Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease. Applied Biomarkers in Late Effects (ABLE) (ABLE3.0/CTTC2201)

Status: Recruiting
Location: See all (10) locations...
Study Type: Observational
SUMMARY

Chronic graft-versus-host disease (cGvHD) is one of the most serious complications following BMT (Bone Marrow Transplantation). cGvHD occurs when donor immune cells attack the tissues and organs of the person receiving the BMT. cGvHD can be difficult to treat once it is established leading to poor quality of life for recipients of a BMT. The goal of this study is to determine if, by using biomarkers, the investigators can predict which patients are at the highest risk of developing cGvHD after BMT, before cGvHD develops. The ABLE3.0 / CTTC 2201 study will validate and potentially refine the initial predictive biomarker algorithm developed from the original ABLE/PBTMC 1202 study (ABLE1.0), allowing clinicians the ability to pre-emptively predict their patient's future risk of developing both late-acute and chronic GvHD. This will provide the foundation for the later development of clinical trials aimed at reducing immune suppression quicker after transplant for low-risk patients (\<10% risk) and justifying more intensive approaches such as pre-emptive treatments before the onset of chronic GvHD in high-risk patients (\>45% risk).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Any indication for allogeneic hematopoietic stem cell transplant (malignant and nonmalignant);

• Age \>18 years (those who reached the age of majority) 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 GvHD 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
Missouri
Washington University St. Louis
RECRUITING
St Louis
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Oregon
Oregon Health & Science University
RECRUITING
Portland
Other Locations
Canada
NS Health
NOT_YET_RECRUITING
Halifax
Juravinski Hospital & Cancer Centre
NOT_YET_RECRUITING
Hamilton
CHU de Québec - Université Laval
NOT_YET_RECRUITING
Laval
LHSC: Victoria Hospital
NOT_YET_RECRUITING
London
McGill University Health Center
NOT_YET_RECRUITING
Montreal
UHN Princess Margaret Cancer Centre
RECRUITING
Toronto
CancerCare Manitoba
NOT_YET_RECRUITING
Winnipeg
Contact Information
Primary
Elena Ostroumov, PhD
elena.ostroumov@bcchr.ca
604-875-2000
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 320
Sponsors
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov