Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
Recruiting now · Phase 2
Conditions studied: Hematological Malignancies, Graft-versus-Host Disease (GVHD)
In brief
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.
Key facts
- Study ID
- NCT06799195
- Run by
- University of Nebraska
- People needed
- 126
- Starts
- 2025-06-23
- Expected to finish
- 2031-11-01
- Last updated by the study team
- 2025-12-15
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
Full record on ClinicalTrials.gov
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