A Phase II Randomized Trial to Optimize GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Older Adults With Hematological Malignancies: the PROMISE Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• Adults aged 60 years or older
• Diagnosis of a hematological malignancy or other serious hematological disorder that requires an allogeneic hematopoietic cell transplantation
• Planned to receive any reduced-intensity conditioning regimen (any graft source is acceptable) and availability of human leukocyte antigen (HLA)-matched donor at HLA loci A, B, C, and HLA-DR beta chain antigen (DRB1)
• Karnofsky Performance Status (KPS) of 70% or higher.
Locations
United States
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Contact Information
Primary
Vijaya R Bhatt, MBBS
vijaya.bhatt@unmc.edu
402-559-8008
Backup
Rubayat I Khan, PhD
rubayat.khan@unmc.edu
402-559-2983
Time Frame
Start Date: 2025-06-23
Estimated Completion Date: 2031-11
Participants
Target number of participants: 126
Treatments
Experimental: Attenuated-dose post-transplant cyclophosphamide (PTCy) Arm
Participants will receive attenuated-dose post-transplant cyclophosphamide (PTCy) at 25 mg/kg on days +3 and +4 after allogeneic hematopoietic stem cell transplantation. This is in addition to sirolimus and mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis.
Active_comparator: High-dose post-transplant cyclophosphamide (PTCy) Arm: Standard of Care
Participants will receive high-dose post-transplant cyclophosphamide (PTCy) at 50 mg/kg on days +3 and +4 after allogeneic hematopoietic stem cell transplantation. This is in addition to sirolimus and mycophenolate mofetil (MMF) for GVHD prophylaxis.
Related Therapeutic Areas
Sponsors
Leads: University of Nebraska