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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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (16 locations)

    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