Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study (NCT04372524) | Clinical Trial Compass
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Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
United States350 participantsStarted 2020-11-15
Plain-language 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 children and young adults undergoing allogeneic hematopoietic stem cell transplant.
By developing an early risk stratification of patients into low-, intermediate-, and high-risk for future cGvHD development (based upon their biomarker profile, before the onset of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed based upon an individual's biological risk profile.
This study will also continue research into diagnostic biomarkers of cGvHD, and begin work into biomarker models that predict clinical response to cGvHD therapies.
Who can participate
Age range0 Years – 24 Years
SexALL
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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)
What they're measuring
1
Day 60 blood sample collection
Timeframe: Day 60 (+/- 7 days) post-transplant
2
Day 100 blood sample collection
Timeframe: Day 100 (+/- 14 days) post-transplant
3
Onset CvHD blood sample collection
Timeframe: The day of initial diagnosis
4
Baseline transplant clinical data collection at Day 0
Timeframe: Between day 0 (day of transplant) and day +21
. 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).