Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease (ABLE3.0/CTTC2201)

NCT05692713 | Unknown

• 1 other identifier: H22-03310
• Study Type: observational
• Target: 320
• Locations: 2 countries
• Sites: 10

Brief Summary

Chronic graft-versus-host disease (cGvHD) is one of the most serious complications following BMT (Bone Marrow Transplantation). cGvHD occurs when donor immune cells "attack" the tissues and organs of the person receiving the BMT. cGvHD can be difficult to treat once it is established leading to poor quality of life for recipients of a BMT. The goal of this study is to determine if, by using biomarkers, the investigators can predict which patients are at the highest risk of developing cGvHD after BMT, before cGvHD develops. The ABLE3.0 / CTTC 2201 study will validate and potentially refine the initial predictive biomarker algorithm developed from the original ABLE/PBTMC 1202 study (ABLE1.0), allowing clinicians the ability to pre-emptively predict their patient's future risk of developing both late-acute and chronic GvHD. This will provide the foundation for the later development of clinical trials aimed at reducing immune suppression quicker after transplant for low-risk patients (\<10% risk) and justifying more intensive approaches such as pre-emptive treatments before the onset of chronic GvHD in high-risk patients (\>45% risk).

Conditions

Chronic Graft-versus-Host-Disease; Allogeneic Hematopoietic Stem Cell Transplantation; Leukemia; Blood Cancer; Non-Malignant Hematologic and Lymphocytic Disorder

Keywords

cGvHD; Biomarkers; Blood; Immune cells; Prognostic / diagnostic algorithm; Adult HSC transplant recipients; Blood cancers; Allogeneic HSCT

Outcome Measures

Primary Outcomes (3)

• Onset of Early cGvHD

  Early chronic GvHD including overlap syndrome

  Before Day 100 post-transplant

• Onset of cGvHD or L-aGvHD

  Chronic GvHD after Day 100, Late acute GvHD (de-novo or recurrent) after Day 100, or cases of overlap syndrome after Day 100

  After Day 100 post-transplant

• No cGvHD or L-aGvHD

  No Chronic or Late-acute GvHD ever develops at any time point in first year post-transplant (regardless of whether or not classical acute GvHD develops in the first 100 days after transplant)

  12 months post-transplant

Secondary Outcomes (1)

• Early Event (criterium for coming off-study)

  Before Day 100 post-transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Allogeneic Stem Cell Transplant recipients

You may qualify if:

• Any indication for allogeneic hematopoietic stem cell transplant (malignant and nonmalignant);
• Age \>18 years (those who reached the age of majority) 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 GvHD prophylaxis strategy, including serotherapy such as ATG or alemtuzumab;
• Haploidentical transplants, including post-transplant cyclophosphamide and alpha-beta TCR depletion, are allowed

You may not qualify if:

• Age \< 18 years (or under the age of majority) at the time of consent;
• Second or greater allogeneic transplant;
• Pure CD34+ selected stem cell grafts (not including C34+ cell enrichment used in alpha-beta TCR depleted haploidentical grafts, which are 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).

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (10)

Washington University St. Louis

St Louis, Missouri, 63130-4899, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198-5331, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

NOT YET RECRUITING

NS Health

Halifax, Nova Scotia, B3H 2Y9, Canada

NOT YET RECRUITING

Juravinski Hospital & Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

NOT YET RECRUITING

LHSC: Victoria Hospital

London, Ontario, N6C 2R5, Canada

NOT YET RECRUITING

UHN Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

CHU de Québec - Université Laval

Laval, Quebec, G1R 2J6, Canada

NOT YET RECRUITING

McGill University Health Center

Montreal, Quebec, H3H 2R9, Canada

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, serum, plasma, cells

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Leukemia; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site

Study Officials

• Kirk R. Schultz, MD

  University of British Columbia / BC Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Ostroumov, PhD

CONTACT

604-875-2000; elena.ostroumov@bcchr.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: July 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 30, 2025
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

US (3); CA (7)