Observing outcomes of patients with acute myeloid leukemia after mid-induction bone marrow biopsy

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

This study looks at how patients with acute myeloid leukemia do after having a mid-treatment bone marrow biopsy without getting more chemotherapy right away.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (other)
• Drugs / interventions: gemtuzumab, chemotherapy
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT06323590 on ClinicalTrials.gov

What this trial studies

This pilot study aims to observe the outcomes of patients with acute myeloid leukemia (AML) who undergo a standard mid-induction bone marrow biopsy without receiving an immediate second round of chemotherapy. Participants will receive intensive induction therapy and will be monitored for count recovery following the biopsy. An end of induction bone marrow biopsy will be performed based on recovery status, and patients will be followed for long-term outcomes. The study seeks to refine the role of mid-induction biopsies in the treatment of AML.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed acute myeloid leukemia undergoing intensive induction chemotherapy.

Not a fit: Patients with prior treatment for AML or those with uncontrolled active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment protocols for patients with acute myeloid leukemia by optimizing the timing of chemotherapy based on biopsy results.

How similar studies have performed: While this approach is observational and may not have been extensively tested, similar studies in hematology have shown the importance of timely interventions based on biopsy results.

Eligibility criteria

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

Where this trial is running

Birmingham, Alabama

• University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)

Study contacts

• Principal investigator: Omer Jamy — University of Alabama at Birmingham
• Study coordinator: Omer Jamy, MD

Conditions: Acute Myeloid Leukemia