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NCT04708054 · ClinicalTrials.gov record · last posted 2026-08-11

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

StatusRecruiting
PhasePhase 2/3
Started2021-10-21
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 23 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 23 times since 2021-01-12; most recent amendment 2026-02-17. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-05-28
Status change Active, Not Recruiting→Recruitingv13
2024-02-08
Status change Recruiting→Active, Not Recruitingv11
2021-12-28
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT04708054
Lead Sponsor M.D. Anderson Cancer Center
Conditions Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome
Enrollment 324 participants
Start Date 2021-10-21
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11