Chronic Graft vs Host DiseaseABLE-cGVHDNCT02067832
Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease
An observational study of Chronic Graft vs Host Disease, run by University of British Columbia at 25 sites in 3 countries.
Trial summary
Chronic graft-versus-host disease (cGVHD) can be hard to diagnose, difficult to manage and contributes significantly to morbidity and mortality in hematopoietic stem cell transplantation patients. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Graft vs Host Disease
- How many people
- 302 participants
- Where
- 25 sitesin 3 countries
- Study dates
- Nov 2013to Dec 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Recipients and donors of allogeneic hematopoietic stem cell transplantation
Who may be able to join
- Allogeneic hematopoietic stem cell transplantation for any malignant or non-malignant disease.
- Age 0-17.99 years at the time of transplantation.
- Bone marrow, peripheral blood stem cell and umbilical cord blood (including single or double cord blood) as the graft source.
- Any conditioning regimen with any chemotherapy / radiation therapy combination. Haploidentical donor transplants with post-transplant cyclophosphamide are also allowed.
- Use of serotherapy is permitted.
- Any graft-versus-host disease prophylaxis is permitted, including post-HSCT cyclophosphamide.
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- If participant weighs between 0-20 kg, participant must be able to provide 15 ml of whole blood at each time point.
- 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.
- Written informed consent from parents.
- Assent from study participant when appropriate.
- Participation on other clinical trials is acceptable.
Who cannot join
- Autologous HSCT.
- 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.
- Ex-vivo T-cell depletion of graft source (e.g. CD34 selection).
- Second (or greater) allogeneic transplants (first allogeneic transplant where a previous autologous transplant was performed is permitted).
- Syngeneic transplants.
Trial locations and contacts
25 sites in 3 countries.
25 sites in 3 countries
United States18 sites
C S Mott Children's Hospital The University of Michigan
Ann Arbor, Michigan, 48109-1274
Children's of Alabama
Birmingham, Alabama, 35233
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2605
Children's Hospital of Michigan
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010
Blair E. Batson Hospital for Children
Jackson, Mississippi, 39216
Nemours Children's Clinic
Jacksonville, Florida, 32207
Loma Linda University Medical Center
Loma Linda, California, 92354
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee
Morgan Stanley Children's Hospital
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7140
Oregon Health & Science University
Portland, Oregon, 97239
Utah Primary Children's Medical Center
Salt Lake City, Utah, 84132
UCSF Benioff Children's Hospital
San Francisco, California, 94143
All Children's Hospital
St. Petersburg, Florida, 33701
New York Medical College
Valhalla, New York, 10595
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Nemours A. I. DuPont Hospital for Children
Wilmington, Delaware, 19803
Canada6 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
The Sainte-Justine University Hospital Centre
Montreal, Quebec, H3T 1C5
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
University of British Columbia - BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
University of Manitoba
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Applying Biomarkers to Long-term Effects in Child and Adolescent Cancer Treatment (ABLE Team) - Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease
Chronic graft-versus-host disease (cGVHD) can be hard to diagnose, difficult to manage and contributes significantly to morbidity and mortality in hematopoietic stem cell transplantation patients.
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.
Read more
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.
- Conditions
- Chronic Graft vs Host Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of predictive bio-markers for pediatric chronic Graft-Versus-Host Disease (cGVHD) in Hematopoietic Stem Cell Transplant (HSCT) recipients
The study will try to determine the prevalence (or levels) of high-probability predictive plasma and cellular cGVHD bio-markers in pediatric patients undergoing allogeneic HSCT from blood samples
Measured: Just before transplant to 12 months post transplant or until diagnosis of cGVHD if precede the 12 months
Secondary outcomes (1)
Validation of "predictive" cGVHD bio-markers
To determine and validate whether "predictive" cGVHD bio-markers present before the onset of cGVHD are able to predict a subset of pediatric patients at greatest risk for the development of cGVHD in the future
Measured: Measure will be assessed following the submission of all samples. During the last year of the study (Oct. 2016 - Sept. 2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2024 (estimated)
- Study completionDec 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 vs 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
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
- Geoff Cuvelier, MD, Principal investigator, University of ManitobaKirk R Schultz, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067832
- Sponsor's protocol ID
- H12-02890
- Other IDs
- TCF-118695
- Acronym
- ABLE-cGVHD
- Status last verified
- Dec 2023
- First submitted
- 20 Jan 2014
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36219586Subburaj 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.
PubMed 34534280
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
- Applying Biomarkers to Long-term Effects in Child and Adolescent Cancer Treatment (ABLE Team) - Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease
- ClinicalTrials.gov ID
- NCT02067832
- Acronym / sponsor ID
- ABLE-cGVHD / H12-02890
- Conditions
- Chronic Graft vs Host Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Feb 2014 (estimated)
- 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.
Chronic graft-versus-host disease (cGVHD) can be hard to diagnose, difficult to manage and contributes significantly to morbidity and mortality in hematopoietic stem cell transplantation patients.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Recipients and donors of allogeneic hematopoietic stem cell transplantation
Key inclusion criteria (11 listed)
- Allogeneic hematopoietic stem cell transplantation for any malignant or non-malignant disease.
- Age 0-17.99 years at the time of transplantation.
- Bone marrow, peripheral blood stem cell and umbilical cord blood (including single or double cord blood) as the graft source.
- Any conditioning regimen with any chemotherapy / radiation therapy combination. Haploidentical donor transplants with post-transplant cyclophosphamide are also allowed.
- Use of serotherapy is permitted.
Key exclusion criteria (5 listed)
- Autologous HSCT.
- 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.
- Ex-vivo T-cell depletion of graft source (e.g. CD34 selection).
- Second (or greater) allogeneic transplants (first allogeneic transplant where a previous autologous transplant was performed is permitted).
- Syngeneic transplants.
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
Identification of predictive bio-markers for pediatric chronic Graft-Versus-Host Disease (cGVHD) in Hematopoietic Stem Cell Transplant (HSCT) recipients
Time frame: Just before transplant to 12 months post transplant or until diagnosis of cGVHD if precede the 12 months
The study will try to determine the prevalence (or levels) of high-probability predictive plasma and cellular cGVHD bio-markers in pediatric patients undergoing allogeneic HSCT from blood samples
1 secondary outcome
Validation of "predictive" cGVHD bio-markers
Time frame: Measure will be assessed following the submission of all samples. During the last year of the study (Oct. 2016 - Sept. 2017)
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.
- Derived from this study: PubMed 36219586Cuvelier 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.
- Derived from this study: PubMed 34534280Subburaj 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.
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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.
Geoff Cuvelier, MD principal investigator
University of Manitoba
Kirk R Schultz, MD principal investigator
University of British Columbia
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Graft vs Host Disease, run by University of British Columbia at 25 sites in 3 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 11 inclusion and 5 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 25 sites in United States, Canada, Austria. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of predictive bio-markers for pediatric chronic Graft-Versus-Host Disease (cGVHD) in Hematopoietic Stem Cell Transplant (HSCT) recipients (time frame: Just before transplant to 12 months post transplant or until diagnosis of cGVHD if precede the 12 months). 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 NCT02067832, 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.