RecruitingPhase 1NCT07044544

Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies

A Phase I Trial to Evaluate the Safety and Efficacy of Addition of Novel Anti-leukemia Agents to Flu/Mel RIC Transplant for High-risk Myeloid Malignancies


Sponsor

University of Alabama at Birmingham

Enrollment

20 participants

Start Date

Jul 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine the safety of adding Decitabine and Venetoclax to patients undergoing reduced intensity allogenic transplantation for treatment of hematologic malignances with Fludarabine and Melphalan.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a reduced-intensity stem cell transplant approach — using fludarabine and melphalan as conditioning chemotherapy — combined with novel anti-leukemia agents for patients with myeloid blood cancers (such as AML or MDS). The goal is to see whether adding these new agents to the transplant preparation can improve outcomes while keeping the treatment more tolerable than full-intensity transplant regimens. **You may be eligible if...** - You are between 18 and 75 years old - You have a myeloid blood cancer (such as AML or MDS) and are a candidate for a stem cell transplant - You have a compatible stem cell donor — either a matched sibling or an unrelated donor with an adequate HLA match - Your donor is willing and medically able to donate peripheral blood stem cells **You may NOT be eligible if...** - You do not have a suitable matched donor - Your overall health does not allow you to safely undergo a stem cell transplant - You have active uncontrolled infections - You have significant organ dysfunction that would make the conditioning regimen unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGG-CSF

Granulocyte colony-stimulating factor (G-CSF) is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.

DRUGDecitabine

Decitabine is a hypomethylating agent.

DRUGVenetoclax

Venetoclax is a selective inhibitor of BCL-2 protein.


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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NCT07044544


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