Actively Recruiting
Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS
Led by M.D. Anderson Cancer Center · Updated on 2026-02-19
324
Participants Needed
1
Research Sites
323 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years for Phase II; 18 to 65 years for Phase III
- Diagnosed with acute myeloid leukemia with high-risk features such as ELN adverse risk or measurable residual disease positive
- Diagnosed with myelodysplastic syndrome or chronic myelomonocytic leukemia with poor cytogenetic risk or specific gene mutations
- Available HLA-identical sibling, 7/8 matched unrelated donor, or haploidentical related donor
- Voluntarily signed informed consent
- Female participants of childbearing potential must have a negative pregnancy test
- Adequate liver function: AST and ALT less than 3 times the upper limit of normal, bilirubin less than 1.5 times the upper limit (unless due to non-hepatic causes)
- Adequate kidney function with creatinine clearance of at least 50 mL/min
You will not qualify if you...
- Known HIV positive status
- Cognitive impairments or prisoner status
- Diagnosis of acute promyelocytic leukemia
- Active central nervous system involvement with AML
- Uncontrolled or active infections (viral, bacterial, or fungal)
- Chronic hepatitis B or C requiring treatment (except certain prior vaccination or antibody positive cases)
- History of congestive heart failure requiring treatment or ejection fraction less than 50%, or unstable angina
- Lung function with corrected DLCO less than 50% or FEV1 less than 65%
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days prior to first study dose
- Serious unstable medical or psychiatric conditions interfering with safety or informed consent
- Prior allogeneic stem cell transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
U
Uday R. Popat
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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