Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease
NCT ID: NCT02067832
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
302 participants
OBSERVATIONAL
2013-11-30
2025-12-31
Brief Summary
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The research will look into identifying and validating cGVHD biological indicators (=bio-markers) which will be evaluated whether they can predict a future development of the disease.
The study hypothesis is that a number of previously reported cGVHD bio-markers, known to be present at the time of cGVHD diagnosis, will also be present at earlier time points, before cGVHD develops.
Following validation, the bio-markers will be beneficial for finding those patients who are in higher risk to develop cGVHD.
By identifying the higher-risk group, which is more likely to develop cGVHD, a pre-emptive therapy might be applied in order to prevent or reduce the prevalence of the disease.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Age 0-17.99 years at the time of transplantation.
3. Bone marrow, peripheral blood stem cell and umbilical cord blood (including single or double cord blood) as the graft source.
4. Any conditioning regimen with any chemotherapy / radiation therapy combination. Haploidentical donor transplants with post-transplant cyclophosphamide are also allowed.
5. Use of serotherapy is permitted.
6. Any graft-versus-host disease prophylaxis is permitted, including post-HSCT cyclophosphamide.
7. If participant weighs between 0-20 kg, participant must be able to provide 15 ml of whole blood at each time point.
8. If participant weighs over 20 kg, participant must be able to provide 1ml/kg of whole blood, up to a maximum of 23 mL for the pre-conditioning sample and 32 mL for samples at day +100, 6-months, 12-months, +/- the cGVHD sample.
9. Written informed consent from parents.
10. Assent from study participant when appropriate.
11. Participation on other clinical trials is acceptable.
Exclusion Criteria
2. Patients referred to a Bone Marrow Transplant (BMT) center from a non-BMT center, where it is anticipated (at the discretion of the center PI) that adequate follow up according to the rules of this protocol can not be met, including the requirement for a reassessment by the BMT center at the time of cGVHD diagnosis.
3. Ex-vivo T-cell depletion of graft source (e.g. CD34 selection).
4. Second (or greater) allogeneic transplants (first allogeneic transplant where a previous autologous transplant was performed is permitted).
5. Syngeneic transplants.
18 Years
ALL
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Kirk Schultz
Principle Investigator
Principal Investigators
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Geoff Cuvelier, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Kirk R Schultz, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Children's of Alabama
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
Nemours A. I. DuPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
C S Mott Children's Hospital The University of Michigan
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Blair E. Batson Hospital for Children
Jackson, Mississippi, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Morgan Stanley Children's Hospital
New York, New York, United States
New York Medical College
Valhalla, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Utah Primary Children's Medical Center
Salt Lake City, Utah, United States
ST.Anna Children's Hospital
Vienna, , Austria
Alberta Children's Hospital
Calgary, Alberta, Canada
University of British Columbia - BC Children's Hospital
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
The Sainte-Justine University Hospital Centre
Montreal, Quebec, Canada
Countries
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References
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Cuvelier GDE, Ng B, Abdossamadi S, Nemecek ER, Melton A, Kitko CL, Lewis VA, Schechter T, Jacobsohn DA, Harris AC, Pulsipher MA, Bittencourt H, Choi SW, Caywood EH, Kasow KA, Bhatia M, Oshrine BR, Chaudhury S, Coulter D, Chewning JH, Joyce M, Savasan S, Pawlowska AB, Megason GC, Mitchell D, Cheerva AC, Lawitschka A, Ostroumov E, Schultz KR. A diagnostic classifier for pediatric chronic graft-versus-host disease: results of the ABLE/PBMTC 1202 study. Blood Adv. 2023 Jul 25;7(14):3612-3623. doi: 10.1182/bloodadvances.2022007715.
Subburaj D, Ng B, Kariminia A, Abdossamadi S, Lauener M, Nemecek ER, Rozmus J, Kharbanda S, Kitko CL, Lewis VA, Schechter-Finklestein T, Jacobsohn DA, Harris AC, Pulsipher MA, Bittencourt H, Choi SW, Caywood EH, Kasow KA, Bhatia M, Oshrine BR, Coulter D, Chewning JH, Joyce M, Pawlowska AB, Megason GC, Lawitschka A, Ostroumov E, Klein Geltink R, Cuvelier GDE, Schultz KR. Metabolomic identification of alpha-ketoglutaric acid elevation in pediatric chronic graft-versus-host disease. Blood. 2022 Jan 13;139(2):287-299. doi: 10.1182/blood.2021013244.
Other Identifiers
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TCF-118695
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H12-02890
Identifier Type: -
Identifier Source: org_study_id