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

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).

Study Overview

Study Details

Study overview

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).

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

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

Condition
Chronic Graft-versus-Host-Disease
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University St. Louis, Saint Louis, Missouri, United States, 63130-4899

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198-5331

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239-3098

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of British Columbia,

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

Study Record Dates

2025-06-30