Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-02-20 @ 10:44 AM
Study NCT ID:
NCT02728050
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2016-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017338', 'term': 'Cladribine'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D000077157', 'term': 'Sorafenib'}], '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': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'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'}, {'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'halpern2@uw.edu', 'phone': '206-606-1978', 'title': 'Anna Halpern, MD', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study was limited by its single-institution and non-randomized nature'}}, 'adverseEventsModule': {'timeFrame': 'From time of consent until 60 days after day 1 of each cycle, up to 5 years. Subjects can receive up to five cycles of therapy. After that, eligible subjects can receive maintenance therapy for up to one year. All-cause mortality was assessed for up to 5 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1, Dose Level 1', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Phase 1, Dose Level 2', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Phase 1, Dose Level 3', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Phase 1, Dose Level 4', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 4, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Phase 1, Dose Level 5', 'description': 'Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 3, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Phase 1, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Phase 2, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 27, 'seriousNumAtRisk': 37, 'deathsNumAffected': 10, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 45, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 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The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).'}], 'classes': [{'categories': [{'measurements': [{'value': '400', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 28 days of treatment', 'description': 'MTD/RP2D will be defined as the highest dose studied in which the incidence of dose-limiting toxicity (DLT) is \\< 33% assuming at least 6 patients have been treated at this dose. DLTs were defined as: 1) grade ≥3 non-hematologic toxicity lasting \\>48 hours leading to \\>7-day delay of the next cycle; 2) grade ≥4 non-hematologic toxicity if no recovery to grade ≤2 in 14 days (both excluding febrile neutropenia/ infection); 3) Absolute neutrophil count \\<500/ µL or platelet count \\<50,000/µL for \\>49 days after CLAGM+S without marrow evidence of AML. Doses were escalated up to dose level six if \\<2/6 patients out of each cohort of 6 had a DLT (some cohorts were expanded to 12 patients while awaiting completion of DLT monitoring period). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).', 'unitOfMeasure': 'mg BID', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phase I and II: Rate of Minimal Residual Disease Negative (MRDneg) Complete Response (CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Dose Level 1', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG001', 'title': 'Phase 1, Dose Level 2', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG002', 'title': 'Phase 1, Dose Level 3', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG003', 'title': 'Phase 1, Dose Level 4', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG004', 'title': 'Phase 1, Dose Level 5', 'description': 'Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG005', 'title': 'Phase 1, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG006', 'title': 'Phase 2, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'groupDescription': 'Participants on study receiving CLAGM-S were compared to a historical cohort of newly diagnosed AML/high-risk MDS patients treated with CLAG-M alone, matched for mitoxantrone dose, age, and TRM score.\n\nNumber of participants in historical cohort = 71. Number of participants in historical cohort who achieved MRD-negative CR = 55 (77.46%)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '56 days (2 cycles of induction chemotherapy)', 'description': "We will determine if the addition of sorafenib to CLAG-M improves the rate of MRDneg CR compared to our institution's historical control of CLAG-M alone in adults with newly-diagnosed AML/high-risk MDS.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complete Remission (CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Dose Level 1', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG001', 'title': 'Phase 1, Dose Level 2', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG002', 'title': 'Phase 1, Dose Level 3', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG003', 'title': 'Phase 1, Dose Level 4', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG004', 'title': 'Phase 1, Dose Level 5', 'description': 'Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG005', 'title': 'Phase 1, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG006', 'title': 'Phase 2, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}], 'classes': [{'categories': [{'title': 'CR: MRD-negative', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}]}, {'title': 'CR: MRD-positive', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'CRi: MRD-negative', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'CRi: MRD-positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'MLFS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Resistant disease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'Complete remission (CR) is defined as bone marrow blasts \\<5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥1.0 x 10\\^9/L; platelet count ≥100 x 10\\^9/L.