511, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 511, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-free Survival at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG001', 'title': 'Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG002', 'title': 'Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000', 'lowerLimit': '42.5', 'upperLimit': '51.3'}, {'value': '53.1', 'groupId': 'OG001', 'lowerLimit': '48.6', 'upperLimit': '57.4'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '11.1', 'upperLimit': '80.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from study entry to time of induction failure, relapse, or death, assessed at 3 years', 'description': 'The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt\\^2 (truncated at 3 standard deviations) and 2.5% type I error.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.'}, {'type': 'PRIMARY', 'title': 'Overall Survival at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG001', 'title': 'Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG002', 'title': 'Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'groupId': 'OG000', 'lowerLimit': '61.0', 'upperLimit': '69.4'}, {'value': '69.4', 'groupId': 'OG001', 'lowerLimit': '65.1', 'upperLimit': '73.3'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '11.1', 'upperLimit': '80.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from study entry, assessed at 3 years', 'description': 'The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt\\^2 (truncated at 3 standard deviations) and 2.5% type I error.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Ineligible patients are excluded from analyses of Overall Survival and Event Free Survival.'}, {'type': 'SECONDARY', 'title': 'Remission Induction Rate After 2 Courses of Induction Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}, {'value': '486', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG001', 'title': 'Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG002', 'title': 'Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.851324', 'groupId': 'OG000'}, {'value': '0.882716', 'groupId': 'OG001'}, {'value': '0.666667', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 2 courses of induction (I and II) therapy, assessed for up to 10 years', 'description': 'Patients without an evaluable bone marrow at the end of Induction I will be excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable. The following patients will be considered to not be in complete remission (CR) after 2 courses of therapy: (1) patients who die during Induction I and II; (2) patients with ≥ 5% blasts or extramedullary disease at the end of Induction II.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ineligible (n=42) patients are excluded. Patients without an evaluable bone marrow at the end of Induction I or at the end of Induction II are excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable (n=45).'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival (DFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG001', 'title': 'Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG002', 'title': 'Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000', 'lowerLimit': '51.3', 'upperLimit': '61.5'}, {'value': '63.0', 'groupId': 'OG001', 'lowerLimit': '58.0', 'upperLimit': '67.5'}, {'value': '75.0', 'groupId': 'OG002', 'lowerLimit': '12.8', 'upperLimit': '96.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 years from end of Intensification I', 'description': 'Time from end of Intensification I to relapse, death or last contact', 'unitOfMeasure': 'Percentage participants DFS at 3 years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Ineligible (n=42) patients are excluded. Patients who did not continue on therapy at end of Intensification I are also excluded (n=247).'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG001', 'title': 'Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG002', 'title': 'Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the first three courses of therapy', 'description': 'Number of participants who died during the first three courses of therapy.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ineligible (n=42) patients are excluded.'