Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease (ABLE3.0/CTTC2201)
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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 8, 2023 · Source: ClinicalTrials.gov
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Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- University of British Columbia
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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
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).
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Washington University St. LouisSt Louis, Missouri
- University of Nebraska Medical CenterOmaha, Nebraska
- Oregon Health & Science UniversityPortland, Oregon
- CancerCare ManitobaWinnipeg, Manitoba
- NS HealthHalifax, Nova Scotia
- Juravinski Hospital & Cancer CentreHamilton, Ontario
- LHSC: Victoria HospitalLondon, Ontario
- UHN Princess Margaret Cancer CentreToronto, Ontario
- CHU de Québec - Université LavalLaval, Quebec
- McGill University Health CenterMontreal, Quebec
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 8, 2023. Always confirm current availability with the study team.