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)
Status: Recruiting
Location: See all (16) locations...
Study Type: Observational
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 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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 24
Healthy Volunteers: f
View:
• 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
Locations
United States
California
University of California San Francisco
RECRUITING
San Francisco
Colorado
Children's Hospital Colorado
RECRUITING
Denver
Georgia
Emory University School of Medicine
NOT_YET_RECRUITING
Atlanta
Missouri
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
North Carolina
University of North Carolina
NOT_YET_RECRUITING
Chapel Hill
Atrium Health Levine Cancer Institute
RECRUITING
Charlotte
New York
Roswell Park Comprehensive Care Center
RECRUITING
Buffalo
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Oregon
Oregon Health & Science University Knight Cancer Institute
RECRUITING
Portland
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Other Locations
Canada
Alberta Children's Hospital
RECRUITING
Calgary
CHU Sainte-Justine
RECRUITING
Montreal
McGill University Health Centre
RECRUITING
Montreal
BC Children's Hospital
RECRUITING
Vancouver
CancerCare Manitoba
ACTIVE_NOT_RECRUITING
Winnipeg
Contact Information
Primary
Elena Ostroumov, PhD
Elena.Ostroumov@bcchr.ca
604-875-2000
Backup
Sayeh Abdossamadi, PhD
sabdossamadi@bcchr.ca
604-875-2454
Time Frame
Start Date:2020-11-15
Estimated Completion Date:2025-01
Participants
Target number of participants:350
Treatments
Allogeneic HSC Transplant recipients
Five possible patient scenarios are anticipated to occur in those who underwent allogeneic HSCT:~* Early event (e.g. death, non-engraftment) occurring before day 100.~* No late-acute or chronic GvHD ever develops at any time point in the first year post-transplant (regardless of whether or not classical acute GvHD develops in the first 100 days after transplant).~* Early-onset chronic GvHD (including overlap syndrome) occurred before day 60.~* Early-onset chronic GvHD (including overlap syndrome) occurred between day 60 and day 100.~* Chronic GvHD after Day 100, Late-acute GvHD (de-novo or recurrent) after day 100, or cases of overlap syndrome occurred after day 100.