Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

PHASE2RecruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

June 23, 2025

Primary Completion Date

April 30, 2031

Study Completion Date

November 30, 2031

Conditions
Hematological MalignanciesGraft-versus-Host Disease (GVHD)
Interventions
DRUG

Attenuated-dose Cyclophosphamide

Cyclophosphamide administered at an attenuated dose of 25 mg/kg on days +3 and +4 post-transplant for GVHD prophylaxis.

DRUG

High-dose Cyclophosphamide

Cyclophosphamide administered at the standard high dose of 50 mg/kg on days +3 and +4 post-transplant for GVHD prophylaxis.

DRUG

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.

DRUG

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.

Trial Locations (1)

68198

RECRUITING

University of Nebraska Medical Center, Omaha

All Listed Sponsors
lead

University of Nebraska

OTHER