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

Leukemia | Allogeneic Hematopoietic Stem Cell Transplantation | Chronic Graft-versus-host-disease | Blood...

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    0 to 24

Participation Criteria

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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).

Study Location

Alberta Children's Hospital
Alberta Children's Hospital
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Debra Rich

[email protected]
McGill University Health Centre
McGill University Health Centre
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Samira Mezziani

[email protected]
CHU Sainte-Justine
CHU Sainte-Justine
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

David Godin

[email protected]
BC Children's Hospital
BC Children's Hospital
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Alecia Lim

[email protected]
CancerCare Manitoba
CancerCare Manitoba
Winnipeg, Manitoba
Canada

Contact Study Team

Study Sponsored By
University of British Columbia
Participants Required
More Information
Study ID: NCT04372524