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Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Sponsor: M.D. Anderson Cancer Center
Summary
This randomized phase II trial studies how well venetoclax and sequential busulfan, cladribine, and fludarabine phosphate before donor stem cell transplant work in treating patients with acute myelogenous leukemia or myelodysplastic syndrome. Giving chemotherapy before a donor peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells.
Official title: Allogeneic Transplantation Using Venetoclax, Timed Sequential Busulfan,Cladribine, and Fludarabine Conditioning in Patients With AML and MDS
Key Details
Gender
All
Age Range
2 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2014-10-27
Completion Date
2027-10-31
Last Updated
2025-10-06
Healthy Volunteers
No
Interventions
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic PBSCT
Busulfan
Given IV
Cladribine
Given IV
Fludarabine Phosphate
Given IV
Laboratory Biomarker Analysis
Correlative studies
Peripheral Blood Stem Cell Transplantation
Undergo allogeneic PBSCT
Pharmacological Study
Correlative studies
Venetoclax
Given PO
Locations (1)
M D Anderson Cancer Center
Houston, Texas, United States