Chronic Graft-versus-Host-DiseaseNCT04372524
Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
An observational study of Chronic Graft-versus-Host-Disease and Leukemia, run by University of British Columbia at 16 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 24 years
- Conditions the study is for
- Chronic Graft-versus-Host-Disease, Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation
- How many people
- 350 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 15 Nov 2020to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric and adult (under age of 25 y.o.) patients undergoing allogeneic HSCT (hematopoietic stem cell transplantation) before the start of the conditioning regimen.
Who may be able to join
- Any indication for allogeneic hematopoietic stem cell transplant (malignant or non-malignant)
- Age 0 - 24.99 years at the time of transplant (on day 0)
- Any conditioning regimen (including myeloablative or reduced-toxicity/reduced-intensity)
- Any graft source (bone marrow, peripheral blood, cord blood)
- Any graft-versus-host disease prophylaxis strategy, including serotherapy such as ATG or alemtuzumab
- Haploidentical transplants, including post-transplant cyclophosphamide and alpha-beta TCR depletion, are allowed
Who cannot join
- Second or greater allogeneic transplant
- Weight 7 kg or less
- Pure CD34+ selected haploidentical stem cell transplant (not including CD34 enrichment used in alpha-beta TCR depleted haploidentical transplants, which is allowed)
- 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).
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States11 sites, 11 recruiting
- Not yet recruiting
Emory University School of Medicine
Atlanta, Georgia, 30322
Judson Russel, Judson.Russell@choa.org
Muna Qayed, MD, MsCR
- Recruiting
Roswell Park Comprehensive Care Center
Buffalo, New York, 14263
Heather Cameron, 716-845-1780, Heather.Cameron@RoswellPark.org
Nataliya Prokopenko Buxbaum, MD
- Not yet recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Juanita Cuffee, juanita_cuffee@med.unc.edu
Kimberly A Kasow, DO
- Recruiting
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28203
Katie Cline, Katie.Cline@atriumhealth.org
Michael W Kent, MD
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205-2664
Lori Jewell, Lori.Jewell@nationwidechildrens.org
Rajinder Bajwa, MD
- Recruiting
Children's Hospital Colorado
Denver, Colorado, 80045
Kayla Ortiz, Kayla.Pacheco@childrenscolorado.org
Amy Keating, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6311
Lillie Flynn, lillian.f.flynn@vumc.org
Carrie L Kitko, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10174
Chima Elenwune, ElenwunC@mskcc.org
Andrew C Harris, MD
- Recruiting
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, 97239-3098
Kinjal Mistry, mistryk@ohsu.edu
Eneida R Nemecek, MD, MS, MBA
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Kevin Magruder, 415-476-3834, Kevin.Magruder@ucsf.edu
Alexis Melton, MD
- Not yet recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Sheri Kersting, CCRP, skersting@wustl.edu
Shalini Shenoy, MO, MD
Canada5 sites, 4 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Debra Rich, Debra.Rich@albertahealthservices.ca
Victor Lewis, MD
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
David Godin, david.godin.hsj@ssss.gouv.qc.ca
Henrique Bittencourt, MD, PhD
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Samira Mezziani, Samira.Mezziani@MUHC.MCGILL.CA
David Mitchell, MD
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
Alecia Lim, Alecia.Lim@cw.bc.ca
Kirk R. Schultz, MD
- Active, not recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: Biomarker Verification in Pediatric Chronic Graft-Versus-Host Disease: Applied Biomarkers to Minimize Long Term Effects of Childhood/Adolescent Cancer Treatment (ABLE) / Pediatric Transplantation & Cellular Therapy Consortium (PTCTC)
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.
Read the detailed description
Chronic graft-versus-host disease (cGvHD) occurs when the new donor immune system "attacks" tissues in the recipient following allogeneic hematopoietic stem cell transplantation (HSCT), leading to chronic inflammation, scarring and fibrosis, impaired immunity (including immune deficiency and immune dysregulation), and altered organ system functioning. Almost any organ or system has the potential to be affected by cGvHD, although eight organ systems are classically involved, including the skin, eyes, mouth, lungs, liver, gastrointestinal tract, genitourinary tract, and the musculoskeletal system.
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
- Chronic Graft-versus-Host-Disease, Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Blood Cancer, Non-Malignant Hematologic and Lymphocytic Disorder
- Keywords
- cGvHD, HSCT, L-aGvHD, Biomarkers, Blood, Pediatric, Adolescent, Chronic Graft-versus-Host-Disease, Hematopoietic Stem Cell Transplant, Late acute Graft-versus-Host Disease
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Leukemia, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 100 (+/- 14 days) post-transplant
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the time of diagnosis
Secondary outcomes (2)
Demonstration of identifiable and reproducible differences in diagnostics of cGvHD and L-aGvHD
Metrics to measure this outcome will employ the difference in biomarkers (in combination with clinical manifestation) that can be used to discriminate between cGvHD and L-aGvHD and aid clinicians in establishing a more accurate diagnosis. Laboratory procedure and statistical data analysis will be used to achieve this.
