Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorM.D. Anderson Cancer Center
About this trial
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 criteria
Qualifiers
Age ≥ 18 and ≤ 70 years. English and non-English speaking patients are eligible.
ELN17 adverse risk prognostic group irrespective of remission status (see Appendix 2)
Measurable residual disease positive (MRD +)
Not in complete remission including complete remission without count recovery (Cri) and/or morphologic leukemia free state (MLFS), primary refractory, or relapsed disease. See Appendix 3 for details.
Disqualifiers
Subject is known to be positive for HIV.
Subject has cognitive impairments and/or is a prisoner.
Subject has acute promyelocytic leukemia
Subject has known active CNS involvement with AML.
Trial design
Treatments tested in this trial
- Busulfan
- Cladribine
- Fludarabine Phosphate
- Hematopoietic Cell Transplantation
- Thiotepa
- Venetoclax
Treatment groups
324 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov