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Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
Sponsor: University of Nebraska
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.
Official title: A Phase II Randomized Trial to Optimize GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Older Adults With Hematological Malignancies: the PROMISE Trial
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2025-06-23
Completion Date
2031-11
Last Updated
2025-12-15
Healthy Volunteers
No
Interventions
Attenuated-dose Cyclophosphamide
Cyclophosphamide administered at an attenuated dose of 25 mg/kg on days +3 and +4 post-transplant for GVHD prophylaxis.
High-dose Cyclophosphamide
Cyclophosphamide administered at the standard high dose of 50 mg/kg on days +3 and +4 post-transplant for GVHD prophylaxis.
Sirolimus
Sirolimus is started on day +5 with a loading dose of 6 mg, followed by a maintenance dose of 2 mg daily, adjusted to target trough levels of 8-12 ng/mL. Sirolimus taper is recommended to start at day +90 and to be completed by day +180, provided there is no evidence of acute GVHD.
Mycophenolate Mofetil (MMF)
MMF is started on day +5 at a dose of 15 mg/kg per dose (maximum 1 g per dose) three times daily. MMF is generally discontinued by day +35 in the absence of GVHD.
Locations (1)
University of Nebraska Medical Center
Omaha, Nebraska, United States