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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323590
• Other study ID #: UAB 2372
• Secondary ID: UAB
• Status: Recruiting
• Start date: May 2, 2024
• Est. completion date: May 2028

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Omer Jamy, MD
• Phone: 2059342721
• Email: omerjamy[@]uabmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2028
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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