Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT06799195
Phase
PHASE2
Status
Recruiting
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Conditions

  • Graft-versus-Host Disease (GVHD)
  • Hematological Malignancies

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Attenuated-dose Cyclophosphamide — DRUG
    Cyclophosphamide administered at an attenuated dose of 25 mg/kg on days +3 and +4 post-transplant for GVHD prophylaxis.
  • High-dose Cyclophosphamide — DRUG
    Cyclophosphamide administered at the standard high dose of 50 mg/kg on days +3 and +4 post-transplant for GVHD prophylaxis.
  • Sirolimus — DRUG
    Sirolimus is started on day +5 with a loading dose of 6 mg, followed by a maintenance dose of 2 mg daily, adjusted to target trough levels of 8-12 ng/mL. Sirolimus taper is recommended to start at day +90 and to be completed by day +180, provided there is no evidence of acute GVHD.
  • Mycophenolate Mofetil (MMF) — DRUG
    MMF is started on day +5 at a dose of 15 mg/kg per dose (maximum 1 g per dose) three times daily. MMF is generally discontinued by day +35 in the absence of GVHD.

Study Details

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 Dates

Start date
Jun 23, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2031
Completion
Nov 30, 2031

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Attenuated-dose post-transplant cyclophosphamide (PTCy) Arm
    Participants will receive attenuated-dose post-transplant cyclophosphamide (PTCy) at 25 mg/kg on days +3 and +4 after allogeneic hematopoietic stem cell transplantation. This is in addition to sirolimus and mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis.
  • Active Comparator: High-dose post-transplant cyclophosphamide (PTCy) Arm: Standard of Care
    Participants will receive high-dose post-transplant cyclophosphamide (PTCy) at 50 mg/kg on days +3 and +4 after allogeneic hematopoietic stem cell transplantation. This is in addition to sirolimus and mycophenolate mofetil (MMF) for GVHD prophylaxis.

Primary Outcome Measure

Change in Health-Related Quality of Life as Measured by Functional Assessment of Cancer Therapy-Bone Marrow Transplantation [ Time Frame: Baseline and 3 months post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
Taylor Johnson
[email protected]
402-559-4596
A
Moataz Ellithi, MBChB (PRINCIPAL_INVESTIGATOR)

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By research site
University of Nebraska Medical Center· Omaha, NE

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