Status:
UNKNOWN
Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
Lead Sponsor:
University of British Columbia
Conditions:
Chronic Graft-versus-Host-Disease
Leukemia
Eligibility:
All Genders
Up to 24 years
Brief Summary
This study will validate a previously developed pediatric prognostic biomarker algorithm aimed at improving prediction of risk for the later development of chronic graft-versus-host disease (cGvHD) in...
Detailed Description
Chronic graft-versus-host disease (cGvHD) occurs when the new donor immune system "attacks" tissues in the recipient following allogeneic hematopoietic stem cell transplantation (HSCT), leading to chr...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Any indication for allogeneic hematopoietic stem cell transplant (malignant or non-malignant)
- Age 0 - 24.99 years at the time of transplant (on day 0)
- Any conditioning regimen (including myeloablative or reduced-toxicity/reduced-intensity)
- Any graft source (bone marrow, peripheral blood, cord blood)
- Any graft-versus-host disease prophylaxis strategy, including serotherapy such as ATG or alemtuzumab
- Haploidentical transplants, including post-transplant cyclophosphamide and alpha-beta TCR depletion, are allowed
- EXCLUSION CRITERIA:
- Second or greater allogeneic transplant
- Weight 7 kg or less
- Pure CD34+ selected haploidentical stem cell transplant (not including CD34 enrichment used in alpha-beta TCR depleted haploidentical transplants, which is allowed)
- Inability of a center to follow a patient for the development of late-acute and chronic GVHD until 1-year post-transplant (referral sites who transplant patients from outside institutions should not enroll participants if sending back to the referring site early, such that long-term follow up, blood, and data collection cannot be assured).
Exclusion
Key Trial Info
Start Date :
November 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04372524
Start Date
November 15 2020
End Date
January 1 2025
Last Update
December 5 2023
Active Locations (16)
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1
University of California San Francisco
San Francisco, California, United States, 94158
2
Children's Hospital Colorado
Denver, Colorado, United States, 80045
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110