drugset / Trial / NCT03192397

Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant

NCT03192397

Phase 1/2 Active not recruiting 35 enrolled Roswell Park Cancer Institute
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This phase Ib/2 trial studies how well chemotherapy, total body irradiation, and post-transplant cyclophosphamide work in reducing rates of graft versus host disease in patients with hematologic malignancies undergoing a donor stem cell transplant. Drugs used in the chemotherapy, such as fludarabine phosphate and melphalan hydrochloride, 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 stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a 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 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.

Timeline

Start
2017-08-09
Primary completion
2023-08-21
Completion
2027-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule 0.75 mg/m2 Intravenous
Subject Melphalan Small molecule 25 mg/m2 Intravenous
Subject Melphalan Small molecule 50 mg/m2 Intravenous
Subject Melphalan Small molecule 75 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Fludarabine Small molecule 40 mg/m2 Intravenous
Background Mycophenolate Mofetil Small molecule Intravenous
Background Sirolimus Small molecule Intravenous