\n\nCR with incomplete hematologic recovery (CRi) is CR with ANC \\<1.0 x10\\^9/L or platelet count \\<100 x 10\\^9/L.\n\nMeasurable residual disease (MRD) is assessed by multiparameter flow cytometry and PCR.\n\nMorphologic leukemia free state (MLFS) is bone marrow blasts \\<5%; absence of circulating blasts; absence of extramedullary disease; no hematologic recovery.\n\nResistant disease is defined as not not meeting the criteria for CR, CRi, MLFS.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Dose Level 1', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG001', 'title': 'Phase 1, Dose Level 2', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG002', 'title': 'Phase 1, Dose Level 3', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG003', 'title': 'Phase 1, Dose Level 4', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG004', 'title': 'Phase 1, Dose Level 5', 'description': 'Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG005', 'title': 'Phase 1, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG006', 'title': 'Phase 2, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'ORR, defined as CR+CRi, rates of patients treated with CLAG-M with sorafenib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CLAGM+Sorafenib Phase 2', 'description': 'Participants enrolled during phase 2 and treated at the recommended phase 2 dose that was established in phase 1. Patients treated at the RP2D in the Phase 1 were included in the Phase 2 analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': '12-month overall survival', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CLAGM+Sorafenib Phase 2', 'description': 'Participants enrolled during phase 2 and treated at the recommended phase 2 dose that was established in phase 1. Patients treated at the RP2D in the Phase 1 were included in the Phase 2 analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': '12-month event free survival', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relapse-free Survival (RFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CLAGM+Sorafenib Phase 2', 'description': 'Participants enrolled during phase 2 and treated at the recommended phase 2 dose that was established in phase 1. Patients treated at the RP2D in the Phase 1 were included in the Phase 2 analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': '12-month relapse free survival (RFS)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1, Dose Level 1', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG001', 'title': 'Phase 1, Dose Level 2', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG002', 'title': 'Phase 1, Dose Level 3', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG003', 'title': 'Phase 1, Dose Level 4', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG004', 'title': 'Phase 1, Dose Level 5', 'description': 'Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG005', 'title': 'Phase 1, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}, {'id': 'OG006', 'title': 'Phase 2, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m2 days 1-5 Cytarabine IV 2g/m2 days 1-5'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1, Dose Level 1', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'FG001', 'title': 'Phase 1, Dose Level 2', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'FG002', 'title': 'Phase 1, Dose Level 3', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'FG003', 'title': 'Phase 1, Dose Level 4', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'FG004', 'title': 'Phase 1, Dose Level 5', 'description': 'Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'FG005', 'title': 'Phase 1, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'FG006', 'title': 'Phase 2, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}, {'value': '84', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1, Dose Level 1', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 10mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'BG001', 'title': 'Phase 1, Dose Level 2', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 12mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'BG002', 'title': 'Phase 1, Dose Level 3', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 15mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'BG003', 'title': 'Phase 1, Dose Level 4', 'description': 'Sorafenib 200mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'BG004', 'title': 'Phase 1, Dose Level 5', 'description': 'Sorafenib 400mg AM, 200mg PM PO days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'BG005', 'title': 'Phase 1, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'BG006', 'title': 'Phase 2, Dose Level 6', 'description': 'Sorafenib 400mg PO BID days 10-19 Mitoxantrone 18mg/m\\^2 IV days 1-3 G-CSF SQ 5µcg/kg days 0-5 Cladribine IV 5mg/m\\^2 days 1-5 Cytarabine IV 2g/m\\^2 days 1-5'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '55'}, {'value': '49.5', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '53'}, {'value': '41', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '59'}, {'value': '49', 'groupId': 'BG003', 'lowerLimit': '35', 'upperLimit': '59'}, {'value': '56', 'groupId': 'BG004', 'lowerLimit': '30', 'upperLimit': '59'}, {'value': '48', 'groupId': 'BG005', 'lowerLimit': '23', 'upperLimit': '57'}, {'value': '49', 'groupId': 'BG006', 