NCT04372524|Unknown
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Sponsor study identifier
observational
350
2 countries
16
Study Start
November 15, 2020
Actual (reported)Primary Completion
January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study will validate a previously developed pediatric prognostic biomarker algorithm aimed at improving prediction of risk for the later development of chronic graft-versus-host disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell transplant. By developing an early risk stratification of patients into low-, intermediate-, and high-risk for future cGvHD development (based upon their biomarker profile, before the onset of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed based upon an individual's biological risk profile. This study will also continue research into diagnostic biomarkers of cGvHD, and begin work into biomarker models that predict clinical response to cGvHD therapies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 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.
April 24, 2020
Actual (reported)May 4, 2020
Actual (reported)November 15, 2020
Actual (reported)January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Day 60 blood sample collection
Validation of prognostic and diagnostic power of cGvHD biomarkers and testing of the biomarker assay performance of Day 60 post-transplant blood sample. Using this algorithm-based assay the investigators will attempt to develop risk assignment for cGvHD and L-aGvHD at Day 60 and determine whether this time point has a similar (or improved) predictive value to the day +100 (+/-14 days). Flow Cytometry and ELISA assays will be used for biomarker measurement.
Day 60 (+/- 7 days) post-transplant
Day 100 blood sample collection
Validation of prognostic and diagnostic power of cGvHD biomarkers and testing of the biomarker assay performance of Day 100 post-transplant blood sample (diagnostic biomarkers). Using this algorithm-based assay the investigators will attempt to develop risk assignment for cGvHD and L-aGvHD at Day 100. Flow Cytometry and ELISA assays will be used for biomarker measurement.
Day 100 (+/- 14 days) post-transplant
Five possible patient scenarios are anticipated to occur in those who underwent allogeneic HSCT: * Early event (e.g. death, non-engraftment) occurring before day 100. * No late-acute or chronic GvHD ever develops at any time point in the first year post-transplant (regardless of whether or not classical acute GvHD develops in the first 100 days after transplant). * Early-onset chronic GvHD (including overlap syndrome) occurred before day 60. * Early-onset chronic GvHD (including overlap syndrome) occurred between day 60 and day 100. * Chronic GvHD after Day 100, Late-acute GvHD (de-novo or recurrent) after day 100, or cases of overlap syndrome occurred after day 100.
Pediatric and adult (under age of 25 y.o.) patients undergoing allogeneic HSCT (hematopoietic stem cell transplantation) before the start of the conditioning regimen.
University of California San Francisco
San Francisco, California, 94158, United States
Children's Hospital Colorado
Denver, Colorado, 80045, United States
Schultz KR, Kariminia A, Ng B, Abdossamadi S, Lauener M, Nemecek ER, Wahlstrom JT, Kitko CL, Lewis VA, Schechter T, Jacobsohn DA, Harris AC, Pulsipher MA, Bittencourt H, Choi SW, Caywood EH, Kasow KA, Bhatia M, Oshrine BR, Flower A, Chaudhury S, Coulter D, Chewning JH, Joyce M, Savasan S, Pawlowska AB, Megason GC, Mitchell D, Cheerva AC, Lawitschka A, Azadpour S, Ostroumov E, Subrt P, Halevy A, Mostafavi S, Cuvelier GDE. Immune profile differences between chronic GVHD and late acute GVHD: results of the ABLE/PBMTC 1202 studies. Blood. 2020 Apr 9;135(15):1287-1298. doi: 10.1182/blood.2019003186.
Cuvelier GDE, Nemecek ER, Wahlstrom JT, Kitko CL, Lewis VA, Schechter T, Jacobsohn DA, Harris AC, Pulsipher MA, Bittencourt H, Choi SW, Caywood EH, Kasow KA, Bhatia M, Oshrine BR, Flower A, Chaudhury S, Coulter D, Chewning JH, Joyce M, Savasan S, Pawlowska AB, Megason GC, Mitchell D, Cheerva AC, Lawitschka A, West LJ, Pan B, Al Hamarneh YN, Halevy A, Schultz KR. Benefits and challenges with diagnosing chronic and late acute GVHD in children using the NIH consensus criteria. Blood. 2019 Jul 18;134(3):304-316. doi: 10.1182/blood.2019000216. Epub 2019 May 1.
Kirk R Schultz, MD
University of British Columbia / BC Children's Hospital Research Institute
Andrew C Harris, MD
Memorial Sloan Kettering Cancer Center / Pediatric Stem Cell Transplantation and Cellular Therapies
First Submitted
April 24, 2020
First Posted
May 4, 2020
Study Start
November 15, 2020
Actual (reported)Primary Completion
January 2024
Estimated (date passed)Leflunomide in Treating Patients With Steroid Dependent Chronic Graft Versus Host Disease
Onset CvHD blood sample collection
Validation of prognostic and diagnostic power of cGvHD biomarkers and testing of the biomarker assay performance of the GvHD onset blood sample. The investigators will attempt to determine whether biomarkers present at the onset of new late-acte GvHD developing after day +100 (diagnostic biomarkers) or are similar to or different than at the onset of chronic GvHD. Flow Cytometry and ELISA assays will be used for biomarker measurement.
The day of initial diagnosis
Baseline transplant clinical data collection at Day 0
Baseline Transplant Data Case Report Form to be completed. Clinical data will be used in data analysis.
Between day 0 (day of transplant) and day +21
Clinical data collection at Day 60
Day 60 Case Report Form to be completed. Clinical data will be used in data analysis.
Day 60 (+/- 7 days) post-transplant
Clinical data collection at Day 100
Case Report Form to be completed. Clinical data will be used in data analysis.
Day 100 (+/- 14 days) post-transplant
Clinical data collection at 6 months
Case Report Form to be completed. Clinical data will be used in data analysis.
6 Months (+/- 1 month) post-transplant
Clinical data collection at 12 months
Case Report Form to be completed. Clinical data will be used in data analysis.
12 Months (+/- 1 month) post-transplant
Clinical data collection at 24 months
Case Report Form to be completed. Clinical data will be used in data analysis.
24 Months (+/- 1 month) post-transplant
Clinical data collection at onset of GvHD
Case Report Form to be completed. Clinical data will be used in data analysis.
At the time of diagnosis
Demonstration of identifiable and reproducible differences in diagnostics of cGvHD and L-aGvHD
At the end of the study by year 2025
Determination of patient's risk profile and prediction of treatment responses
At the end of the study by year 2025
6 Month HAPLO blood sample collection
6 Months (+/- 1 month) post-transplant
12 Month HAPLO blood sample collection
12 Months (+/- 1 month) post-transplant
Contact the study team to confirm eligibility.
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Roswell Park Comprehensive Care Center
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10174, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205-2664, United States
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, 97239-3098, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6311, United States
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 5, 2023
Record last verified: 2023-12
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