}, {'type': 'SECONDARY', 'title': 'Time to Marrow Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG001', 'title': 'Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG002', 'title': 'Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}], 'classes': [{'title': 'During Induction I (days 0 - 28 of therapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.56', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '30.56', 'spread': '6.47', 'groupId': 'OG001'}, {'value': '29.17', 'spread': '2.79', 'groupId': 'OG002'}]}]}, {'title': 'During Induction II (days 29 - 56 of therapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '405', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.54', 'spread': '6.69', 'groupId': 'OG000'}, {'value': '28.52', 'spread': '6.25', 'groupId': 'OG001'}, {'value': '26.6', 'spread': '4.83', 'groupId': 'OG002'}]}]}, {'title': 'During Intensification I (days 57 - 84 of therapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '383', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.51', 'spread': '5.95', 'groupId': 'OG000'}, {'value': '28.10', 'spread': '6.32', 'groupId': 'OG001'}, {'value': '24.5', 'spread': '3.70', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 25 days after treatment with Induction I, Induction II, and Intensification I', 'description': 'Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days.', 'unitOfMeasure': 'Mean days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Excluded: Ineligible patients (pts) (n=42) for overall number of pts analyzed. For Induction I: Pts who did not have ANC recovery (n=237) or w/unknown (w/unk) status (n=14). For Induction II: Pts who did not have ANC recovery (n=142) or w/unk status (n=82). For Intensification I: Pts who did not have ANC recovery (n=104) or w/unk status (n=182)'}, {'type': 'SECONDARY', 'title': 'Toxicities, Including Infectious Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '511', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG001', 'title': 'Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'OG002', 'title': 'Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}], 'classes': [{'categories': [{'measurements': [{'value': '482', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time therapy is initiated, assessed up to 10 years', 'description': 'Number of participants with at least one grade 3 or higher adverse event during therapy.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Ineligible (n=42) patients are excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'FG001', 'title': 'Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'FG002', 'title': 'Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '531'}, {'groupId': 'FG001', 'numSubjects': '532'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '327'}, {'groupId': 'FG001', 'numSubjects': '334'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '198'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'BG000'}, {'value': '532', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '1070', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'BG001', 'title': 'Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome', 'description': 'Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'BG002', 'title': 'Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3352.86', 'spread': '2336.55', 'groupId': 'BG000'}, {'value': '3466', 'spread': '2283.45', 'groupId': 'BG001'}, {'value': '4206.71', 'spread': '1979.95', 'groupId': 'BG002'}, {'value': '3409.43', 'spread': '2310', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '516', 'groupId': 'BG000'}, {'value': '510', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '1033', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '260', 'groupId': 'BG000'}, {'value': '277', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '541', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '529', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '383', 'groupId': 'BG000'}, {'value': '394', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '782', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '197', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '411', 'groupId': 'BG000'}, {'value': '416', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '834', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '473', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '958', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1070}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2006-09-06', 'resultsFirstSubmitDate': '2015-01-06', 'studyFirstSubmitQcDate': '2006-09-06', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-06', 'studyFirstPostDateStruct': {'date': '2006-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free Survival at 3 Years', 'timeFrame': 'Time from study entry to time of induction failure, relapse, or death, assessed at 3 years', 'description': 'The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt\\^2 (truncated at 3 standard deviations) and 2.5% type I error.'