Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT03531918
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2018-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017338', 'term': 'Cladribine'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D000079982', 'term': 'Gemtuzumab'}, {'id': 'C423652', 'term': 'pegylated granulocyte colony-stimulating factor'}, {'id': 'D008942', 'term': 'Mitoxantrone'}], 'ancestors': [{'id': 'D015762', 'term': '2-Chloroadenosine'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003839', 'term': 'Deoxyadenosines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D000080084', 'term': 'Calicheamicins'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': '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': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rwalter@fredhutch.org', 'phone': '206-667-3599', 'title': 'Roland Walter, Member of Clinical Research Division', 'organization': 'Fred Hutchinson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This is a single center study and generalizability to other centers is unclear. This is a non-randomized, single arm study without a contemporaneously enrolled control arm. The number of participants at the phase 1 dose level GO1 was insufficient to perform statistically reliable analyses.'}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events and other (not including serious) adverse events were monitored and recorded for only the first cycle of therapy (the only period of experimental therapy). Patients were monitored from the start of the first drug administration (on day 0 or day 1) until the start of the second cycle of therapy, or until 1 month post the first response assessment. All-Cause Mortality was assessed for 3 years and 1 month.', 'description': 'Adverse events were collected systematically through regular investigator and study staff assessment in combination with reviews of clinical, laboratory, and imaging records and ongoing direct communication with treating physicians and sub-investigators. Only adverse events rated grade 3 or higher, with the exception of all hematologic toxicities, are recorded, graded, and reported. Grading drawn from CTCAE version 5.0.', 'eventGroups': [{'id': 'EG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 59, 'seriousNumAtRisk': 60, 'deathsNumAffected': 2, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Grade 3 Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 88, 'numAffected': 56}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Esophageal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Chest Pain - Cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 4 Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 79, 'numAffected': 37}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Perineal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Vaginal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Alanine Aminotransferase Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 4 Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Tumor Lysis Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Upper Gastrointestinal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Lower Gastrointestinal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Disseminated Intravascular Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Intracranial Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Aspartate Aminotransferase Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hepatic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Typhlitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Left Ventricular Systolic Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Ejection Fraction Decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Pulmonary Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 4 Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Mucositis Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 4 Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hyperphosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Generalized Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Catheter Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Rash Maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 4 Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Bronchopulmonary Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Colonic Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Colonic Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Anorectal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'seriousEvents': [{'term': 'Grade 4 Bronchopulmonary Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Left Ventricular Systolic Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 4 Aspartate Aminotransferase Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Reversible Posterior Leukoencephalopathy Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Intercranial Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 4 Tumor Lysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 4 Upper Gastrointestinal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Encephalitis Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 3 Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 4 Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 4 Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Grade 4 Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) of Gemtuzumab Ozogamicin (GO) When Added to GCLAM (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'OG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The Maximum Tolerated Dose was not reached since the GO3 dose level (the maximum dose specified by the protocol) had a dose-limiting toxicity rate of greater than 33%. Thusly, the GO3 dose level is the recommended phase 2 dose but not the MTD.