Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Nebraska
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Attenuated-dose Cyclophosphamide
- High-dose Cyclophosphamide
- Sirolimus
- Mycophenolate Mofetil (MMF)
Treatment groups
126 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov