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

Status unconfirmed

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

In brief

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).

Key facts

Study ID

NCT05692713

Run by

University of British Columbia

People needed

320

Starts

2023-07-01

Expected to finish

2025-06-30

Last updated by the study team

2023-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• UHN Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Washington University St. Louis — St Louis, Missouri, United States (enrolling)
• LHSC: Victoria Hospital — London, Ontario, Canada
• CHU de Québec - Université Laval — Laval, Quebec, Canada
• McGill University Health Center — Montreal, Quebec, Canada
• CancerCare Manitoba — Winnipeg, Manitoba, Canada
• NS Health — Halifax, Nova Scotia, Canada
• Juravinski Hospital & Cancer Centre — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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