drugset / Trial / NCT04708054

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

NCT04708054

Phase 2/3 Recruiting 324 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-10-21
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule Intravenous
Subject Cladribine Small molecule Intravenous
Subject Fludarabine Small molecule Intravenous
Subject Venetoclax Small molecule Oral
Background Thiotepa Other / unclassified Intravenous