Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study

Status unconfirmed

Conditions studied: Chronic Graft-versus-Host-Disease, Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Blood Cancer, Non-Malignant Hematologic and Lymphocytic Disorder

In brief

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.

Key facts

Study ID

NCT04372524

Run by

University of British Columbia

People needed

350

Starts

2020-11-15

Expected to finish

2025-01-01

Last updated by the study team

2023-12-05

Who can join

Age: any, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• McGill University Health Centre — Montreal, Quebec, Canada (enrolling)
• Children's Hospital Colorado — Denver, Colorado, United States (enrolling)
• Alberta Children's Hospital — Calgary, Alberta, Canada (enrolling)
• BC Children's Hospital — Vancouver, British Columbia, Canada (enrolling)
• CHU Sainte-Justine — Montreal, Quebec, Canada (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Roswell Park Comprehensive Care Center — Buffalo, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Atrium Health Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• Oregon Health & Science University Knight Cancer Institute — Portland, Oregon, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Emory University School of Medicine — Atlanta, Georgia, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• CancerCare Manitoba — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

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