Phase II Study Comparing Standard and Lower Doses of Cyclophosphamide for GVHD Prevention After Stem Cell Transplant in Older Adults with Blood Cancers

What this Trial Is About

Researchers are investigating the effects of different doses of post-transplant cyclophosphamide on health-related quality of life in older adults undergoing allogeneic hematopoietic stem cell transplantation for hematological malignancies. This phase II study compares a standard high dose with a lower, attenuated dose, both combined with two-drug graft-versus-host disease GVHD prevention. The goal is to understand how these regimens impact patients recovery and wellbeing after transplant. Participants are randomly assigned to receive either high-dose cyclophosphamide 50 mgkg or attenuated-dose cyclophosphamide 25 mgkg on days 3 and 4 after transplant. Both groups also receive sirolimus and mycophenolate mofetil MMF starting on day 5 for GVHD prevention, with sirolimus dosing adjusted over time and MMF typically stopped by day 35 if no GVHD occurs. The study involves 126 participants, split evenly between the two treatment plans. During the study, participants will be closely monitored for changes in quality of life using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant FACT-BMT tool, as well as functional status, physical abilities, frailty, depression, and GVHD symptoms. Researchers will track survival, relapse, toxicities, and complications for up to one year post-transplant. Assessments include clinical scales, physical tests, and medical evaluations to understand the effects of each treatment approach on recovery and health outcomes.

Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation