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

NCT05692713 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2023-12-08

No results posted yet for this study

Summary

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).

Conditions

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

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05692713 on ClinicalTrials.gov