Venetoclax as Part of Pre-Transplant Chemotherapy

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

What's the purpose of the 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.
Trial status

Accepting patients

Phase
Phase 2
Enrollment
324
Last Updated
1 week ago
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Experimental Treatments

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  • Busulfan is a chemotherapy cancer medication that interferes with the growth and spread of cancer cells in the body, and may be used in the treatment of many different cancers.
  • Cladribine is a chemotherapy medication approved for use in hairy cell leukemia, B-cell chronic lymphocytic leukemia, and multiple sclerosis. 
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Thiotepa is an antineoplastic chemotherapy agent that is used to treat several different kinds of cancer.
  • Venetoclax is a BCL-2 inhibitor that may work by blocking the action of the BCL-2 protein on some cancer cells which can lead to cell death. 

Arms / Cohorts

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Accepting patients

Venetoclax + Busulfan + Fludarabine + Cladribine

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