Predictive Biomarkers For Pediatric Chronic Graft-Versus-Host Disease

Chronic Graft vs Host Disease Clinical Trial

— ABLE-cGVHD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02067832
• Other study ID #: H12-02890
• Secondary ID: TCF-118695
• Status: Active, not recruiting
• Start date: November 2013
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 302
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

1. Allogeneic hematopoietic stem cell transplantation for any malignant or non-malignant disease.

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:

1. Autologous HSCT.

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.

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Chronic Graft vs Host Disease
• Graft vs Host Disease

Locations

Country	Name	City	State
Austria	ST.Anna Children's Hospital	Vienna
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Montreal Children's Hospital	Montreal	Quebec
Canada	The Sainte-Justine University Hospital Centre	Montreal	Quebec
Canada	Hospital for Sick Children	Toronto	Ontario
Canada	University of British Columbia - BC Children's Hospital	Vancouver	British Columbia
Canada	University of Manitoba	Winnipeg	Manitoba
United States	C S Mott Children's Hospital The University of Michigan	Ann Arbor	Michigan
United States	Children's of Alabama	Birmingham	Alabama
United States	Ann and Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Blair E. Batson Hospital for Children	Jackson	Mississippi
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Morgan Stanley Children's Hospital	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Oregon Health & Science University	Portland	Oregon
United States	All Children's Hospital	Saint Petersburg	Florida
United States	Utah Primary Children's Medical Center	Salt Lake City	Utah
United States	UCSF Benioff Children's Hospital	San Francisco	California
United States	New York Medical College	Valhalla	New York
United States	Children's National Medical Center	Washington	District of Columbia
United States	Nemours A. I. DuPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Countries where clinical trial is conducted

United States,  Austria,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Just before transplant to 12 months post transplant or until diagnosis of cGVHD if precede the 12 months
Secondary	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	Measure will be assessed following the submission of all samples. During the last year of the study (Oct. 2016 - Sept. 2017)