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OpenTrials
Completed

NCT Number: NCT07271498

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

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.

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Key information

Conditions

Allografts Oral cGVHD

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de NICE

Nice, Alpes Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of oral cGVHD

Other

analysis statistics

Primary outcomes

  1. Overall survival

    Time frame: 3 months, 6 months, 1 years and 1,5 years

    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

  1. Disease free survival,

    Time frame: 3 months, 6 months, 1 years and 1,5 years

    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.

  2. Non relapse mortality

    Time frame: 3 months, 6 months, 1 years and 1,5 years

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

"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"

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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