Recruiting

Biomarker VerificationBiomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study

Sponsor:

University of British Columbia

Code:

NCT04372524

Conditions

Chronic Graft-versus-Host-Disease

Leukemia

Allogeneic Hematopoietic Stem Cell Transplantation

Blood Cancer

Non-Malignant Hematologic and Lymphocytic Disorder

Eligibility Criteria

Sex: All

Age: 0 - 24

Healthy Volunteers: Not accepted

Study Details

Brief 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.

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.

Conditions

Chronic Graft-versus-Host-Disease

Leukemia

Allogeneic Hematopoietic Stem Cell Transplantation

Blood Cancer

Non-Malignant Hematologic and Lymphocytic Disorder

Study ID

NCT04372524

Start date

Nov 15, 2020

Status verified date

Dec, 2023

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 24

Healthy Volunteers: Not accepted

INCLUSION CRITERIA:

1. Any indication for allogeneic hematopoietic stem cell transplant (malignant or non-malignant)
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:

1. Second or greater allogeneic transplant
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).

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

Day 60 blood sample collection [ Time Frame: Day 60 (+/- 7 days) post-transplant ]
Day 100 blood sample collection [ Time Frame: Day 100 (+/- 14 days) post-transplant ]
Onset CvHD blood sample collection [ Time Frame: The day of initial diagnosis ]
Baseline transplant clinical data collection at Day 0 [ Time Frame: Between day 0 (day of transplant) and day +21 ]
Clinical data collection at Day 60 [ Time Frame: Day 60 (+/- 7 days) post-transplant ]
Clinical data collection at Day 100 [ Time Frame: Day 100 (+/- 14 days) post-transplant ]
Clinical data collection at 6 months [ Time Frame: 6 Months (+/- 1 month) post-transplant ]
Clinical data collection at 12 months [ Time Frame: 12 Months (+/- 1 month) post-transplant ]
Clinical data collection at 24 months [ Time Frame: 24 Months (+/- 1 month) post-transplant ]
Clinical data collection at onset of GvHD [ Time Frame: At the time of diagnosis ]

Central Contacts and Locations

Central contacts

Elena Ostroumov, PhD

604-875-2000 Elena.Ostroumov@bcchr.ca

Sayeh Abdossamadi, PhD

604-875-2454 sabdossamadi@bcchr.ca

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Kevin Magruder

415-476-3834 Kevin.Magruder@ucsf.edu

Principal Investigator:

Alexis Melton, MD

Children's Hospital Colorado

Recruiting

Denver, Colorado, United States, 80045

Contacts

Kayla Ortiz

Kayla.Pacheco@childrenscolorado.org

Principal Investigator:

Amy Keating, MD

Roswell Park Comprehensive Care Center

Recruiting

Buffalo, New York, United States, 14263

Contacts

Heather Cameron

716-845-1780 Heather.Cameron@RoswellPark.org

Principal Investigator:

Nataliya Prokopenko Buxbaum, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10174

Contacts

Chima Elenwune

ElenwunC@mskcc.org

Principal Investigator:

Andrew C Harris, MD

Atrium Health Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Katie Cline

Katie.Cline@atriumhealth.org

Principal Investigator:

Michael W Kent, MD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205-2664

Contacts

Lori Jewell

Lori.Jewell@nationwidechildrens.org

Principal Investigator:

Rajinder Bajwa, MD

Oregon Health & Science University Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239-3098

Contacts

Kinjal Mistry

mistryk@ohsu.edu

Principal Investigator:

Eneida R Nemecek, MD, MS, MBA

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232-6311

Contacts

Lillie Flynn

lillian.f.flynn@vumc.org

Principal Investigator:

Carrie L Kitko, MD

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Debra Rich

Debra.Rich@albertahealthservices.ca

Principal Investigator:

Victor Lewis, MD

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Alecia Lim

Alecia.Lim@cw.bc.ca

Principal Investigator:

Kirk R. Schultz, MD

CHU Sainte-Justine

Recruiting

Montréal, Quebec, Canada, H3T 1C5

Contacts

David Godin

david.godin.hsj@ssss.gouv.qc.ca

Principal Investigator:

Henrique Bittencourt, MD, PhD

McGill University Health Centre

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contacts

Samira Mezziani

Samira.Mezziani@MUHC.MCGILL.CA

Principal Investigator:

David Mitchell, MD

More Information

Sponsor

University of British Columbia

Last update posted

Dec 5, 2023

Last verified

Dec, 2023

Keywords

cGvHD
HSCT
L-aGvHD
Biomarkers
Blood
Pediatric
Adolescent
Chronic Graft-versus-Host-Disease
Hematopoietic Stem Cell Transplant
Late acute Graft-versus-Host Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-12-05.