Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
Previously Untreated Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Previously Untreated Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- Adults, age 60 years or older at the time of diagnosis unless in a specific known cytogenetic and genomic group for which treatment in Group A or B is allowed by the sub-study where age 18 and older is allowed. Patients < 60 years old who are screened but do not fall within the cytogenetic and genomic open sub-studies would still be followed on the Master Protocol and not considered screen fails.
- Subjects must be able to understand and provide written informed consent
- Cohort Inclusion Criteria - Group A: Subjects must have previously untreated acute myeloid leukemia (AML) according to the WHO classification with no prior treatment other than hydroxyurea. Subjects with blasts % in bone marrow of 10% to 19% or blasts in blood of 10% to 19% will be allowed to enroll to this group. For previously untreated subjects with ≥ 20% blasts in bone marrow or blood only: Prior therapy for myelodysplastic syndrome (MDS), myeloproliferative syndromes (MPD), or aplastic anemia is permitted but not with hypomethylating agents.
- Cohort Inclusion Criteria - Group B: Subjects must have relapsed or refractory AML according to the WHO classification. For study purposes, refractory AML is defined as failure to ever achieve CR or recurrence of AML within 6 months of achieving CR; relapsed AML is defined as all others with disease after prior remission. For select genomic aberrations specified in the studies, patients ≥ 18 years of age may be allowed to enroll in this portion of the study.
Exclusion Criteria:
- Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML or involved with 10% to 19% blasts to enter the study)
- Acute promyelocytic leukemia
- Symptomatic central nervous system (CNS) involvement by AML
- Signs of leukostasis requiring urgent therapy
- Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis
- Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up
- Any other significant medical condition, including psychiatric illness or laboratory abnormality, that would preclude the patient participating in the trial or would confound the interpretation of the results of the trial
Sites / Locations
- Mayo Clinic Arizona
- UCLA Ronald Reagan Medical CenterRecruiting
- University of California, San FranciscoRecruiting
- University of Colorado
- University of Florida Health Shands Cancer Hospital
- Mayo Clinic Florida
- Emory UniversityRecruiting
- University of ChicagoRecruiting
- University of Kansas Clinical Research CenterRecruiting
- University of Maryland Medical CenterRecruiting
- Mayo Clinic Minnesota
- Memorial Sloan Kettering Cancer CenterRecruiting
- UNC Hospitals, University of North Carolina at Chapel HillRecruiting
- University of Cincinnati Medical CenterRecruiting
- Ohio State UniversityRecruiting
- Oregon Health & Science UniversityRecruiting
- UPMC Hillman Cancer CenterRecruiting
- University of Texas SouthwesternRecruiting
- Huntsman Cancer Institute, University of Utah
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Experimental
BAML-16-001-S1 (Closed)
BAML-16-001-S2 (Closed)
BAML-16-001-S3 (Closed)
BAML-16-001-S4 (Closed)
BAML-16-001-S5 (Closed)
BAML-16-001-S6 (Closed)
BAML-16-001-S9 (Closed)
BAML-16-001-S16 (Closed)
BAML-16-001-S8
BAML-16-001-S10 (Closed)
BAML-16-001-S14 (Closed)
BAML-16-001-S18 (Closed)
BAML-16-001-S17
BAML-16-001-S12 (Arm A)
BAML-16-001-S12 (Arm B)
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