}, {'measure': 'Overall Survival at 3 Years', 'timeFrame': 'Time from study entry, assessed at 3 years', 'description': 'The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt\\^2 (truncated at 3 standard deviations) and 2.5% type I error.'}], 'secondaryOutcomes': [{'measure': 'Remission Induction Rate After 2 Courses of Induction Therapy', 'timeFrame': 'After 2 courses of induction (I and II) therapy, assessed for up to 10 years', 'description': 'Patients without an evaluable bone marrow at the end of Induction I will be excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable. The following patients will be considered to not be in complete remission (CR) after 2 courses of therapy: (1) patients who die during Induction I and II; (2) patients with ≥ 5% blasts or extramedullary disease at the end of Induction II.'}, {'measure': 'Disease-free Survival (DFS)', 'timeFrame': 'At 3 years from end of Intensification I', 'description': 'Time from end of Intensification I to relapse, death or last contact'}, {'measure': 'Mortality', 'timeFrame': 'During the first three courses of therapy', 'description': 'Number of participants who died during the first three courses of therapy.'}, {'measure': 'Time to Marrow Recovery', 'timeFrame': 'At 25 days after treatment with Induction I, Induction II, and Intensification I', 'description': 'Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days.'}, {'measure': 'Toxicities, Including Infectious Complications', 'timeFrame': 'From the time therapy is initiated, assessed up to 10 years', 'description': 'Number of participants with at least one grade 3 or higher adverse event during therapy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adult acute myeloid leukemia with 11q23 (MLL) abnormalities', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)', 'untreated adult acute myeloid leukemia', 'untreated childhood acute myeloid leukemia and other myeloid malignancies', 'adult acute basophilic leukemia', 'adult acute eosinophilic leukemia', 'adult acute minimally differentiated myeloid leukemia (M0)', 'adult acute myeloblastic leukemia without maturation (M1)', 'adult acute myeloblastic leukemia with maturation (M2)', 'adult acute myelomonocytic leukemia (M4)', 'adult acute monoblastic leukemia (M5a)', 'adult acute monocytic leukemia (M5b)', 'adult erythroleukemia (M6a)', 'adult pure erythroid leukemia (M6b)', 'adult acute megakaryoblastic leukemia (M7)', 'childhood acute basophilic leukemia', 'childhood acute eosinophilic leukemia', 'childhood acute minimally differentiated myeloid leukemia (M0)', 'childhood acute myeloblastic leukemia without maturation (M1)', 'childhood acute myeloblastic leukemia with maturation (M2)', 'childhood acute myelomonocytic leukemia (M4)', 'childhood acute monocytic leukemia (M5b)', 'childhood acute monoblastic leukemia (M5a)', 'childhood acute erythroleukemia (M6)', 'childhood acute megakaryocytic leukemia (M7)'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'pmid': '22378848', 'type': 'BACKGROUND', 'citation': 'Pollard JA, Alonzo TA, Loken M, Gerbing RB, Ho PA, Bernstein ID, Raimondi SC, Hirsch B, Franklin J, Walter RB, Gamis A, Meshinchi S. Correlation of CD33 expression level with disease characteristics and response to gemtuzumab ozogamicin containing chemotherapy in childhood AML. Blood. 2012 Apr 19;119(16):3705-11. doi: 10.1182/blood-2011-12-398370. Epub 2012 Feb 29.'}, {'pmid': '25092781', 'type': 'RESULT', 'citation': "Gamis AS, Alonzo TA, Meshinchi S, Sung L, Gerbing RB, Raimondi SC, Hirsch BA, Kahwash SB, Heerema-McKenney A, Winter L, Glick K, Davies SM, Byron P, Smith FO, Aplenc R. Gemtuzumab ozogamicin in children and adolescents with de novo acute myeloid leukemia improves event-free survival by reducing relapse risk: results from the randomized phase III Children's Oncology Group trial AAML0531. J Clin Oncol. 2014 Sep 20;32(27):3021-32. doi: 10.1200/JCO.2014.55.3628."}, {'pmid': '40294366', 'type': 'DERIVED', 'citation': "Huang BJ, Meyer LK, Alonzo TA, Wang YC, Lamble AJ, Ries RE, Wang W, Hirsch B, Raca G, Ma X, Gamis AS, Aplenc R, Kolb EA, Cooper TM, Tarlock K, Loken MR, Meshinchi S, Chewning JH, Woods WG, Horan JT. Hematopoietic Stem Cell Transplantation Outcomes for High-Risk AML: A Report From the Children's Oncology Group. J Clin Oncol. 2025 Jun 10;43(17):1961-1971. doi: 10.1200/JCO-24-01841. Epub 2025 Apr 28."}, {'pmid': '38295280', 'type': 'DERIVED', 'citation': 'Tarlock K, Gerbing RB, Ries RE, Smith JL, Leonti A, Huang BJ, Kirkey D, Robinson L, Peplinski JH, Lange B, Cooper TM, Gamis AS, Kolb EA, Aplenc R, Pollard JA, Alonzo TA, Meshinchi S. Prognostic impact of cooccurring mutations in FLT3-ITD pediatric acute myeloid leukemia. Blood Adv. 2024 May 14;8(9):2094-2103. doi: 10.1182/bloodadvances.2023011980.'