Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 5, 2023 · Source: ClinicalTrials.gov
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Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- University of British Columbia
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
1. Any indication for allogeneic hematopoietic stem cell transplant (malignant or non-malignant) 2. Age 0 - 24.99 years at the time of transplant (on day 0) 3. Any conditioning regimen (including myeloablative or reduced-toxicity/reduced-intensity) 4. Any graft source (bone marrow, peripheral blood, cord blood) 5. Any graft-versus-host disease prophylaxis strategy, including serotherapy such as ATG or alemtuzumab 6. Haploidentical transplants, including post-transplant cyclophosphamide and alpha-beta TCR depletion, are allowed
1. Second or greater allogeneic transplant 2. Weight 7 kg or less 3. Pure CD34+ selected haploidentical stem cell transplant (not including CD34 enrichment used in alpha-beta TCR depleted haploidentical transplants, which is allowed) 4. 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).
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of California San FranciscoSan Francisco, California
- Children's Hospital ColoradoDenver, Colorado
- Emory University School of MedicineAtlanta, Georgia
- Washington University School of MedicineSt Louis, Missouri
- Roswell Park Comprehensive Care CenterBuffalo, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
- University of North CarolinaChapel Hill, North Carolina
- Atrium Health Levine Cancer InstituteCharlotte, North Carolina
- Nationwide Children's HospitalColumbus, Ohio
- Oregon Health & Science University Knight Cancer InstitutePortland, Oregon
- Vanderbilt University Medical CenterNashville, Tennessee
- Alberta Children's HospitalCalgary, Alberta
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 5, 2023. Always confirm current availability with the study team.