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'The Maximum Tolerated Dose was not reached since the GO3 dose level (the maximum dose specified by the protocol) had a dose-limiting toxicity rate of greater than 33%. Thusly, the GO3 dose level is the recommended phase 2 dose but not the MTD.', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of count recovery, second cycle of treatment, response assessment or removal from protocol (at approximately 1 month).', 'description': 'Defined as the highest dose studied in which the incidence of Dose Limiting Toxicity (DLT) is ≤33% (≤4 of 12 patients experiencing DLT), defined as any Grade 3 non-hematologic toxicity lasting \\>48 hours that results in \\>7-day delay of the subsequent treatment cycle, with the exception of febrile neutropenia or infection or toxicities secondary to febrile neutropenia or infection, or any Grade ≥4 non-hematologic toxicity except febrile neutropenia/infection (or toxicities secondary to febrile neutropenia or infection) unless felt to be a direct consequence of treatment-related toxicity (e.g. intestinal infection following mucosal barrier breakdown), and with the exception of constitutional symptoms if recovery to Grade ≤2 within 14 days. The National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 will be used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Event-free Survival (EFS) Rate (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GO1 Dose Level', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'OG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}], 'classes': [{'title': 'Event-free Survival (6 months)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '85'}]}]}, {'title': 'Event-free survival (12 months)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '72'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of study treatment, assessed at 6 months and 1 year', 'description': 'A two-stage design will be used to evaluate the EFS. Patients treated at the maximum tolerated dose (MTD) from the phase 1 portion of the trial will be used in the phase 2 analysis. If censoring occurs, secondary analyses analyzing 6-month or 1-year EFS accounting for censoring will be done, including estimating 6-month or 1-year EFS using the Kaplan-Meier method. The first stage of the two-stage phase 2 design will evaluate 30 patients. If 20 or more of the first 30 patients are alive without event at 6-months after study registration, an additional 30 patients will be enrolled. If 46 or more of the 60 patients treated at the MTD are alive and without event at 6-months after study registration, the study will consider the regimen of interest for further investigation. Patients last known to be alive in CR were censored at date of last contact.', 'unitOfMeasure': 'percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'GO1 participants were treated in dose escalation. The primary endpoint per protocol is to assess the EFS rate at the MTD or RP2D and was not assessed at dose levels below the RP2D.'}, {'type': 'SECONDARY', 'title': '30-day All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'OG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '.03', 'groupId': 'OG001', 'lowerLimit': '.0004', 'upperLimit': '.12'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years. 30-day all-cause mortality is reported', 'description': 'As a summary of adverse events (captured on trial using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0), 30-day all cause mortality is reported as a percent of patients treated at the MTD/RP2D.\n\nWill be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.', 'unitOfMeasure': 'proportion died on/before day 30', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '30-day mortality is reported among patients treated at the MTD/RP2D. There is no study-related reason to report survival data on the GO1 dose level. No efficacy assessments were evaluated during the GO1 phase 1 dose escalation study which focuses on DLT/toxicity assessments.'}, {'type': 'SECONDARY', 'title': 'Relapse-free Survival of GO3 Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'OG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '64'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years. 2-year RFS reported.', 'description': 'RFS was calculated for participants who achieved a complete remission (with or without count recovery; CR or CRi) and measured from the date remission to the first of relapse from CR/CRi or death from any cause. Patients last known to be alive in CR /CRi were censored at date of last contact. Will be estimated using the Kaplan-Meier method. Time to relapse will be estimated using non-parametric estimates of the cumulative incidence curve with death analyzed as a competing event. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RFS is reported among patients treated at the MTD/RP2D. There is no study-related reason to report survival data on the GO1 dose level. No efficacy assessments were evaluated during the GO 1 phase 1 dose escalation study which focuses on DLT/toxicity assessments.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'OG001', 'title': 'GO3 Dose Level', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG001', 'lowerLimit': '48', 'upperLimit': '73'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years and 1 month', 'description': 'OS was calculated for all participants and measured from initial trial therapy to death from any cause. Patients last known ot be alive were censored at date of last contact. Will be estimated using the Kaplan-Meier method. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RFS is reported among patients treated at the MTD/RP2D. There is no study-related reason to report survival data on the GO1 dose level. No efficacy assessments were evaluated during the GO1 phase 1 dose escalation study which focuses on DLT/toxicity assessments.'}, {'type': 'SECONDARY', 'title': 'Measurable Residual Disease (MRD) Rates and Remission Rates: CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'OG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}], 'classes': [{'title': 'MRDneg', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'MRDpos', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.\n\nComplete response (CR) rate is defined as the frequency of patients achieving CR, which is defined by the European LeukemiaNet 2017 guidelines as bone marrow blasts \\<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 x 109/L (1000/mL); platelet count ≥100 x 109/L. (100 000/mL). MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry.\n\nAplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS.\n\nStatistical significance tests were not performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measurable Residual Disease (MRD) and Remission Rates: CRi (MRDneg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'OG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.\n\nComplete response with incomplete hematologic recovery (CRi) rate is defined as the frequency of patients achieving CRi, which is defined by the European LeukemiaNet 2017 guidelines as all CR criteria except for residual neutropenia (ANC \\<1.0 x 109/L \\[1000/mL\\]) or thrombocytopenia (platelet count \\<100 x 109/L \\[100,000/mL\\]). MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry.\n\nAplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS.\n\nStatistical significance tests were not performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measurable Residual Disease (MRD) and Remission Rates: CR/CRi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'OG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.\n\nComplete response (CR) + complete response with incomplete hematologic recovery (CRi) rate is defined as the frequency of patients achieving CR or CRi per the European LeukemiaNet 2017 criteria as defined above. MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry.\n\nAplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS.\n\nStatistical significance tests were not performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'GO1: remission rates for 6 patients: CR rate was 4/6, CR+CRi rate was 5/6 (all MRDneg)'}, {'type': 'SECONDARY', 'title': 'Measurable Residual Disease (MRD) and Remission Rates: MLFS (MRDneg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'OG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.\n\nMorphologic leukemia free state (MLFS) rate is defined as the frequency of patients achieving MLFS, which is defined by the European LeukemiaNet guidelines as bone marrow blasts \\<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. At least 200 cells should be enumerated or cellularity should be at least 10%. MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry.\n\nAplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS.\n\nStatistical significance', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measurable Residual Disease (MRD) and Remission Rates: Alapasia (MRDneg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'OG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.\n\no Aplasia rate is defined in this protocol as frequency of patients without blood count recovery after chemotherapy and bone marrow examination showing hypocellularity not meeting cellularity criteria for morphologic leukemia free state (MLFS). MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry.\n\nAplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS.\n\nStatistical significance tests were not performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'FG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GO1 Dose Level Phase 1', 'description': 'Participants received 1 dose of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on day 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'BG001', 'title': 'GO3 Dose Level Includes Phase 1 and Phase 2', 'description': 'Phase 1: Participants received 3 doses of gemtuzumab ozogamicin (GO) intravenously at 3 mg/m2 per dose on days 1, 4, and 7.\n\nPhase 2: Participants received CLAG-M(cladribine, high-dose cytarabine, G-CSF and dose-escalated mitoxantrone)/GO at the recommended phase 2 dose (RP2D) identified in phase 1.\n\nAll doses of GO were capped at 4.5 mg.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.83', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '73'}, {'value': '61.13', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '80'}, {'value': '61.47', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-17', 'size': 1255222, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-27T18:46', 'hasProtocol': True}, {'date': '2019-04-10', 'size': 1020292, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-27T18:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2018-05-09', 'resultsFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2018-05-09', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-10', 'studyFirstPostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of Gemtuzumab Ozogamicin (GO) When Added to GCLAM (Phase 1)', 'timeFrame': 'At time of count recovery, second cycle of treatment, response assessment or removal from protocol (at approximately 1 month).', 'description': 'Defined as the highest dose studied in which the incidence of Dose Limiting Toxicity (DLT) is ≤33% (≤4 of 12 patients experiencing DLT), defined as any Grade 3 non-hematologic toxicity lasting \\>48 hours that results in \\>7-day delay of the subsequent treatment cycle, with the exception of febrile neutropenia or infection or toxicities secondary to febrile neutropenia or infection, or any Grade ≥4 non-hematologic toxicity except febrile neutropenia/infection (or toxicities secondary to febrile neutropenia or infection) unless felt to be a direct consequence of treatment-related toxicity (e.g. intestinal infection following mucosal barrier breakdown), and with the exception of constitutional symptoms if recovery to Grade ≤2 within 14 days. The National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 will be used.'