}, {'pmid': '37267439', 'type': 'DERIVED', 'citation': "Zarnegar-Lumley S, Alonzo TA, Gerbing RB, Othus M, Sun Z, Ries RE, Wang J, Leonti A, Kutny MA, Ostronoff F, Radich JP, Appelbaum FR, Pogosova-Agadjanyan EL, O'Dwyer K, Tallman MS, Litzow M, Atallah E, Cooper TM, Aplenc RA, Abdel-Wahab O, Gamis AS, Luger S, Erba H, Levine R, Kolb EA, Stirewalt DL, Meshinchi S, Tarlock K. Characteristics and prognostic impact of IDH mutations in AML: a COG, SWOG, and ECOG analysis. Blood Adv. 2023 Oct 10;7(19):5941-5953. doi: 10.1182/bloodadvances.2022008282."}, {'pmid': '36815378', 'type': 'DERIVED', 'citation': 'Bertrums EJM, Smith JL, Harmon L, Ries RE, Wang YJ, Alonzo TA, Menssen AJ, Chisholm KM, Leonti AR, Tarlock K, Ostronoff F, Pogosova-Agadjanyan EL, Kaspers GJL, Hasle H, Dworzak M, Walter C, Muhlegger N, Morerio C, Pardo L, Hirsch B, Raimondi S, Cooper TM, Aplenc R, Gamis AS, Kolb EA, Farrar JE, Stirewalt D, Ma X, Shaw TI, Furlan SN, Brodersen LE, Loken MR, Van den Heuvel-Eibrink MM, Zwaan CM, Triche TJ, Goemans BF, Meshinchi S. Comprehensive molecular and clinical characterization of NUP98 fusions in pediatric acute myeloid leukemia. Haematologica. 2023 Aug 1;108(8):2044-2058. doi: 10.3324/haematol.2022.281653.'}, {'pmid': '34596937', 'type': 'DERIVED', 'citation': "Elgarten CW, Wood AC, Li Y, Alonzo TA, Brodersen LE, Gerbing RB, Getz KD, Huang YV, Loken M, Meshinchi S, Pollard JA, Sung L, Woods WG, Kolb EA, Gamis AS, Aplenc R. Outcomes of intensification of induction chemotherapy for children with high-risk acute myeloid leukemia: A report from the Children's Oncology Group. Pediatr Blood Cancer. 2021 Dec;68(12):e29281. doi: 10.1002/pbc.29281. Epub 2021 Oct 1."}, {'pmid': '33080007', 'type': 'DERIVED', 'citation': "Brodersen LE, Gerbing RB, Pardo ML, Alonzo TA, Paine D, Fritschle W, Hsu FC, Pollard JA, Aplenc R, Kahwash SB, Hirsch B, Ramondi S, Wells D, Kolb EA, Gamis AS, Meshinchi S, Loken MR. Morphologic remission status is limited compared to DeltaN flow cytometry: a Children's Oncology Group AAML0531 report. Blood Adv. 2020 Oct 27;4(20):5050-5061. doi: 10.1182/bloodadvances.2020002070."}, {'pmid': '28883080', 'type': 'DERIVED', 'citation': "Voigt AP, Brodersen LE, Alonzo TA, Gerbing RB, Menssen AJ, Wilson ER, Kahwash S, Raimondi SC, Hirsch BA, Gamis AS, Meshinchi S, Wells DA, Loken MR. Phenotype in combination with genotype improves outcome prediction in acute myeloid leukemia: a report from Children's Oncology Group protocol AAML0531. Haematologica. 2017 Dec;102(12):2058-2068. doi: 10.3324/haematol.2017.169029. Epub 2017 Sep 7."}, {'pmid': '27133823', 'type': 'DERIVED', 'citation': "Eidenschink Brodersen L, Alonzo TA, Menssen AJ, Gerbing RB, Pardo L, Voigt AP, Kahwash SB, Hirsch B, Raimondi S, Gamis AS, Meshinchi S, Loken MR. A recurrent immunophenotype at diagnosis independently identifies high-risk pediatric acute myeloid leukemia: a report from Children's Oncology Group. Leukemia. 2016 Oct;30(10):2077-2080. doi: 10.1038/leu.2016.119. Epub 2016 May 2. No abstract available."}, {'pmid': '23471307', 'type': 'DERIVED', 'citation': "Sung L, Aplenc R, Alonzo TA, Gerbing RB, Lehrnbecher T, Gamis AS. Effectiveness of supportive care measures to reduce infections in pediatric AML: a report from the Children's Oncology Group. Blood. 2013 May 2;121(18):3573-7. doi: 10.1182/blood-2013-01-476614. Epub 2013 Mar 7."}], 'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid leukemia.\n\nPURPOSE: This randomized phase III trial is studying combination chemotherapy and gemtuzumab to see how well they work compared with combination chemotherapy alone in treating young patients with newly diagnosed acute myeloid leukemia.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the event-free survival (EFS) and overall survival (OS) of young patients with newly diagnosed acute myeloid leukemia (AML) treated with conventional combination chemotherapy with vs without gemtuzumab ozogamicin (GMTZ).\n\nSecondary\n\n* Compare the remission induction rates after two courses of therapy in these patients.\n* Compare disease-free survival and OS in patients who are eligible for an human leukocyte antigen (HLA)-matched family donor (MFD) stem cell transplant (SCT) by virtue of their risk classification, with patients assigned to MFD SCT if a MFD is available, or to chemotherapy if a MFD is not available.\n* Determine the outcome of patients with Down syndrome who are 4 years of age or older at diagnosis and treated with conventional combination chemotherapy without GMTZ.\n* Compare the EFS and OS of patients with de novo AML treated with conventional combination chemotherapy with vs without GMTZ censoring MFD SCT recipients.