'lowerLimit': '21', 'upperLimit': '60'}, {'value': '48', 'groupId': 'BG007', 'lowerLimit': '21', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '38', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '46', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}, {'value': '73', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '65', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease classification', 'classes': [{'categories': [{'title': 'AML', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}, {'value': '69', 'groupId': 'BG007'}]}, {'title': 'MDS', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}]}, {'title': 'CMML-2', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'MRC Risk Category', 'classes': [{'categories': [{'title': 'Favorable', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}, {'title': 'Intermediate', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}]}, {'title': 'Adverse', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ELN 2017 Risk Group', 'classes': [{'categories': [{'title': 'Favorable', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}]}, {'title': 'Intermediate', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}]}, {'title': 'Adverse', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '32', 'groupId': 'BG007'}]}, {'title': 'Unable to assess', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Secondary Disease', 'classes': [{'categories': [{'title': 'Secondary disease', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}]}, {'title': 'No secondary disease', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '71', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Status', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}]}, {'title': '1', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '68', 'groupId': 'BG007'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '0: Fully active, able to carry on all pre-disease performance without restriction\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\n2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours\n3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours\n4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair\n5. Dead', 'unitOfMeasure': 'Participants'}, {'title': 'Treatment Related Mortality (TRM) Score', 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'groupId': 'BG000', 'lowerLimit': '0.20', 'upperLimit': '2.83'}, {'value': '2.00', 'groupId': 'BG001', 'lowerLimit': '1.06', 'upperLimit': '4.19'}, {'value': '2.72', 'groupId': 'BG002', 'lowerLimit': '0.6', 'upperLimit': '7.2'}, {'value': '2.19', 'groupId': 'BG003', 'lowerLimit': '1.2', 'upperLimit': '12.26'}, {'value': '1.57', 'groupId': 'BG004', 'lowerLimit': '0.56', 'upperLimit': '2.28'}, {'value': '1.28', 'groupId': 'BG005', 'lowerLimit': '0.19', 'upperLimit': '5.56'}, {'value': '2.21', 'groupId': 'BG006', 'lowerLimit': '0.26', 'upperLimit': '8.42'}, {'value': '1.96', 'groupId': 'BG007', 'lowerLimit': '0.19', 'upperLimit': '12.26'}]}]}], 'paramType': 'MEDIAN', 'description': 'Our institution defines treatment-related mortality (TRM) as death within 28 days from initiation of chemotherapy based on observation that risk of death declines once 4 weeks has elapsed from treatment start. Calculation is used to predict TRM (scale from 0-100) using age, performance status, if they have secondary AML, albumin, creatinine, platelet count, white blood cell count, and peripheral blood blast percentage. The higher the TRM score, the higher the risk of TRM. Calculator and table of relationship between TRM score and TRM probability found here https://trmcalculator.fredhutch.org/', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'FLT3 Mutations', 'classes': [{'categories': [{'title': 'FLT3-ITD mutation', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}]}, {'title': 'FLT3-TKD mutation', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'No FLT3 mutations', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}]}, {'title': 'FLT3 mutation status unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mutations in FLT3 are the most common genetic alteration in AML. The FLT3 gene provides instructions for making a protein called fms-like tyrosine kinase 3 (FLT3). Two basic categories of mutation are recognized in FLT3: (1) FLT3-ITD, internal tandem duplication (ITD) within the FLT3 juxtamembrane domain and (2) FLT3-TKD, activating missense mutations affecting the tyrosine kinase domain (TKD).', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-19', 'size': 1496535, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-24T19:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-30', 'studyFirstSubmitDate': '2016-03-14', 'resultsFirstSubmitDate': '2023-01-26', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-07', 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Mitoxantrone', 'timeFrame': 'First 28 days of treatment', 'description': 'MTD/RP2D will be defined as the highest dose studied in which the incidence of dose-limiting toxicity (DLT) is \\< 33% assuming at least 6 patients have been treated at this dose. DLTs were defined as: 1) grade ≥3 non-hematologic toxicity lasting \\>48 hours leading to \\>7-day delay of the next cycle; 2) grade ≥4 non-hematologic toxicity if no recovery to grade ≤2 in 14 days (both excluding febrile neutropenia/ infection); 3) Absolute neutrophil count \\<500/ µL or platelet count \\<50,000/µL for \\>49 days after CLAGM+S without marrow evidence of AML. Doses were escalated up to dose level six if \\<2/6 patients out of each cohort of 6 had a DLT (some cohorts were expanded to 12 patients while awaiting completion of DLT monitoring period). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).'}, {'measure': 'Phase 1: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of Sorafenib', 'timeFrame': 'First 28 days of treatment', 'description': 'MTD/RP2D will be defined as the highest dose studied in which the incidence of dose-limiting toxicity (DLT) is \\< 33% assuming at least 6 patients have been treated at this dose. DLTs were defined as: 1) grade ≥3 non-hematologic toxicity lasting \\>48 hours leading to \\>7-day delay of the next cycle; 2) grade ≥4 non-hematologic toxicity if no recovery to grade ≤2 in 14 days (both excluding febrile neutropenia/ infection); 3) Absolute neutrophil count \\<500/ µL or platelet count \\<50,000/µL for \\>49 days after CLAGM+S without marrow evidence of AML. Doses were escalated up to dose level six if \\<2/6 patients out of each cohort of 6 had a DLT (some cohorts were expanded to 12 patients while awaiting completion of DLT monitoring period). The dose level at which dose escalation was stopped was the recommended phase 2 dose (RP2D).'}, {'measure': 'Phase I and II: Rate of Minimal Residual Disease Negative (MRDneg) Complete Response (CR)', 'timeFrame': '56 days (2 cycles of induction chemotherapy)', 'description': "We will determine if the addition of sorafenib to CLAG-M improves the rate of MRDneg CR compared to our institution's historical control of CLAG-M alone in adults with newly-diagnosed AML/high-risk MDS."}], 'secondaryOutcomes': [{'measure': 'Complete Remission (CR)', 'timeFrame': 'Up to 5 years', 'description': 'Complete remission (CR) is defined as bone marrow blasts \\<5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥1.0 x 10\\^9/L; platelet count ≥100 x 10\\^9/L.\n\nCR with incomplete hematologic recovery (CRi) is CR with ANC \\<1.0 x10\\^9/L or platelet count \\<100 x 10\\^9/L.\n\nMeasurable residual disease (MRD) is assessed by multiparameter flow cytometry and PCR.\n\nMorphologic leukemia free state (MLFS) is bone marrow blasts \\<5%; absence of circulating blasts; absence of extramedullary disease; no hematologic recovery.\n\nResistant disease is defined as not not meeting the criteria for CR, CRi, MLFS.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to 5 years', 'description': 'ORR, defined as CR+CRi, rates of patients treated with CLAG-M with sorafenib.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '12 months', 'description': '12-month overall survival'}, {'measure': 'Event-free Survival (EFS)', 'timeFrame': '12 months', 'description': '12-month event free survival'}, {'measure': 'Relapse-free Survival (RFS)', 'timeFrame': '12 months', 'description': '12-month relapse free survival (RFS)'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Up to 5 years', 'description': 'Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Biphenotypic Leukemia', 'Acute Myeloid Leukemia', 'de Novo Myelodysplastic Syndrome', 'Myelodysplastic Syndrome', 'Myeloproliferative Neoplasm']}, 'referencesModule': {'references': [{'pmid': '37339483', 'type': 'DERIVED', 'citation': 'Halpern AB, Rodriguez-Arboli E, Othus M, Garcia KA, Percival MM, Cassaday RD, Oehler VG, Becker PS, Appelbaum JS, Abkowitz JL, Orozco JJ, Keel SB, Hendrie PC, Scott BL, Ghiuzeli MC, Estey EH, Walter RB. Phase 1/2 study of sorafenib added to cladribine, high-dose cytarabine, G-CSF, and mitoxantrone in untreated AML. Blood Adv. 2023 Sep 12;7(17):4950-4961. doi: 10.1182/bloodadvances.2023010392.'}]}, 'descriptionModule': {'briefSummary': 'This phase I/II trial studies the side effects and best dose of filgrastim (granulocyte colony-stimulating factor \\[G-CSF\\]), cladribine, cytarabine, and mitoxantrone, when given together with sorafenib and to see how well they work in treating patients with newly-diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome (likely to be more aggressive). Drugs used in chemotherapy, such as cladribine, cytarabine, and mitoxantrone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Colony-stimulating factors, such as filgrastim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving filgrastim, cladribine, cytarabine, and mitoxantrone together with sorafenib may kill more cancer cells.', 'detailedDescription': 'OUTLINE: This is a phase I, dose-escalation study of mitoxantrone and sorafenib followed by a phase II study.\n\nINDUCTION: Patients receive mitoxantrone intravenously (IV) over 60 minutes on days 1-3 and sorafenib orally (PO) twice daily (BID) on days 10-19 in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim subcutaneously (SC) once daily (QD) on days 0-5, cladribine IV QD over 2 hours on days 1-5, and cytarabine IV QD over 2 hours on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients achieving partial remission (including MRD positive \\[pos\\] CR, CR with incomplete platelet recovery \\[CRp\\], and CR with incomplete count recovery \\[CRi\\]) or persistent AML may receive up to 2 cycles of induction therapy per the discretion of the treating physician.\n\nPOST-REMISSION: Patients receive sorafenib PO BID on days 8-27 or 3 days prior to next cycle of treatment, whichever occurs first. Patients also receive filgrastim subcutaneously SC QD on days 0-5, cladribine IV QD over 2 hours on days 1-5, and cytarabine IV QD over 2 hours on days 1-5 in the absence of disease progression or unacceptable toxicity. Patients achieving MRDneg CR may receive up to 4 cycles of post-remission therapy. Patients achieving disease response (MRDpos CR, CRi/CRp, or persistent disease) may receive up to two induction cycles and 1 cycle of post-remission therapy with mitoxantrone omitted in cycle 3. If they then enter MRDneg CR, they can proceed with up to a total of 4 cycles of post-remission therapy.