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Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
Trial Status: active
This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic
screening followed by assigning and accruing simultaneously to a multi-study "Master
Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine
which sub-study, within this protocol, a participant will be assigned to evaluate
investigational therapies or combinations with the ultimate goal of advancing new
targeted therapies for approval. The study also includes a marker negative sub-study
which will include all screened patients not eligible for any of the biomarker-driven
sub-studies.
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
Additional locations may be listed on ClinicalTrials.gov for NCT03013998.
