Chronic graft versus host disease MedDRA version: 12.1 Level: LLT Classification code 10066261 Term: Chronic graft versus host disease
Conditions
Interventions
Trade Name: Mabthera
Pharmaceutical Form: Solution for infusion
Trade Name: Mabthera
Pharmaceutical Form: Solution for infusion
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ciclosporine
I
Sponsors
CHU de Nantes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients (=18 years) who have received a first allogeneic stem cell transplantation for a hematological disease - Confirmed diagnosis of first episode of chronic GVHD requiring systemic immunosuppres-sive therapy. Chronic GVHD diagnosis is defined according to the NIH Working Group Con-sensus. Chronic GVHD diagnosis will be based on the evaluation of the severity of the differ-ent clinical manifestations including : a/ Occular, oral and mucosal symptoms, b/ Performance status evaluation, c/ Pulmonary function evaluation, d/ Cutaneaous evaluation measured by the percentage of extension of manifestations of liche-noid or sclerodermatous aspects, eventually confirmed with a biopsy whenever possible, e/ Evaluation of the musculo-squelettal manifestations, especially the amplitude of the relevant articulations, f/ Evaluation of liver involvement (Total bilirubin, Transaminases, Phosphatase alcalines and Gamma GT). - Any source of hematopoietic stem cells is authorized. - Any category of conditioning regimen prior to allo-SCT is authorized. - Any type of stem cell donors is authorized. - Signed informed consent. - Any prior GVHD prophylaxis previously used is accepted. - Absence of contra-indications to the use of Rituximab. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient developing acute GVHD (whether early or “late onset” form) - A “limited” form of chronic GVHD not requiring systemic immunosuppressive therapy - Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment. Persistent prednisone treatment of acute GVHD that is less than 1mg/kg is allowed (i.e. Patient was treated for acute GVHD with prednisone, and developed chronic GVHD before completing taper). - GVHD occurring following donor lymphocytes infusion (DLI) - Not the first episode of chronic GVHD needing systemic immunosuppressive therapy - Neutropenia <500/µL - Second allogeneic stem cell transplant - Uncontrolled systemic infection which in the opinion of the investigator is associated with an increased risk of the patient’s death within 1 month after the start of therapy - Severe neurological or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of response rate (complete and partial remission) of chronic GVHD at 12 months after diagnosis of chronic GVHD and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.;Primary end point(s): Evaluation of response rate (complete and partial remission) of chronic GVHD at 12 months after diagnosis of chronic GVHD and treatment with the combination of cyclosporine, predni-sone and Rituximab as first line treatment.;Secondary Objective: - Corticosteroids dosage and percentage of reduction in corticosteroids dosage at 12 months after diag-nosis of chronic GVHD and treatment with the combination of cyclosporine, prednisone and Rituximab as first line treatment. - Percentage of patients with documented treatment failure-defined as initiation of another immuno-suppressive agent - Cumulative incidence of transplant-related mortality (TRM) of infectious and non-infectious origin at 12 months after diagnosis of chronic GVHD and treatment with the combination of cyclosporine, prednisone and Rituximab as first line treatment. - Descriptive analysis of quality of life parameters at inclusion, at 6 weeks, and at 3, 6, 9 and 12 months after diagnosis of chronic GVHD and treatment with the combination of cyclosporine, prednisone and Rituximab as first line treatment. | — |
Countries
France
Outcome results
None listed