RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-07-01
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05692713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Any indication for allogeneic hematopoietic stem cell transplant (malignant and nonmalignant);
  2. 2. Age \>18 years (those who reached the age of majority) at the time of transplant (on Day 0);
  3. 3. Any conditioning regimen (including myeloablative or reduced-toxicity/reduced-intensity);
  4. 4. Any graft source (bone marrow, peripheral blood, cord blood);
  5. 5. Any GvHD prophylaxis strategy, including serotherapy such as ATG or alemtuzumab;
  6. 6. Haploidentical transplants, including post-transplant cyclophosphamide and alpha-beta TCR depletion, are allowed
  1. 1. Age \< 18 years (or under the age of majority) at the time of consent;
  2. 2. Second or greater allogeneic transplant;
  3. 3. Pure CD34+ selected stem cell grafts (not including C34+ cell enrichment used in alpha-beta TCR depleted haploidentical grafts, which are allowed);
  4. 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).

Contacts and Locations

Study Contact

Elena Ostroumov, PhD
CONTACT
604-875-2000
elena.ostroumov@bcchr.ca

Principal Investigator

Kirk R. Schultz, MD
PRINCIPAL_INVESTIGATOR
University of British Columbia / BC Children's Hospital

Study Locations (Sites)

Washington University St. Louis
Saint Louis, Missouri, 63130-4899
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5331
United States
Oregon Health & Science University
Portland, Oregon, 97239-3098
United States

Collaborators and Investigators

Sponsor: University of British Columbia

  • Kirk R. Schultz, MD, PRINCIPAL_INVESTIGATOR, University of British Columbia / BC Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-01
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-07-01
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • cGvHD
  • Biomarkers
  • Blood
  • Immune cells
  • Prognostic / diagnostic algorithm
  • Adult HSC transplant recipients
  • Blood cancers
  • Allogeneic HSCT

Additional Relevant MeSH Terms

  • Chronic Graft-versus-Host-Disease
  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Leukemia
  • Blood Cancer
  • Non-Malignant Hematologic and Lymphocytic Disorder