Phase II Study Comparing Two Reduced-Intensity Conditioning Regimens for Allogeneic Stem Cell Transplant in Blood Cancers

What this Trial Is About

Researchers are evaluating two conditioning regimens, FM-PTCy and FM-ATG, in patients undergoing allogeneic hematopoietic cell transplantation with HLA-matched donors. The study aims to improve the 2-year current GVHD-free, relapse-free survival cGRFS rate from 30% to 45%. This is a phase II, multicenter, randomized, open-label trial with 114 patients, including a 3-year recruitment period and long-term follow-up extending up to 18 years to monitor outcomes like GVHD status, disease progression, second malignancies, and quality of life. Participants will be randomly assigned to one of two treatment groups FM-PTCy or FM-ATG. The FM-PTCy group receives intravenous fludarabine on days -6 to -2, melphalan on day -2, and cyclophosphamide on days 3 and 4. The FM-ATG group receives the same fludarabine and melphalan schedule but replaces cyclophosphamide with ATG Thymoglobulin on days -2 and -1. Both regimens are reduced-intensity conditioning treatments before transplantation. During the study, participants will undergo regular assessments including monitoring for GVHD, relapse, survival rates, and other health outcomes over 15 years and beyond. Evaluations include relapse rates, acute and chronic GVHD rates, non-relapse mortality, leukemia-free survival, overall survival, and quality of life. Long-term follow-up up to 18 years will track disease status and potential late effects. This extensive monitoring aims to provide comprehensive data on the effectiveness and safety of the two conditioning regimens.

Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning