Biomarker Verification in Pediatric Chronic Graft-Versus-Host Disease: Applied Biomarkers to Minimize Long Term Effects of Childhood/Adolescent Cancer Treatment (ABLE)

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Description

The Applied Biomarkers of Late Effects of Childhood Cancer (ABLE) study, in collaboration with the Pediatric Transplantation & Cellular Therapy Consortium (PTCTC), have recently focused on biological correlates (such as T- and B-cells and their respective subsets, NK cells and their subsets, regulatory cell populations, and plasma proteins including cytokines and chemokines) that can be easily measured (using a blood sample) before the onset of cGvHD as a way to predict which patients are at a higher- or lower-risk for the future development of cGvHD.. In doing so, our goal is to develop a clinically applicable biomarker algorithm, whereby patients with a lower risk for developing cGvHD (<10% risk) might have their prophylactic immune suppression withdrawn earlier (and hence avoid additional toxicity and cost, while enhancing immune reconstitution after transplant), while those at higher risk for later developing cGvHD (approximately 45% risk or higher) could potentially be enrolled on early phase clinical trials testing pre-emptive immune suppressive therapies, aimed at reducing the future risk of developing this severe complication.

Details
Age

Child to Adult

Eligibility

Patients under 25 years of age with any indication for allogeneic hematopoietic stem cell transplantInclusion Criteria 1. Any indication for allogeneic hematopoietic stem cell transplant (malignant and nonmalignant) 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).

Locations

Childrens Hospital Colorado

Principal Investigator
Photograph of Laura McLaughlin

Laura McLaughlin

Study ID

Protocol Number: 21-3395

More information available at ClinicalTrials.gov: NCT04372524

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