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"

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.

Study Overview

• Status: Completed
• Conditions: Allografts; Oral cGVHD
• Intervention / Treatment: Other: Evaluation of oral cGVHD

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06000
      • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who received an allograft between octobre 2023 and May 2025 at CHU de Nice.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with oral cGVHD	Other: Evaluation of oral cGVHD; analysis statistics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	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.	3 months, 6 months, 1 years and 1,5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival,	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.	3 months, 6 months, 1 years and 1,5 years
Non relapse mortality	Non-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.	3 months, 6 months, 1 years and 1,5 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 25Hemato01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No