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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

Biomarker Verification in Pediatric Chronic Graft-Versus-Host Disease: Applied Biomarkers to Minimize Long Term Effects of Childhood/Adolescent Cancer Treatment (ABLE) / Pediatric Transplantation & Cellular Therapy Consortium (PTCTC)

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

Condition
Chronic Graft-versus-Host-Disease
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California San Francisco, San Francisco, California, United States, 94158

Denver

Children's Hospital Colorado, Denver, Colorado, United States, 80045

Atlanta

Emory University School of Medicine, Atlanta, Georgia, United States, 30322

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Buffalo

Roswell Park Comprehensive Care Center, Buffalo, New York, United States, 14263

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10174

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27599

Charlotte

Atrium Health Levine Cancer Institute, Charlotte, North Carolina, United States, 28203

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205-2664

Portland

Oregon Health & Science University Knight Cancer Institute, Portland, Oregon, United States, 97239-3098

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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).

Ages Eligible for Study

0 Years to 24 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of British Columbia,

Kirk R Schultz, MD, PRINCIPAL_INVESTIGATOR, University of British Columbia / BC Children's Hospital Research Institute

Andrew C Harris, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center / Pediatric Stem Cell Transplantation and Cellular Therapies

Study Record Dates

2025-01