Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
Start Date
6/23/2025
Completion Date
11/1/2031
Summary
This study will compare post-transplant health-related quality of life following the use of standard versus attenuated dose of post-transplant cyclophosphamide in addition to two-drug graft-versus-host disease (GVHD) prophylaxis among recipients of allogeneic hematopoietic stem cell transplant.
Detailed Description
This is a single-center phase II study of 126 participants (63 per arm) with hematological malignancies. Participants will be randomized to receive high doses (standard arm) or attenuated doses of cyclophosphamide in addition to two-drug GVHD prophylaxis. Participants will be monitored for health-related quality of life \[Functional Assessment of Cancer Therapy-Bone Marrow Transplant, FACT-BMT(1)\], functional outcomes (Karnofsky Performance Scale (KPS), activities of daily living, instrumental activities of daily living, Clock-in-the-Box Test, Fried Frailty Index, fall history, BMI, and Geriatric Depression Scale-15, GVHD, relapse, survival, and toxicities (using Common Terminology Criteria for Adverse Events, CTCAE version 5.0).
Eligibility Criteria
Age Range: 60 years to No maximum
Interventions
Attenuated-dose Cyclophosphamide
High-dose Cyclophosphamide
Sirolimus
Mycophenolate Mofetil (MMF)
Conditions
Locations
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States