Clinical trial · Observational
The Oral cGVHD as a Predictive Factor of Graft Versus Leukaemia Effect in Patients Who Received an Allograft
"Oral Chronic Graft-Versus-Host Disease (cGVHD) as a Potential Clinical Marker of the Graft-Versus-Leukemia (GVL) Effect in Allogeneic Hematopoietic Stem Cell Transplantation:Prospective Single-Center Study"
- 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)
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the standard treatment for many malignant blood disorders. Its effectiveness is based on the graft-versus-leukemia (GVL) effect, which is intrinsically linked to the occurrence of graft-versus-host disease (GVHD). While GVHD reflects favorable alloreactivity, its severe forms increase While GVHD reflects favorable allograft reactivity, its severe forms increase non-relapse mortality (NRM) and impair quality of life. Currently, there is no simple clinical marker that can predict or monitor the efficacy of the GVL effect. The investigators therefore hypothesized that chronic oral GVHD, a common and easily identifiable manifestation, could reflect beneficial alloreactivity, reflecting a balance between GVL effect and toxicity. The investigators conducted a prospective, observational, single-center study including patients transplanted at the Nice University Hospital between October 2023 and May 2025, followed by a standardized stomatological protocol before and after transplantation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allografts | — | UNRESOLVED | — |
| Oral cGVHD | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evaluation of oral cGVHD | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient with oral cGVHD
- interventionNames
- Other: Evaluation of oral cGVHD
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 3 months, 6 months, 1 years and 1,5 years
- description
- Overall Survival (OS) is defined as the time, measured in months, from the date of study entry (or randomization, depending on protocol specifications) to death from any cause. Participants who are alive at the time of the last known follow-up are censored at that date.
Secondary outcomes (2)
- measure
- Disease free survival,
- timeFrame
- 3 months, 6 months, 1 years and 1,5 years
- description
- Disease-Free Survival (DFS) is defined as the time, measured in months, from the date of curative-intent treatment (or randomization, according to protocol specifications) to the first documented recurrence of the disease or death from any cause, whichever occurs first. Participants who remain alive and free of disease at the time of the last known follow-up are censored at that date.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who received an allograft between octobre 2023 and May 2025 at CHU de Nice. Exclusion Criteria: * Patients who did not received an allograft
References
Publications (0)
Data not yet available