Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
NCT ID: NCT04372524
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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RECRUITING
350 participants
OBSERVATIONAL
2020-11-15
2025-01-31
Brief Summary
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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.
Detailed Description
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The investigators will be enrolling allogeneic HSCT recipients before conditioning, following these patients prospectively until 12-months (+/- 1 month) post-transplant for the development of all forms of GvHD (classical acute, late acute and chronic GvHD), collecting blood samples at day +60 (+/- 7 days), day +100 (+/- 14 days), and at the onset of either late acute or chronic GvHD. Two extra blood samples will be collected exclusively from HAPLO transplant recipients, who never developed any late-acute GvHD or chronic GVHD at the 6- and 12-month post-transplant time points. In addition, clinical data will be collected at different time points.
Case report forms of standard transplant related data will be completed and entered into a REDCap database.
Blood samples will be drawn and shipped to the Central Laboratory in Vancouver, BC, Canada, processed, analyzed, and the final biomarker risk algorithm completed. Selected clinicians will be offered to complete a short survey asking about their perception of the feasibility of altering their approach to cGvHD management based upon these results.
If chronic GvHD develops at any time after transplant (day 0 to 1 year), or if any form of GvHD occurs at or after day +100 (whether late acute, chronic GvHD, or overlap syndrome), a blood sample will be drawn before escalating immune suppression, and the onset GvHD case report form will be completed following the protocol. If chronic GvHD is confirmed, an additional CRF will be submitted at 24-months (+/- 3 months) post-transplant to document new chronic GvHD manifestations, severity, and response to therapy.
Study participants will have between 2 and 4 blood samples drawn over the course of 1-year post-transplant, depending upon their event and GvHD status.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Allogeneic HSC Transplant recipients
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Age 0 - 24.99 years 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 graft-versus-host disease prophylaxis strategy, including serotherapy such as ATG or alemtuzumab
6. Haploidentical transplants, including post-transplant cyclophosphamide and alpha-beta TCR depletion, are allowed
Exclusion Criteria
2. Weight 7 kg or less
3. Pure CD34+ selected haploidentical stem cell transplant (not including CD34 enrichment used in alpha-beta TCR depleted haploidentical transplants, which is 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).
0 Years
24 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Kirk Schultz
Professor of Pediatrics
Principal Investigators
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Kirk R Schultz, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia / BC Children's Hospital Research Institute
Andrew C Harris, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center / Pediatric Stem Cell Transplantation and Cellular Therapies
Locations
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University of California San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Denver, Colorado, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Washington University School of Medicine
St Louis, Missouri, United States
Roswell Park Comprehensive Care Center
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Kevin Magruder
Role: primary
Kayla Ortiz
Role: primary
Judson Russel
Role: primary
Sheri Kersting, CCRP
Role: primary
Heather Cameron
Role: primary
Chima Elenwune
Role: primary
Juanita Cuffee
Role: primary
Katie Cline
Role: primary
Lori Jewell
Role: primary
Kinjal Mistry
Role: primary
Lillie Flynn
Role: primary
Debra Rich
Role: primary
Alecia Lim
Role: primary
David Godin
Role: primary
Samira Mezziani
Role: primary
References
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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.
Other Identifiers
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H19-02032
Identifier Type: -
Identifier Source: org_study_id