\n* Determine the prevalence and prognostic significance of molecular abnormalities of KIT, CCAAT-enhancer binding protein alpha (CEBPα) and MLL-Partial tandem duplications (PTD) genes in these patients.\n* Determine the leukemic involvement of hematopoietic early progenitor and its role in defining response to therapy.\n* Assess the ability of a second-generation flow cytometric assay to predict patients at high risk for relapse during periods of clinical remission.\n* Examine whether GMTZ significantly improves EFS and OS in patients with higher CD33 concentrations/intensity.\n* Examine whether GMTZ significantly improves complete remission, EFS, and OS in each of the cytogenetic risk groups (high-, intermediate-, and low-risk) identified in prior Medical Research Council trials.\n* Utilize fluorescence in situ hybridization (FISH) analysis to identify variant patterns among subgroups of patients who demonstrate the same G-banded chromosomal abnormality (e.g., inv\\[16\\]/t\\[16;16\\], t\\[8;21\\], 11q23 abnormality) and determine whether these variant patterns account for the heterogeneity of responses to therapy.\n* Examine the impact of complex karyotypes (≥ 3, ≥ 4, and ≥ 5 abnormalities) on OS and EFS in intermediate-risk patients for whom no high-risk or low-risk cytogenetic abnormalities exist.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to relapse risk (high vs intermediate vs low). Patients are randomized to 1 of 2 treatment arms. Patients with Down syndrome are nonrandomly assigned to arm I (but do not undergo allogeneic stem cell transplant \\[SCT\\]).\n\n* Arm I (standard therapy):\n\n * Induction 1: Patients receive cytarabine IT at the time of diagnosis or on day 1\\*. Patients also receive cytarabine IV on days 1-10, daunorubicin hydrochloride IV over 6 hours on days 1, 3, and 5, and etoposide IV over 4 hours on days 1-5. After 3 weeks of rest, all patients (regardless of remission status) proceed to induction 2.\n\nNOTE: \\*Patients with Central Nervous System (CNS) disease receive cytarabine IT twice weekly until the cerebrospinal fluid is clear, followed by two additional IT treatments. Patients with refractory CNS leukemia after 6 doses of IT treatment are removed from the study.\n\n* Induction 2: Patients receive cytarabine IT on day 1, cytarabine IV on days 1-8, daunorubicin hydrochloride IV over 6 hours on days 1, 3, and 5, and etoposide IV over 4 hours on days 1-5. After 3 weeks of rest, patients in complete remission (CR) proceed to intensification 1. Patients with refractory disease are removed from protocol therapy.\n* Intensification 1: Patients receive cytarabine IT on day 1, high-dose cytarabine IV over 1 hour on days 1-5, and etoposide IV over 1 hour on days 1-5. After 3 weeks of rest, patients in remission proceed to intensification 2, followed by intensification 3. Patients in remission proceed to allogeneic SCT 2-8 weeks after blood counts recover. Patients with high-risk disease with an alternative donor proceed to intensification 2 and 3, followed by allogeneic SCT. Patients not in remission are removed from protocol therapy.\n* Intensification 2: Patients receive cytarabine IT on day 1, high-dose cytarabine IV over 2 hours on days 1-4, and mitoxantrone hydrochloride IV over 1 hour on days 3-6. After 3 weeks of rest, patients proceed to intensification 3.\n* Intensification 3: Patients receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, and 9 and asparaginase intramuscularly on days 2 and 9.\n\n * Arm II:\n* Induction 1: Patients receive treatment as in induction 1 of arm I. Patients also receive gemtuzumab ozogamicin (GMTZ) IV over 2 hours on day 6.\n* Induction 2: Patients receive treatment as in induction 2 of arm I.\n* Intensification 1: Patients receive treatment as in intensification 1 of arm I.\n* Intensification 2: Patients receive treatment as in intensification 2 of arm I. Patients also receive GMTZ IV over 2 hours on day 7.\n* Intensification 3: Patients receive treatment as in intensification 3 of arm I.\n\n * Allogeneic SCT (for patients with intermediate- or high-risk disease):\n* MFD: Patients receive a conditioning regimen comprising busulfan IV over 2 hours every 6 hours on days -9 to -6 and cyclophosphamide IV over 1 hour on days -5 to -2. Patients undergo allogeneic SCT on day 0. Patients receive cyclosporine IV or orally twice daily on days -1 to 180 and methotrexate IV on days 1, 3, 6, and 11. Patients receive graft-vs-host disease (GVHD) prophylaxis comprising cyclosporine IV over 1-4 hours or orally twice daily on days -1 to 180 and methotrexate IV on days 1, 3, 6, and 11.