HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post … (NCT06001385) | Clinical Trial Compass
Active — Not RecruitingPhase 2
HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis
United States313 participantsStarted 2023-12-08
Plain-language summary
The goal of this clinical trial is to determine the effectiveness of Reduced Dose Post-Transplant Cyclophosphamide (PTCy) in patients with hematologic malignancies after receiving an HLA-Mismatched Unrelated Donor (MMUD) . The main question\[s\] it aims to answer are:
* Does a reduced dose of PTCy reduce the occurrence of infections in the first 100 days after transplant?
* Does a reduced dose of PTCy maintain the same level of protection against Graft Versus Host Disease (GvHD) as the standard dose of PTCy?
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years and \< 66 years (chemotherapy-based conditioning) or \< 61 years (total body irradiation \[TBI\]-based conditioning) at the time of signing informed consent
✓. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional requirements.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Planned MAC regimen as defined per study protocol
✓. Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age ≥ 18 and ≤ 40 years (≤ 35 preferred).
✓. Product planned for infusion is MMUD T-cell replete PBSC allograft
✓. HCT-CI \< 5. The presence of prior malignancy will not be used to calculate HCT-CI for this trial to allow for the inclusion of patients with secondary or therapy-related AML or MDS.
✓. One of the following diagnoses:
Exclusion criteria
What they're measuring
1
Infection Free Survival
Timeframe: 100 days post-HCT
Trial details
NCT IDNCT06001385
SponsorCenter for International Blood and Marrow Transplant Research