RECRUITING

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

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Conditions

Chronic Graft-versus-Host-DiseaseLeukemiaAllogeneic Hematopoietic Stem Cell TransplantationBlood CancerNon-Malignant Hematologic and Lymphocytic DisordercGvHDHSCTL-aGvHDBiomarkersBloodPediatricAdolescentHematopoietic Stem Cell TransplantLate acute Graft-versus-Host Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2020-11-15
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04372524

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.

Ages Eligible for Study:0 Years to 24 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Any indication for allogeneic hematopoietic stem cell transplant (malignant or non-malignant)
  2. 2. Age 0 - 24.99 years at the time of transplant (on day 0)
  3. 3. Any conditioning regimen (including myeloablative or reduced-toxicity/reduced-intensity)
  4. 4. Any graft source (bone marrow, peripheral blood, cord blood)
  5. 5. Any graft-versus-host disease prophylaxis strategy, including serotherapy such as ATG or alemtuzumab
  6. 6. Haploidentical transplants, including post-transplant cyclophosphamide and alpha-beta TCR depletion, are allowed
  1. 1. Second or greater allogeneic transplant
  2. 2. Weight 7 kg or less
  3. 3. Pure CD34+ selected haploidentical stem cell transplant (not including CD34 enrichment used in alpha-beta TCR depleted haploidentical transplants, which is allowed)
  4. 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).

Contacts and Locations

Study Contact

Elena Ostroumov, PhD
CONTACT
604-875-2000
Elena.Ostroumov@bcchr.ca
Sayeh Abdossamadi, PhD
CONTACT
604-875-2454
sabdossamadi@bcchr.ca

Principal Investigator

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 Locations (Sites)

University of California San Francisco
San Francisco, California, 94158
United States
Children's Hospital Colorado
Denver, Colorado, 80045
United States
Emory University School of Medicine
Atlanta, Georgia, 30322
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Roswell Park Comprehensive Care Center
Buffalo, New York, 14263
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10174
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28203
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205-2664
United States
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, 97239-3098
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6311
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-15
Study Completion Date2025-01

Study Record Updates

Study Start Date2020-11-15
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • cGvHD
  • HSCT
  • L-aGvHD
  • Biomarkers
  • Blood
  • Pediatric
  • Adolescent
  • Chronic Graft-versus-Host-Disease
  • Hematopoietic Stem Cell Transplant
  • Late acute Graft-versus-Host Disease

Additional Relevant MeSH Terms

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