Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study

Eligibility Criteria

• 1. Adult male or female, age ≥18
• 2. Patients with newly diagnosed AML (de novo or secondary), treated with intensive induction chemotherapy (7+3+/-3rd agent). The 3rd agent will be midostaurin for FLT3-mutant AML or gemtuzumab ozogamicin for core-binding factor AML. Patients on clinical trial with an investigational agent added to 7+3, may be enrolled on the protocol after discussion between the investigators and medical monitors.
• 3. Prior use of hypomethylating agents, lenalidomide, erythropoiesis stimulating agents and growth factors as allowed for treatment of myelodysplastic syndrome. Prior treatment for AML is not allowed.
• 4. Cardiac function: Ejection fraction \>50-55%
• 5. Adequate organ function for receipt for induction chemotherapy
• 6. Patients with HIV and Hepatitis B or C should have controlled disease.
• 7. Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment.
• 1. Any other active malignancy requiring treatment or with expected survival ≤1 year.
• 2. Recipients of prior allogeneic stem cell transplant.
• 3. Patients with psychiatric illness or social situation that would limit compliance with the study requirements.
• 4. Patients with active CNS disease
• 5. Patients with APL
• 6. Received any investigational drugs within the 14 days prior to the first day of induction
• 7. Pregnant and/or breastfeeding