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Study details
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Venetoclax in Combination with Busulfan for High-Risk AML/MDS

M.D. Anderson Cancer Center
NCT IDNCT04708054ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2/3

Target enrollment

324

Study length

about 6.2 years

Ages

18–70

Locations

1 site in TX

What this study is about

This trial is testing whether adding venetoclax to the standard treatment of busulfan, cladribine, and fludarabine improves outcomes for adults with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are undergoing stem cell transplant. The goal is to see if this combination can better control these cancers.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Busulfan
  • 2.Take Cladribine
  • 3.Take Fludarabine Phosphate
  • +3 more

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IVInjection / IV

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

busulfan, cladribine, Antineoplastic Agent [TC] (Nucleic Acid Synthesis Inhibitors), thiotepa, venetoclax

Drug routes

injection, intravenous, injection (Injection), oral

Endpoints

Primary: 1-year progression free survival (PFS)

Secondary: Graft-versus (vs.)-host disease-free, relapse-free survival (GRFS), Incidence of adverse events, Overall survival (OS)

Body systems

Oncology