Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study

Launched by UNIVERSITY OF BRITISH COLUMBIA · Apr 29, 2020

Keywords

ClinConnect Summary

The ABLE 2.0 study is a clinical trial that aims to improve our understanding of chronic graft-versus-host disease (cGvHD), which can occur after a type of cancer treatment called allogeneic hematopoietic stem cell transplantation. This research focuses on validating a special test that helps predict whether children and young adults are at risk for developing cGvHD after their transplant. By examining specific biological markers in their blood before any symptoms appear, the study hopes to categorize patients into low, intermediate, or high risk for future cGvHD. This information could lead to better prevention strategies tailored to each patient’s needs.

To participate in the trial, candidates must be between 0 and 24 years old and scheduled to receive an allogeneic stem cell transplant for any reason, including blood cancers or other blood-related disorders. Participants will be monitored closely for up to a year after their transplant to track the development of cGvHD and how well treatments work. This study is currently recruiting eligible participants and aims to enhance the care and outcomes for young patients undergoing this important treatment.

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• • 1. Any indication for allogeneic hematopoietic stem cell transplant (malignant or non-malignant)
• • 2. Age 0 - 24.99 years 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 graft-versus-host disease 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. Second or greater allogeneic transplant
• • 2. Weight 7 kg or less
• • 3. Pure CD34+ selected haploidentical stem cell transplant (not including CD34 enrichment used in alpha-beta TCR depleted haploidentical transplants, which is 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).