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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07271498
Enrollment
93
Registered
2025-12-09
Start date
2023-10-01
Completion date
2025-10-01
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allografts, Oral cGVHD

Brief summary

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.

Interventions

OTHEREvaluation of oral cGVHD

analysis statistics

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival3 months, 6 months, 1 years and 1,5 yearsOverall 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

MeasureTime frameDescription
Disease free survival,3 months, 6 months, 1 years and 1,5 yearsDisease-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.
Non relapse mortality3 months, 6 months, 1 years and 1,5 yearsNon-Relapse Mortality (NRM) is defined as the time, measured in months, from the date of allogeneic transplantation (or study entry, depending on protocol specifications) to death without prior disease relapse or progression. Deaths occurring after documented relapse/progression are not counted as NRM events. Participants who are alive without relapse at last follow-up are censored at that date.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026