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

NCT06323590 | Recruiting DMC

• 2 other identifiers: UAB 2372UAB
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• rates of complete remission

  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.

  28 days

Study Arms (1)

Cohort A

Patients with AML, receiving standard induction chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult male or female, age ≥18
• 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.
• 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.
• Cardiac function: Ejection fraction \>50-55%
• Adequate organ function for receipt for induction chemotherapy
• Patients with HIV and Hepatitis B or C should have controlled disease.
• Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment.

You may not qualify if:

• Any other active malignancy requiring treatment or with expected survival ≤1 year.
• Recipients of prior allogeneic stem cell transplant.
• Patients with psychiatric illness or social situation that would limit compliance with the study requirements.
• Patients with active CNS disease
• Patients with APL
• Received any investigational drugs within the 14 days prior to the first day of induction
• Pregnant and/or breastfeeding

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Omer Jamy

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omer Jamy, MD

CONTACT

2059342721; omerjamy@uabmc.edu

Omer Jamy

CONTACT

2059342721; omerjamy@uabmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: May 2, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

US (1)