\n* Matched alternative donor: Patients receive a conditioning regimen comprising busulfan and cyclophosphamide as above. Patients also receive antithymocyte globulin IV over 6-8 hours on days -3 to -1. Patients then undergo allogeneic SCT and receive GVHD prophylaxis as above.\n\nAfter completion of study treatment, patients are followed periodically for 3 years and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 1,012 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Newly diagnosed acute myeloid leukemia (AML)\n\n * Meets customary criteria for AML with ≥ 20% bone marrow blasts (by WHO classification)\n\n * Patients with \\< 20% bone marrow blasts and cytopenia or myelodysplastic syndromes (e.g., chronic myelomonocytic leukemia, refractory anemia (RA), RA with excess blasts, RA with ringed sideroblasts) are eligible provided 1 of the following criteria is met:\n\n * Karyotypic abnormality characteristic of de novo AML (t\\[8;21\\]\\[q22;q22\\], inv\\[16\\]\\[p13q22\\], t\\[16;16\\]\\[p13;q22\\], or 11q23 abnormalities)\n * Unequivocal presence of megakaryoblasts (by WHO classification)\n * Isolated myeloid sarcoma (i.e., myeloblastoma or chloroma) allowed regardless of bone marrow results\n* Infants \\< 1 month of age with progressive disease\\* are eligible NOTE: \\*Infants \\< 1 month of age with AML may be given supportive care until it is clear that the leukemia is not regressing (i.e., the disappearance of peripheral blasts and the normalization of peripheral blood counts)\n* Patients with Down syndrome ≥ 4 years of age are eligible\n* No juvenile myelomonocytic leukemia\n* No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome\n* No promyelocytic leukemia (M3)\n* No secondary or treatment-related AML\n* Matched family donor criteria (for patients with intermediate-risk or high-risk disease):\n\n * HLA-A, -B, -C, and beta chain (-DRB1), identical or 1 antigen or allele mismatched by molecular high resolution technique\n * All available first-degree family members (parents and siblings) must be HLA typed\n * No syngeneic donors\n* Matched alternative donor criteria (for patients with high-risk disease):\n\n * HLA-A, -B, -C, and -DRB1, identical or 1 antigen or allele mismatched donor\n * HLA-A, -B, and -DRB1 4 of 6 antigen matched unrelated cord blood donor\n * Mismatched family member donor with ≥ 1 haplotype match or 5 of 6 antigen phenotypic match\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy, radiation therapy, or any antileukemic therapy\n\n * Topical or inhalation steroids for other conditions allowed\n * Intrathecal cytarabine given at diagnosis allowed\n* No other prior treatment for AML\n* No concurrent peripheral blood stem cell transplantation in patients with matched family donor"}, 'identificationModule': {'nctId': 'NCT00372593', 'briefTitle': 'Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults', 'orgStudyIdInfo': {'id': 'AAML0531'}, 'secondaryIdInfos': [{'id': 'COG-AAML0531', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'CDR0000487497', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'NCI-2009-00320', 'type': 'REGISTRY', 'domain': 'Clinical Trials Reporting Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5.\n\nAfter 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5.\n\nAfter 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5.\n\nAfter 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.', 'interventionNames': ['Drug: asparaginase', 'Drug: cytarabine', 'Drug: daunorubicin hydrochloride', 'Drug: etoposide', 'Drug: mitoxantrone hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome', 'description': 'Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \\& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.', 'interventionNames': ['Drug: asparaginase', 'Drug: cytarabine', 'Drug: daunorubicin hydrochloride', 'Drug: etoposide', 'Drug: gemtuzumab ozogamicin', 'Drug: mitoxantrone hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome', 'description': 'Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5.\n\nAfter 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5.\n\nAfter 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5.