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Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease (ABLE3.0/CTTC2201)

Leukemia | Allogeneic Hematopoietic Stem Cell Transplantation | Chronic Graft-versus-host-disease | Blood...

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).

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

INCLUSION CRITERIA:

1. Any indication for allogeneic hematopoietic stem cell transplant (malignant and nonmalignant);
2. Age \>18 years (those who reached the age of majority) 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 GvHD prophylaxis strategy, including serotherapy such as ATG or alemtuzumab;
6. Haploidentical transplants, including post-transplant cyclophosphamide and alpha-beta TCR depletion, are allowed

EXCLUSION CRITERIA:

1. Age \< 18 years (or under the age of majority) at the time of consent;
2. Second or greater allogeneic transplant;
3. Pure CD34+ selected stem cell grafts (not including C34+ cell enrichment used in alpha-beta TCR depleted haploidentical grafts, which are 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).

Study Location

CancerCare Manitoba
CancerCare Manitoba
Winnipeg, Manitoba
Canada

Contact Study Team

Primary Contact

Kristjan Paulson, MD

UHN Princess Margaret Cancer Centre
UHN Princess Margaret Cancer Centre
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Frank Michelis, MD, PhD

LHSC: Victoria Hospital
LHSC: Victoria Hospital
London, Ontario
Canada

Contact Study Team

Primary Contact

Uday Deotare, MD

Juravinski Hospital & Cancer Centre
Juravinski Hospital & Cancer Centre
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Kylie Lepic, MD

McGill University Health Center
McGill University Health Center
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Gizelle Popradi, MDCM

NS Health
NS Health
Halifax, Nova Scotia
Canada

Contact Study Team

Primary Contact

Mahmoud Elsawy, MD, MSc

CHU de Québec - Université Laval
CHU de Québec - Université Laval
Laval, Quebec
Canada

Contact Study Team

Primary Contact

Geneviève Gallagher, MD

Study Sponsored By
University of British Columbia
Participants Required
More Information
Study ID: NCT05692713