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

Recruiting

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT06323590
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

This will be a pilot study that will include patients with AML receiving intensive induction therapy with 7+3 +/- a third agent (for any actionable cytogenetics or mutations). All patients will have a planned mid-induction bone marrow assessment as standard of care. All patients will subsequently be observed for count recovery, regardless of bone marrow results and in the absence of peripheral blood disease proliferation, and an end of induction bone marrow biopsy will be performed either at count recovery or between days 28 and 42 in the absence of count recovery. Patients with complete remission (CR) will proceed to consolidation chemotherapy as determined by the treating investigator. Patients with refractory disease will proceed to further therapy as determined by the treating investigator. All patients will be followed for long-term outcomes.

Study Timeline

• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-21
• Study Start: 2024-05-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rates of complete remission	28 days	rates of complete remission in consecutive patients with AML, receiving standard induction chemotherapy, without intervening on the results of the mid-induction bone marrow biopsy.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States