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RECRUITING
NCT06799195
PHASE2

Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

Sponsor: University of Nebraska

View on ClinicalTrials.gov

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

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.

Locations (1)

University of Nebraska Medical Center

Omaha, Nebraska, United States