The Oral cGVHD as a Predictive Factor of Graft Versus Leukaemia Effect in Patients Who Received an Allograft

NCT07271498 | Completed

• 1 other identifier: 25Hemato01
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Allografts; Oral cGVHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Disease free survival,

  3 months, 6 months, 1 years and 1,5 years

• Non relapse mortality

  3 months, 6 months, 1 years and 1,5 years

Study Arms (1)

Patient with oral cGVHD

Other: Evaluation of oral cGVHD

Interventions

Evaluation of oral cGVHD OTHER

analysis statistics

Patient with oral cGVHD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients who did not received an allograft

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, Alpes Maritimes, 06000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 9, 2025
• Study Start: October 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-11

Locations

FR (1)