Study on Preventing Graft-Versus-Host Disease in Patients Receiving Stem Cell Transplants from Unrelated Donors
Sponsor: Center for International Blood and Marrow Transplant Research
ClinicalTrials ID:NCT06859424
This clinical trial is testing different drug combinations to find the best way to prevent graft-versus-host disease (GVHD) in patients who have received a stem cell transplant from an unrelated donor with a different blood type.
Patient Parameters
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Program Overview
The goal of this study is to compare different drug combinations to see which is most effective at preventing graft-versus-host disease (GVHD) in patients who have received a stem cell transplant from an unrelated donor with a different blood type. Researchers will compare a new drug combination to a standard one and assess the safety of each. Participants will receive either the standard or new drug combination after their transplant, attend regular check-ups and tests, complete surveys about their well-being, and provide blood and stool samples.
Description
This study is designed to evaluate the safety and effectiveness of using cyclophosphamide-based treatments to prevent graft-versus-host disease (GVHD) after a stem cell transplant from an unrelated donor with a different blood type. Patients with blood cancers who meet the study criteria and receive stem cells from a mismatched donor will be eligible to participate. The study will compare different treatment approaches to find the best way to prevent GVHD.
The study includes two specific treatment plans, called ACCEL-001 and ACCEL-002, which will be tested against a standard treatment. These plans detail the specific treatments, target patient groups, and methods for evaluating the results. Additional treatment plans may be added or removed during the study.
Eligibility Criteria
Exclusion Criteria
- Have a suitable donor who is a perfect match or an 8/8 high-resolution match.
- Unable or unwilling to give informed consent or follow the study requirements.
- Have had a previous allogeneic transplant.
- Have had an autologous transplant within the last 3 months.
- Are pregnant or breastfeeding.
- Have an uncontrolled infection at the time of transplant preparation.
- Are enrolled in another GVHD prevention study.
- Undergo desensitization to lower anti-donor antibody levels before transplant.
- Are HIV-positive with a detectable viral load. Patients with well-controlled HIV on effective treatment and an undetectable viral load are eligible.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford | 94304 | Palo Alto | California |
| MD Anderson | 77030 | Houston | Texas |
| University of Virginia | 22903 | Charlottesville | Virginia |
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