Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT05692713

Conditions

Chronic Graft-versus-Host-Disease

Allogeneic Hematopoietic Stem Cell Transplantation

Leukemia

Blood Cancer

Non-Malignant Hematologic and Lymphocytic Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05692713

Start date

Jul 1, 2023

Status verified date

Dec, 2023

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

INCLUSION CRITERIA:

1. Any indication for allogeneic hematopoietic stem cell transplant (malignant and nonmalignant);
2. Age >18 years (those who reached the age of majority) 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 GvHD 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. Age < 18 years (or under the age of majority) at the time of consent;
2. Second or greater allogeneic transplant;
3. Pure CD34+ selected stem cell grafts (not including C34+ cell enrichment used in alpha-beta TCR depleted haploidentical grafts, which are 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

320 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Onset of Early cGvHD [ Time Frame: Before Day 100 post-transplant ]
  • Onset of cGvHD or L-aGvHD [ Time Frame: After Day 100 post-transplant ]
  • No cGvHD or L-aGvHD [ Time Frame: 12 months post-transplant ]

Central Contacts and Locations

Central contacts

Elena Ostroumov, PhD

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

Locations

Washington University St. Louis

Recruiting

Saint Louis, Missouri, United States, 63130-4899

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198-5331

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239-3098

UHN Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C4

More Information

Sponsor

University of British Columbia

Last update posted

Dec 8, 2023

Last verified

Dec, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-12-08.