drugset / Trial / NCT02861417

Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant

NCT02861417

Phase 2 Active not recruiting 204 enrolled M.D. Anderson Cancer Center National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies the side effect of busulfan, fludarabine phosphate, and post-transplant cyclophosphamide in treating patients with blood cancer undergoing donor stem cell transplant. Drugs used in chemotherapy, such as busulfan, fludarabine phosphate and cyclophosphamide 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 such as busulfan and fludarabine phosphate before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them.

Timeline

Start
2016-08-05
Primary completion
2026-08-31
Completion
2026-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 80 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified Intravenous
Subject Fludarabine Small molecule 40 mg/m2 Intravenous
Subject Mycophenolate Mofetil Small molecule Oral
Subject Thiotepa Other / unclassified Intravenous
Background Tacrolimus Small molecule Intravenous