Measured: At the end of the study by year 2025
Determination of patient's risk profile and prediction of treatment responses
Utilizing cGvHD specific biomarkers, clinicians will be able to predict patient's treatment responses and chose the more accurate and effective treatment options.
Measured: At the end of the study by year 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start15 Nov 2020
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Graft-versus-Host-DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirk Schultz, University of British Columbia
- Investigators
- Kirk R Schultz, MD, Principal investigator, University of British Columbia / BC Children's Hospital Research InstituteAndrew C Harris, MD, Principal investigator, Memorial Sloan Kettering Cancer Center / Pediatric Stem Cell Transplantation and Cellular Therapies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372524
- Sponsor's protocol ID
- H19-02032
- Status last verified
- Dec 2023
- First submitted
- 24 Apr 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32047896Cuvelier 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.
PubMed 31043425
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Verification in Pediatric Chronic Graft-Versus-Host Disease: Applied Biomarkers to Minimize Long Term Effects of Childhood/Adolescent Cancer Treatment (ABLE) / Pediatric Transplantation & Cellular Therapy Consortium (PTCTC)
- ClinicalTrials.gov ID
- NCT04372524
- Acronym / sponsor ID
- H19-02032
- Conditions
- Chronic Graft-versus-Host-Disease, Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Blood Cancer, Non-Malignant Hematologic and Lymphocytic Disorder
- Keywords
- cGvHD, HSCT, L-aGvHD, Biomarkers, Blood, Pediatric, Adolescent, Chronic Graft-versus-Host-Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic graft-versus-host disease (cGvHD) occurs when the new donor immune system "attacks" tissues in the recipient following allogeneic hematopoietic stem cell transplantation (HSCT), leading to chronic inflammation, scarring and fibrosis, impaired immunity (including immune deficiency and immune dysregulation), and altered organ system functioning. Almost any organ or system has the potential to be affected by cGvHD, although eight organ systems are classically involved, including the skin, eyes, mouth, lungs, liver, gastrointestinal tract, genitourinary tract, and the musculoskeletal system.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric and adult (under age of 25 y.o.) patients undergoing allogeneic HSCT (hematopoietic stem cell transplantation) before the start of the conditioning regimen.
Key inclusion criteria (6 listed)
- Any indication for allogeneic hematopoietic stem cell transplant (malignant or non-malignant)
- Age 0 - 24.99 years at the time of transplant (on day 0)
- Any conditioning regimen (including myeloablative or reduced-toxicity/reduced-intensity)
- Any graft source (bone marrow, peripheral blood, cord blood)
- Any graft-versus-host disease prophylaxis strategy, including serotherapy such as ATG or alemtuzumab
Key exclusion criteria (4 listed)
- Second or greater allogeneic transplant
- Weight 7 kg or less
- Pure CD34+ selected haploidentical stem cell transplant (not including CD34 enrichment used in alpha-beta TCR depleted haploidentical transplants, which is allowed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Day 60 blood sample collection
Time frame: Day 60 (+/- 7 days) post-transplant
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 100 blood sample collection
Time frame: Day 100 (+/- 14 days) post-transplant
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.
Onset CvHD blood sample collection
Time frame: The day of initial diagnosis
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.
Baseline transplant clinical data collection at Day 0
Time frame: Between day 0 (day of transplant) and day +21
Baseline Transplant Data Case Report Form to be completed. Clinical data will be used in data analysis.
Clinical data collection at Day 60
Time frame: Day 60 (+/- 7 days) post-transplant
Day 60 Case Report Form to be completed. Clinical data will be used in data analysis.
Clinical data collection at Day 100
Time frame: Day 100 (+/- 14 days) post-transplant
Case Report Form to be completed. Clinical data will be used in data analysis.
Clinical data collection at 6 months
Time frame: 6 Months (+/- 1 month) post-transplant
Case Report Form to be completed. Clinical data will be used in data analysis.
Clinical data collection at 12 months
Time frame: 12 Months (+/- 1 month) post-transplant
Case Report Form to be completed. Clinical data will be used in data analysis.
Clinical data collection at 24 months
Time frame: 24 Months (+/- 1 month) post-transplant
Case Report Form to be completed. Clinical data will be used in data analysis.
Clinical data collection at onset of GvHD
Time frame: At the time of diagnosis
Case Report Form to be completed. Clinical data will be used in data analysis.
2 secondary outcomes
Demonstration of identifiable and reproducible differences in diagnostics of cGvHD and L-aGvHD
Time frame: At the end of the study by year 2025
Determination of patient's risk profile and prediction of treatment responses
Time frame: At the end of the study by year 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 32047896Schultz 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.
- Background: PubMed 31043425Cuvelier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk R Schultz, MD principal investigator
University of British Columbia / BC Children's Hospital Research Institute
Andrew C Harris, MD principal investigator
Memorial Sloan Kettering Cancer Center / Pediatric Stem Cell Transplantation and Cellular Therapies
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Graft-versus-Host-Disease and Leukemia, run by University of British Columbia at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Ostroumov, PhD (604-875-2000 ext. 6648, Elena.Ostroumov@bcchr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 60 blood sample collection (time frame: Day 60 (+/- 7 days) post-transplant). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372524, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.