drugset / Trial / NCT01529827

Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

NCT01529827 ↗

Phase 2 Completed 94 enrolled Roswell Park Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cell from a donor can make an immune response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and methotrexate after transplant may stop this from happening

Timeline

Start
2012-02-28
Primary completion
2015-05-28
Completion
2019-08-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Fludarabine Small molecule — Intravenous
Subject Melphalan Small molecule — Intravenous
Background Methotrexate Small molecule — Intravenous
Background Mycophenolate Mofetil Small molecule — Intravenous
Background Tacrolimus Small molecule — Intravenous