\n\nAfter 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.', 'interventionNames': ['Drug: asparaginase', 'Drug: cytarabine', 'Drug: daunorubicin hydrochloride', 'Drug: etoposide', 'Drug: mitoxantrone hydrochloride']}], 'interventions': [{'name': 'asparaginase', 'type': 'DRUG', 'otherNames': ['E.coli', 'E.coli L-asparaginase', 'EC 3.5.2.2', 'colaspase', 'L-asnase', 'Elspar', 'Kidrolase', 'Crasnitin', 'Leunase', 'NSC 109229'], 'description': 'Given intramuscularly', 'armGroupLabels': ['Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome', 'Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome', 'Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome']}, {'name': 'cytarabine', 'type': 'DRUG', 'otherNames': ['Cytosine arabinoside', 'Ara-C', 'Cytosar', 'NSC # 63878'], 'description': 'Given IV', 'armGroupLabels': ['Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome', 'Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome', 'Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome']}, {'name': 'daunorubicin hydrochloride', 'type': 'DRUG', 'otherNames': ['Daunomycin', 'rubidomycin', 'Cerubidine', 'NSC #82151'], 'description': 'Given IV over 6 hours', 'armGroupLabels': ['Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome', 'Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome', 'Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome']}, {'name': 'etoposide', 'type': 'DRUG', 'otherNames': ['VePesid', 'Etopophos', 'VP-16', 'NSC #141540'], 'description': 'Given IV over 1-4 hours', 'armGroupLabels': ['Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome', 'Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome', 'Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome']}, {'name': 'gemtuzumab ozogamicin', 'type': 'DRUG', 'otherNames': ['Mylotarg', 'GMTZ'], 'description': 'Given IV over 2 hours', 'armGroupLabels': ['Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome']}, {'name': 'mitoxantrone hydrochloride', 'type': 'DRUG', 'otherNames': ['Novantrone', 'CL 232315', 'DAD', 'DHAD', 'Mitozantrone', 'NSC #301739'], 'description': 'Given IV over 1 hour', 'armGroupLabels': ['Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome', 'Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome', 'Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85202', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Desert Medical Center', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724-5024', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research Center at University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Cancer Institute at Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048-1865', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93636-8762', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Central California", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital and Research Center Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center - Oakland', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92868-3874', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92123-4282', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital - San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '93105', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': "Santa Barbara Cottage Children's Hospital", 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': "Jonathan Jaques Children's Cancer Center at Miller Children's Hospital", 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Center for Cancer and Blood Disorders", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06360-2875', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06520-8028', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20010-2970', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20307-5001', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward General Medical Center Cancer Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee Cancer Care of Lee Memorial Health System', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32610-0232', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Shands Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Cancer Institute at Memorial Regional Hospital', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32207-8426', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Sylvester Comprehensive Cancer Center - Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Miami Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist-South Miami Regional Cancer Program', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803-1273', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Cancer Institute at Florida Hospital Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center at Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic - Orlando", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Sacred Heart Cancer Center at Sacred Heart Hospital', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Cancer Institute at St. Joseph's Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': "Kaplan Cancer Center at St. Mary's Medical Center", 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - 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