drugset / Trial / NCT04994808

Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia

NCT04994808

Phase 2 Active not recruiting 23 enrolled Fred Hutchinson Cancer Center Medexus Pharma, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trials studies the effect of treosulfan-based versus clofarabine-based conditioning regimens before donor hematopoietic stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia. Chemotherapy drugs, such as treosulfan, fludarabine, and clofarabine, 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. Giving chemotherapy and total-body irradiation before a donor hematopoietic 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. This study may help doctors determine whether treosulfan-based or clofarabine-based conditioning regimen works better before donor hematopoietic stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia.

Timeline

Start
2023-08-11
Primary completion
2026-01-22
Completion
2026-07-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified Intravenous
Subject Fludarabine Small molecule Intravenous
Subject Treosulfan Small molecule Intravenous