Improving GVHD prevention after donor stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized Phase 2 study will enroll 126 participants aged 60 and older with hematologic malignancies undergoing reduced-intensity allogeneic hematopoietic cell transplantation. Participants are randomized to receive either the standard high dose or an attenuated dose of post-transplant cyclophosphamide in addition to sirolimus and mycophenolate mofetil for GVHD prophylaxis. The trial will follow patients for health-related quality of life using FACT-BMT and a battery of functional measures (KPS, ADLs/IADLs, frailty measures, cognitive clock test, BMI, falls, GDS-15) as well as monitoring for acute and chronic GVHD, relapse, survival, and treatment toxicities using CTCAE v5.0. The primary focus is on post-transplant HRQoL and functional outcomes in an older transplant population.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting

Study contacts

• Principal investigator: Moataz Ellithi, MBChB — University of Nebraska
• Study coordinator: Taylor Johnson
• Email: taylora.johnson@unmc.edu
• Phone: 402-559-4596

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.