126
Participants
Start Date
June 23, 2025
Primary Completion Date
April 30, 2031
Study Completion Date
November 30, 2031
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.
RECRUITING
University of Nebraska Medical Center, Omaha
University of Nebraska
OTHER