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

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

Trial Details

NCT ID
NCT04708054
Phase
PHASE2 / PHASE3
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Busulfan
  • Cladribine
  • Fludarabine Phosphate
  • Hematopoietic Cell Transplantation
  • Thiotepa
  • Venetoclax
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Age ≥ 18 and ≤ 70 years. English and non-English speaking patients are eligible.
  • Patients with acute myeloid leukemia who have previously received induction therapy and one of the following high-risk features:
  • ELN17 adverse risk prognostic group irrespective of remission status (see Appendix 2)
  • Measurable residual disease positive (MRD +)

For full eligibility, visit ClinicalTrials.gov.

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