Clinical Trials

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

Eligibility last updated 6/3/22. Questions regarding updates should be directed to the study team contact.