๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 mยฒ, 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.
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What it tests
- Attenuated-dose Cyclophosphamide
- High-dose Cyclophosphamide
- Sirolimus
- Mycophenolate Mofetil (MMF)
University of Nebraska Medical Center
Omaha, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.