NCT05692713|Unknown
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Sponsor study identifier
observational
320
2 countries
10
Study Start
July 1, 2023
Actual (reported)Primary Completion
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 11, 2023
Actual (reported)January 20, 2023
Actual (reported)July 1, 2023
Actual (reported)June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Onset of Early cGvHD
Early chronic GvHD including overlap syndrome
Before Day 100 post-transplant
Onset of cGvHD or L-aGvHD
Chronic GvHD after Day 100, Late acute GvHD (de-novo or recurrent) after Day 100, or cases of overlap syndrome after Day 100
After Day 100 post-transplant
No cGvHD or L-aGvHD
No Chronic or Late-acute GvHD ever develops at any time point in first year post-transplant (regardless of whether or not classical acute GvHD develops in the first 100 days after transplant)
12 months post-transplant
Allogeneic Stem Cell Transplant recipients
Washington University St. Louis
St 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
Blood, serum, plasma, cells
Kirk R. Schultz, MD
University of British Columbia / BC Children's Hospital
First Submitted
January 11, 2023
First Posted
January 20, 2023
Study Start
July 1, 2023
Actual (reported)Primary Completion
June 2025
Estimated (date passed)Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)
Early Event (criterium for coming off-study)
Before Day 100 post-transplant
Contact the study team to confirm eligibility.
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
NS Health
Halifax, Nova Scotia, B3H 2Y9, Canada
Juravinski Hospital & Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
LHSC: Victoria Hospital
London, Ontario, N6C 2R5, Canada
UHN Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C4, Canada
CHU de Québec - Université Laval
Laval, Quebec, G1R 2J6, Canada
McGill University Health Center
Montreal, Quebec, H3H 2R9, Canada
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 8, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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