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

Summary

The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy.

Eligibility

Inclusion 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.

Exclusion Criteria:

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

Conditions2

Locations1 site

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