A PHASE II TRIAL OF EPIGENETIC PRIMING IN PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA

Inclusion Criteria

Patients must have one of the following diagnoses:

Acute myeloid leukemia
Myeloid sarcoma (also referred to as extramedullary myeloid tumor, granulocytic sarcoma, or chloroma), with or without evidence of a leukemia process in the bone marrow or peripheral blood, with confirmation of myeloid differentiation, or
High grade myelodysplastic syndrome (MDS) with greater than 5% blasts, or
Patients with treatment related myeloid neoplasms including AML and MDS

No prior therapy for this malignancy except for one dose of intrathecal therapy and the use of
hydroxyurea or low-dose cytarabine

Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment, and

Male and female participants of reproductive potential must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

Exclusion Criteria

Down syndrome

Acute promyelocytic leukemia (APL)

BCR-ABL1 chronic myeloid leukemia in blast crisis (CML-BC)

Juvenile myelomonocytic leukemia (JMML)

Fanconi anemia (FA)

Kostmann syndrome

Shwachman syndrome

Other bone marrow failure syndromes or low grade (<5% bone marrow blasts) MDS.

Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.

Use of investigational agents within 30 days or any anticancer therapy for this malignancy within 2 weeks before study entry with the exception of IT therapy, hydroxyurea, or low-dose cytarabine as stated above. The patient must have recovered from all acute toxicities from any previous therapy.

Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).

Pregnant or lactating.

Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

Prior chemotherapy, with the exception of hydroxyurea or low-dose cytarabine as stated above. The patient must have recovered from all acute toxicities from any previous therapy.

Patients with treatment related myeloid neoplasms with cumulative anthracyclines greater than 230 mg/m2 doxorubicin equivalents.