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

Launched by UNIVERSITY OF BRITISH COLUMBIA · Jan 11, 2023

Keywords

ClinConnect Summary

The ABLE3.0/CTTC2201 clinical trial is studying a condition called chronic graft-versus-host disease (cGvHD), which can occur after a bone marrow transplant (BMT). In cGvHD, the donor's immune cells can mistakenly attack the recipient's body, leading to serious health problems and a lower quality of life. This trial aims to find out if certain biological markers (called biomarkers) can help doctors predict which patients are most likely to develop cGvHD before they actually get it. This information could help doctors adjust treatments early on, either by reducing medications for low-risk patients or considering more aggressive treatments for those at higher risk.

To be eligible for this study, participants must be over 18 years old and have undergone a type of stem cell transplant for various reasons, including leukemia or other blood disorders. The trial is currently recruiting participants, and those who join can expect to be closely monitored for up to a year after their transplant to see if they develop cGvHD. This research could lead to better treatment strategies for patients at risk, ultimately improving their health outcomes after a transplant.

Gender

ALL

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).