Clinical Trials Search
Clinical Trial 19143
Cancer Type: Malignant Hematology
Interventions:ATG; Alkeran (Melphalan); FK506 (Tacrolimus); MESNA; Melphalan; Tacrolimus; busulfan; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate); methotrexate
Study Type: Prevention
Phase of Study: Phase III
- Farhad Khimani
A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus Host-Disease
The purpose of this study is to compare three different combinations of treatment plans to see whether one or more of them are better than a standard transplant procedure. The procedures being studied have the objective to reduce the occurrence of chronic GVHD. The procedures included in this clinical trial are: Treatment Group A: CD34 Selected Peripheral Blood Stem Cell Transplant. Treatment Group B: Bone Marrow Transplant followed by Post-Transplant Cyclophosphamide. Treatment Group C: Bone Marrow Transplant with Tacrolimus and Methotrexate as GVHD Prevention.
The Primary Objective of the randomized trial is to compare chronic GVHD/relapse-free survival [CRFS] as a time to event endpoint after hematopoietic stem cell transplant (HSCT) between each of the CNI-free interventions and a Tac/Mtx control. Secondary Objectives are: Comparison of rates of grade II-IV and III-IV acute GVHD, chronic GVHD, chronic GVHD-free survival, immunosuppression-free survival at one year, neutrophil and platelet engraftment, disease relapse, transplant related mortality, rates of Grade >/= 3 toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0; incidence of CMV and EBV reactivation, incidence of infections; immune reconstitution, quality of life and overall survival.