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Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
A Phase II Randomized Trial to Optimize GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Older Adults With Hematological Malignancies: the PROMISE Trial
Who can join
Ages 60 and older · All sexes
Full eligibility criteria
Inclusion criteria: * 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. Exclusion criteria: * Previous history of one or more prior allogeneic stem cell transplants (i.e., second or third allogeneic transplant) * Planned use of high doses of cyclophosphamide (e.g., a total cyclophosphamide dose of approximately 50 mg/kg or more) as part of the conditioning regimen prior to allogeneic stem cell transplant. A lower dose of cyclophosphamide (e.g., fludarabine, cyclophosphamide, and low-dose total body irradiation regimen that uses 2 doses of cyclophosphamide at 14.5 mg/kg) is acceptable. * Known diagnosis of liver cirrhosis or other advanced liver disease that may impact cyclophosphamide metabolism. * Diagnosis of myelofibrosis * Creatinine clearance less than 40 mL/min/1.73 m², which may increase the risk of hemorrhagic cystitis with post-transplant cyclophosphamide (PTCy) * Systolic cardiac dysfunction with an ejection fraction of less than 45%. * Use of a haploidentical or mismatched donor. * Any other condition judged by the physician to increase the risk of toxicities associated with PTCy.
About the study
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.
What is being tested
- Attenuated-dose Cyclophosphamide (drug)
- High-dose Cyclophosphamide (drug)
- Sirolimus (drug)
- Mycophenolate Mofetil (MMF) (drug)
Sponsor: University of Nebraska · Participants: 126 · Started: Jun 23, 2025
Contact the study team
- Taylor Johnson · Phone: 402-559-4596
- IIT OFFICE · Phone: 402-559-4596
Official record on ClinicalTrials.gov — NCT06799195
Locations in the U.S.
| Nebraska | University of Nebraska Medical Center, Omaha |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.