RecruitingPhase 2Phase 3NCT04708054

Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS


Sponsor

M.D. Anderson Cancer Center

Enrollment

324 participants

Start Date

Oct 21, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies the effect of venetoclax together with busulfan, cladribine, and fludarabine in treating patients with high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing stem cell transplant. Chemotherapy drugs, such as venetoclax, busulfan, cladribine, and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax to the current standard of care stem cell transplant regimen of busulfan, fludarabine, and cladribine may help to control high-risk acute myeloid leukemia or myelodysplastic syndrome.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding venetoclax (a targeted drug that helps trigger cancer cell death) to a chemotherapy conditioning regimen (called fractionated busulfan) before a stem cell transplant can improve outcomes for patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). **You may be eligible if...** - You are 18 to 70 years old - You have AML that is high-risk, not in full remission, or has residual cancer detectable on sensitive tests (MRD positive) - OR you have high-risk MDS - You are eligible for and are planning an allogeneic stem cell transplant **You may NOT be eligible if...** - You are over 70 years old - You have significant organ dysfunction (heart, lung, liver, or kidney) - You have active uncontrolled infection - You cannot tolerate the transplant conditioning regimen 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

DRUGBusulfan

Given IV

DRUGCladribine

Given IV

DRUGFludarabine Phosphate

Given IV

PROCEDUREHematopoietic Cell Transplantation

Undergo stem cell transplantation

DRUGThiotepa

Given IV

DRUGVenetoclax

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04708054


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