Acute Myeloid Leukemia Clinical Trial

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

60

Study ID:

NCT06323590

Recruitment Status:

Not yet recruiting

Sponsor:

University of Alabama at Birmingham

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States More Info
Omer Jamy
Contact
205-934-2721
[email protected]
Omer Jamy
Contact
2059342721
[email protected]
Omer Jamy
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

60

Study ID:

NCT06323590

Recruitment Status:

Not yet recruiting

Sponsor:


University of Alabama at Birmingham

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.