\n\nMAINTENANCE THERAPY: Patients achieving MRDneg CR may receive maintenance therapy of sorafenib PO BID for up to 1 year.\n\nAfter completion of study treatment, patients are followed up every 3 months for up to 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-60 years, inclusive\n* Newly diagnosed disease with either a diagnosis of "high-risk" MDS (\\>= 10% blasts in marrow or blood), high-risk myeloproliferative neoplasm (MPN; \\>= 10% blasts in blood or bone marrow), or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2008 World Health Organization (WHO) classification. Patients with biphenotypic AML are eligible; such "high-risk" MDS or MPN have natural history much closer to AML than to lower risk MDS or MPN and have responded similarly to "AML-type" therapy.\n* Outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution by appropriate clinical staff. Flow cytometric analysis of peripheral blood and/or bone marrow should be performed according to institutional practice guidelines.\n* Treatment-related mortality (TRM) score =\\< 13.1 as calculated with simplified model\n* The use of hydroxyurea prior to study registration is allowed. Patients with symptoms/signs of hyperleukocytosis, white blood cell (WBC) \\> 100,000/uL, or acute symptoms can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg/m\\^2/dose) prior to study day 0 enrollment\n* Bilirubin =\\< 2 times institutional upper limit of normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert\'s syndrome, or hemolysis (assessed within 10 days prior to study day 0)\n* Serum creatinine =\\< 2.0 mg/dL (assessed within 10 days prior to study day 0)\n* Left ventricular ejection fraction \\>= 45%, assessed within 3 months prior to study day 0, e.g. by multi gated acquisition scan (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 beginning at the signing of the consent until at least 3 months after the last dose of study drug\n* Provide written informed consent (or legal representative)\n\nExclusion Criteria:\n\n* Myeloid blast crisis of chronic myeloid leukemia (CML), unless patient is not considered candidate for CML-directed tyrosine kinase inhibitor treatment (excluding sorafenib)\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. chronic viral hepatitis, human immunodeficiency virus (HIV)\\]). Patient needs to be clinically stable as defined as being afebrile and hemodynamically stable for 24-48 hours prior to study day 0, unless fever is thought to be secondary to the underlying hematologic disease.\n* Active or clinically significant (or symptomatic) cardiac disease, including active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin within the last 3 months, unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before study day 0\n* Previous receipt of azacitidine, decitabine, anthracyclines, cytarabine, or other nucleoside analogues for treatment of AML or MPN/MDS other than as noted for cytarabine\n* Pregnancy or lactation\n* Concurrent treatment with any other investigational agent that has anti-leukemia activity or another drug with anti-AML-activity'}, 'identificationModule': {'nctId': 'NCT02728050', 'briefTitle': 'Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Addition of Sorafenib to G-CSF, Cladribine, Cytarabine and Mitoxantrone (G-CLAM) in Adults With Newly-Diagnosed Acute Myeloid Leukemia (AML) Independent of FLT3-ITD Status: A Phase 1/2 Study', 'orgStudyIdInfo': {'id': '9510'}, 'secondaryIdInfos': [{'id': 'NCI-2016-00286', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '9510', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'P30CA015704', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015704', 'type': 'NIH'}, {'id': 'RG1016000', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (sorafenib, G-CLAM)', 'description': 'See Detailed Description.', 'interventionNames': ['Drug: Cladribine', 'Drug: Cytarabine', 'Biological: Filgrastim', 'Other: Laboratory Biomarker Analysis', 'Other: Quality-of-Life Assessment', 'Drug: Mitoxantrone', 'Drug: Sorafenib']}], 'interventions': [{'name': 'Cladribine', 'type': 'DRUG', 'otherNames': ['2-CdA', '2CDA', 'CdA', 'Cladribina', 'Leustat', 'Leustatin', 'Leustatine', 'RWJ-26251'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (sorafenib, G-CLAM)']}, {'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 (sorafenib, G-CLAM)']}, {'name': 'Filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['FILGRASTIM, LICENSE HOLDER UNSPECIFIED', 'G-CSF', 'Neupogen', 'r-metHuG-CSF', 'Recombinant Methionyl Human Granulocyte Colony Stimulating Factor', 'rG-CSF', 'Tevagrastim', 'Nivestym', 'Filgrastim-aafi'], 'description': 'Given SC', 'armGroupLabels': ['Treatment (sorafenib, G-CLAM)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (sorafenib, G-CLAM)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment (sorafenib, G-CLAM)']}, {'name': 'Mitoxantrone', 'type': 'DRUG', 'otherNames': ['Dihydroxyanthracenedione', 'Mitozantrone'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (sorafenib, G-CLAM)']}, {'name': 'Sorafenib', 'type': 'DRUG', 'otherNames': ['284461-73-0', 'BAY 43-9006', 'Bay-439006'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (sorafenib, G-CLAM)']}]}, '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': 'Anna Halpern', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Anna Halpern', 'investigatorAffiliation': 'University of Washington'}}}}