Clinical trial · Observational
Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease (ABLE3.0/CTTC2201)
Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease. Applied Biomarkers in Late Effects (ABLE) (ABLE3.0/CTTC2201)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Blood Cancer | Liquid Tumor | ALIAS | 0.90 |
| Chronic Graft-versus-Host-Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Non-Malignant Hematologic and Lymphocytic Disorder | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Onset of Early cGvHD
- timeFrame
- Before Day 100 post-transplant
- description
- Early chronic GvHD including overlap syndrome
- measure
- Onset of cGvHD or L-aGvHD
- timeFrame
- After Day 100 post-transplant
- description
- Chronic GvHD after Day 100, Late acute GvHD (de-novo or recurrent) after Day 100, or cases of overlap syndrome after Day 100
- measure
- No cGvHD or L-aGvHD
- timeFrame
- 12 months post-transplant
- description
- 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)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available