Predicting risk of chronic graft-versus-host disease after bone marrow transplantation

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

This study is trying to find a way to predict which adult patients who receive a bone marrow transplant might develop chronic graft-versus-host disease, so doctors can help them earlier and improve their outcomes.

Quick facts

• Study type: Observational
• Enrollment: 320 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of British Columbia (other)
• Drugs / interventions: alemtuzumab, cyclophosphamide
• Locations: 10 sites (Saint Louis, Missouri and 9 other locations)
• Trial ID: NCT05692713 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate and refine a predictive biomarker algorithm for chronic graft-versus-host disease (cGvHD) in adult patients undergoing allogeneic hematopoietic stem cell transplantation. By enrolling 320 transplant recipients, the study will collect blood samples and clinical data at various time points to identify patients at high risk for developing cGvHD. The goal is to enable clinicians to predict cGvHD risk before it develops, potentially leading to earlier interventions and improved patient outcomes. The findings will also lay the groundwork for future clinical trials focused on reducing immune suppression in low-risk patients.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who are undergoing allogeneic hematopoietic stem cell transplantation for blood cancers or other indications.

Not a fit: Patients under 18 years old or those receiving a second allogeneic transplant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prediction and management of cGvHD, enhancing the quality of life for patients post-transplant.

How similar studies have performed: Previous studies have shown promise in using biomarkers for predicting cGvHD, making this approach both relevant and potentially impactful.

Eligibility 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).

Where this trial is running

Saint Louis, Missouri and 9 other locations

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

Study contacts

• Principal investigator: Kirk R. Schultz, MD — University of British Columbia / BC Children's Hospital
• Study coordinator: Elena Ostroumov, PhD

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