}, {'measure': 'Event-free Survival (EFS) Rate (Phase 2)', 'timeFrame': 'From the start of study treatment, assessed at 6 months and 1 year', 'description': 'A two-stage design will be used to evaluate the EFS. Patients treated at the maximum tolerated dose (MTD) from the phase 1 portion of the trial will be used in the phase 2 analysis. If censoring occurs, secondary analyses analyzing 6-month or 1-year EFS accounting for censoring will be done, including estimating 6-month or 1-year EFS using the Kaplan-Meier method. The first stage of the two-stage phase 2 design will evaluate 30 patients. If 20 or more of the first 30 patients are alive without event at 6-months after study registration, an additional 30 patients will be enrolled. If 46 or more of the 60 patients treated at the MTD are alive and without event at 6-months after study registration, the study will consider the regimen of interest for further investigation. Patients last known to be alive in CR were censored at date of last contact.'}], 'secondaryOutcomes': [{'measure': '30-day All-cause Mortality', 'timeFrame': 'Up to 5 years. 30-day all-cause mortality is reported', 'description': 'As a summary of adverse events (captured on trial using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0), 30-day all cause mortality is reported as a percent of patients treated at the MTD/RP2D.\n\nWill be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.'}, {'measure': 'Relapse-free Survival of GO3 Cohort', 'timeFrame': 'Up to 5 years. 2-year RFS reported.', 'description': 'RFS was calculated for participants who achieved a complete remission (with or without count recovery; CR or CRi) and measured from the date remission to the first of relapse from CR/CRi or death from any cause. Patients last known to be alive in CR /CRi were censored at date of last contact. Will be estimated using the Kaplan-Meier method. Time to relapse will be estimated using non-parametric estimates of the cumulative incidence curve with death analyzed as a competing event. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.'}, {'measure': 'Overall Survival', 'timeFrame': '3 years and 1 month', 'description': 'OS was calculated for all participants and measured from initial trial therapy to death from any cause. Patients last known ot be alive were censored at date of last contact. Will be estimated using the Kaplan-Meier method. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.'}, {'measure': 'Measurable Residual Disease (MRD) Rates and Remission Rates: CR', 'timeFrame': '90 days', 'description': 'Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.\n\nComplete response (CR) rate is defined as the frequency of patients achieving CR, which is defined by the European LeukemiaNet 2017 guidelines as bone marrow blasts \\<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 x 109/L (1000/mL); platelet count ≥100 x 109/L. (100 000/mL). MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry.\n\nAplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS.\n\nStatistical significance tests were not performed.'}, {'measure': 'Measurable Residual Disease (MRD) and Remission Rates: CRi (MRDneg)', 'timeFrame': '90 days', 'description': 'Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.\n\nComplete response with incomplete hematologic recovery (CRi) rate is defined as the frequency of patients achieving CRi, which is defined by the European LeukemiaNet 2017 guidelines as all CR criteria except for residual neutropenia (ANC \\<1.0 x 109/L \\[1000/mL\\]) or thrombocytopenia (platelet count \\<100 x 109/L \\[100,000/mL\\]). MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry.\n\nAplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS.\n\nStatistical significance tests were not performed.'}, {'measure': 'Measurable Residual Disease (MRD) and Remission Rates: CR/CRi', 'timeFrame': '90 days', 'description': 'Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.\n\nComplete response (CR) + complete response with incomplete hematologic recovery (CRi) rate is defined as the frequency of patients achieving CR or CRi per the European LeukemiaNet 2017 criteria as defined above. MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry.\n\nAplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS.\n\nStatistical significance tests were not performed.'}, {'measure': 'Measurable Residual Disease (MRD) and Remission Rates: MLFS (MRDneg)', 'timeFrame': '90 days', 'description': 'Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.\n\nMorphologic leukemia free state (MLFS) rate is defined as the frequency of patients achieving MLFS, which is defined by the European LeukemiaNet guidelines as bone marrow blasts \\<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. At least 200 cells should be enumerated or cellularity should be at least 10%. MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry.\n\nAplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS.\n\nStatistical significance'}, {'measure': 'Measurable Residual Disease (MRD) and Remission Rates: Alapasia (MRDneg)', 'timeFrame': '90 days', 'description': 'Will be estimated and 95% confidence intervals will be calculated. Regression models (logistic regression for binary endpoints, Cox regression for time-to-event endpoints \\[Cox models for the hazard of the subdistribution for events with competing risks\\]) will be used to compare outcomes with patients who have received GCLAM without GO at our institution, controlling for measured prognostic factors.\n\no Aplasia rate is defined in this protocol as frequency of patients without blood count recovery after chemotherapy and bone marrow examination showing hypocellularity not meeting cellularity criteria for morphologic leukemia free state (MLFS). MRD negative (MRDneg) status is defined as negative for leukemic markers by multiparameter flow cytometry.\n\nAplasia was defined as absence of tumoral cells but cellularity not meeting criteria for MLFS.\n\nStatistical significance tests were not performed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'This phase I/II trial studies the side effects and best dosing frequency of gemtuzumab ozogamicin when given in combination with granulocyte colony stimulating factor (G-CSF), cladribine, cytarabine and mitoxantrone (GCLAM) and to see how well they work in treating participants with acute myeloid leukemia or high-grade myeloid tumors (neoplasms) that have not been previously treated. Antibody-drug conjugates, such as gemtuzumab ozogamicin, act by directly delivering toxic chemotherapy to cancer cells. Granulocyte colony stimulating factor is a growth factor used to stimulate leukemia cells and render them more sensitive to chemotherapy drugs. Drugs used in chemotherapy, such as cladribine, cytarabine and mitoxantrone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving gemtuzumab ozogamicin in combination with G-CSF, cladribine, cytarabine and mitoxantrone hydrochloride may work better in treating participants with acute myeloid leukemia or high-grade myeloid neoplasm.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the maximum-tolerated dose (MTD) of gemtuzumab ozogamicin (GO) when added to GCLAM in patients with newly-diagnosed AML requiring induction chemotherapy. (Phase I) II. To evaluate the 6-month and 1-year event-free survival (EFS) rate with GO + GCLAM treated at the MTD. (Phase II)\n\nSECONDARY OBJECTIVES:\n\nI. Describe, within the limits of a phase 1/2 study, the toxicity profile of the study regimen.\n\nII. Compare, within the limits of a phase 1/2 study, measurable residual disease (MRD) rates with GO + GCLAM at the MTD to patients treated previously with GCLAM alone.\n\nIII. Estimate, within the limits of a phase 1/2 study, the relationship between MRD status after induction therapy and relapse risk/time to relapse as well as relapse-free and overall survival.\n\nIV. Compare, within the limits of a phase 1/2 study, complete remission rates with GO + GCLAM at the MTD to patients treated previously with GCLAM alone.\n\nV. Compare, within the limits of a phase 1/2 study, overall survival rates with GO + GCLAM at the MTD to patients treated previously with GCLAM alone VI. Evaluate, within the limits of a phase 1/2 study, the impact of GO dosing regimens on the duration of cytopenias.\n\nVII. Collect biological specimens for use for the future laboratory investigation of biomarkers for response to GO.\n\nOUTLINE: This is a phase I dose escalation study of gemtuzumab ozogamicin followed by a phase II study.\n\nINDUCTION THERAPY: Participants receive gemtuzumab ozogamicin intravenously (IV) either as a single dose on day 1, or as three doses on days 1, 4, and 7. Participants also receive G-CSF subcutaneously (SC) on days 0-5, cladribine IV over 2 hours on days 1-5, cytarabine IV over 2 hours on days 1-5, and mitoxantrone hydrochloride IV on days 1-3. Patients who do not achieve a CR or CRi following the first cycle of induction are eligible for a second cycle, which is given without gemtuzumab ozogamicin. Participants with a complete remission (CR) or complete remission with incomplete count recovery (CRi) may then proceed to Post-Remission Therapy.\n\nPOST-REMISSION THERAPY: Participants receive G-CSF, cladribine, and cytarabine as in Induction Therapy during cycle 1, and cytarabine IV every 12 hours on days 1-6 of cycles 2-3. Treatment repeats every month for up to 3 cycles in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, participants are followed up every 3 months for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of untreated "high-grade" myeloid neoplasm (≥ 10% blasts in blood or bone marrow) or acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2016 World Health Organization (WHO) classification; outside diagnostic material is acceptable to establish diagnosis; submission of peripheral blood specimen for flow cytometry performed at the study institution should be considered; diagnostic material must have been submitted for cytogenetic and/or molecular testing as clinically appropriate\n* Medically fit, as defined by treatment-related mortality (TRM) score ≤13.1 calculated with simplified model\n* The use of hydroxyurea prior to study registration is allowed; patients with symptoms/signs of hyperleukocytosis or white blood cells (WBC) \\> 100,000/uL can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg/m\\^2/dose) prior to enrollment\n* Patients may have received low-intensity treatment (e.g. azacitidine/decitabine, lenalidomide, growth factors) for antecedent low-grade myeloid neoplasm (i.e. \\< 10% blasts in blood and bone marrow)\n* Bilirubin ≤ 2.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to hepatic infiltration by AML, Gilbert\'s syndrome, or hemolysis (assessed within 14 days prior to study day 0)\n* Serum creatinine ≤ 2.0 mg/dL (assessed within 14 days prior to study day 0)\n* Left ventricular ejection fraction ≥ 45%, assessed within 12 months prior to study day 0, e.g. by multigated acquisition (MUGA) scan or echocardiography, or other appropriate diagnostic modality and no clinical evidence of congestive heart failure\n* Women of childbearing potential and men must agree to use adequate contraception\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Myeloid blast crisis of chronic myeloid leukemia (CML), unless patient is not considered candidate for tyrosine kinase inhibitor treatment\n* Concomitant illness associated with a likely survival of \\< 1 year\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials, and/or controlled or stable (e.g. if specific, effective therapy is not available/feasible or desired \\[e.g. known chronic viral hepatitis, human immunodeficiency virus (HIV)\\]); patient needs to be clinically stable as defined as being afebrile and hemodynamically stable for 24 hours; patients with fever thought to be likely secondary to leukemia are eligible\n* Known hypersensitivity to any study drug\n* Confirmed or suspected pregnancy or active breast feeding\n* Treatment with any other investigational anti-leukemia agent; in phase 2, treatment with a tyrosine kinase inhibitor for patients with FLT3-mutated AML is permissible'}, 'identificationModule': {'nctId': 'NCT03531918', 'briefTitle': 'Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'A Single-Center Phase 1/2 Study of Single- or Fractioned-Dose Gemtuzumab Ozogamicin in Combination With G-CSF, Cladribine, Cytarabine, and Mitoxantrone for Previously Untreated Adult Acute Myeloid Leukemia or High-Grade Myeloid Neoplasm', 'orgStudyIdInfo': {'id': '10000'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00776', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '10000', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'RG9218023', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (GO, GCLAM)', 'description': 'INDUCTION THERAPY: Participants receive gemtuzumab ozogamicin IV either as a single dose on day 1, or as three doses on days 1, 4, and 7. Participants also receive G-CSF SC on days 0-5, cladribine IV over 2 hours on days 1-5, cytarabine IV over 2 hours on days 1-5, and mitoxantrone hydrochloride IV on days 1-3. Patients who do not achieve a CR or CRi following the first cycle of induction are eligible for a second cycle, which is given without gemtuzumab ozogamicin. Participants with a CR or CRi may then proceed to Post-Remission Therapy.\n\nPOST-REMISSION THERAPY: Participants receive G-CSF, cladribine, and cytarabine as in Induction Therapy during cycle 1, and cytarabine IV every 12 hours on days 1-6 of cycles 2-3. Treatment repeats every month for up to 3 cycles in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Cladribine', 'Drug: Cytarabine', 'Drug: Gemtuzumab Ozogamicin', 'Biological: Recombinant Granulocyte Colony-Stimulating Factor', 'Other: Laboratory Biomarker Analysis', 'Drug: Mitoxantrone Hydrochloride']}], 'interventions': [{'name': 'Cladribine', 'type': 'DRUG', 'otherNames': ['2-CdA', '2CDA', 'CdA', 'Cladribina', 'Leustat', 'Leustatin', 'Leustatine', 'RWJ-26251'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (GO, GCLAM)']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['.beta.-Cytosine arabinoside', '1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-.beta.-D-Arabinofuranosylcytosine', '1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-Beta-D-arabinofuranosylcytosine', '1.beta.-D-Arabinofuranosylcytosine', '2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-', '2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-', 'Alexan', 'Ara-C', 'ARA-cell', 'Arabine', 'Arabinofuranosylcytosine', 'Arabinosylcytosine', 'Aracytidine', 'Aracytin', 'Aracytine', 'Beta-cytosine Arabinoside', 'CHX-3311', 'Cytarabinum', 'Cytarbel', 'Cytosar', 'Cytosine Arabinoside', 'Cytosine-.beta.-arabinoside', 'Cytosine-beta-arabinoside', 'Erpalfa', 'Starasid', 'Tarabine PFS', 'U 19920', 'U-19920', 'Udicil', 'WR-28453'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (GO, GCLAM)']}, {'name': 'Gemtuzumab Ozogamicin', 'type': 'DRUG', 'otherNames': ['Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody', 'CDP-771', 'CMA-676', 'gemtuzumab', 'hP67.6-Calicheamicin', 'Mylotarg', 'WAY-CMA-676'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (GO, GCLAM)']}, {'name': 'Recombinant Granulocyte Colony-Stimulating Factor', 'type': 'BIOLOGICAL', 'otherNames': ['143011-72-7', 'Recombinant Colony-Stimulating Factor 3', 'rhG-CSF'], 'description': 'Given SC', 'armGroupLabels': ['Treatment (GO, GCLAM)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (GO, GCLAM)']}, {'name': 'Mitoxantrone Hydrochloride', 'type': 'DRUG', 'otherNames': ['CL 232315', 'DHAD', 'DHAQ', 'Dihydroxyanthracenedione Dihydrochloride', 'Mitoxantrone Dihydrochloride', 'Mitoxantroni Hydrochloridum', 'Mitozantrone Hydrochloride', 'Mitroxone', 'Neotalem', 'Novantrone', 'Onkotrone', 'Pralifan'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (GO, GCLAM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Roland Walter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Clinical Research Division', 'investigatorFullName': 'Roland B Walter', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}