The main objective of the study is to improve the response rate (complete and partial remission) at 12 months after diagnosis of chronic Chronic Graft Versus Host Disease (GVHD) and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Patients will receive in addition to ciclosporine A and corticosteroids (prednisone) 1 mg/kg/day, Rituximab at 375 mg/m²/infusion once a week for 4 consecutive weeks.
Nantes University Hospital
Nantes, France
Response rate at 12 months
Response rate (complete and partial remission) at 12 months after diagnosis of chronic GVHD and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.
Number of participants with adverse events as a measure of safety and tolerability
To spare patients from long-term use of corticosteroids (and of their long-term side effects)
Treatment failure
To document treatment failure-defined as initiation of another immunosuppressive agent
Transplant-related mortality
To decrease transplant-related mortality (TRM) of infectious and non-infectious origin
Quality of life
To improve quality of life parameters
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