Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab (Protocol R-GVHD)

Graft Versus Host Disease Clinical Trial

— R-GVHD  

Official title:

Phase II Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135641
• Other study ID #: 09/6-B
• Secondary ID: 2009-016898-14
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2010
• Last updated: April 2, 2014
• Start date: June 2010
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : AFSSAPS
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 immunosuppressive therapy. Chronic GVHD diagnosis is defined according to the NIH Working Group Consensus. Chronic GVHD diagnosis will be based on the evaluation of the severity of the different clinical manifestations including :

1. Ocular, oral and mucosal symptoms,

2. Performance status evaluation,

3. Pulmonary function evaluation,

4. Cutaneous evaluation measured by the percentage of extension of manifestations of liche-noid or sclerodermatous aspects, eventually confirmed with a biopsy whenever possible,

5. Evaluation of the musculoskeletal manifestations, especially the amplitude of the rele-vant articulations,

6. 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.

• Subjects affiliated with an appropriate social security system.

• Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 3 months following the end of the study.

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.

• 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

• Denied informed consent

• Pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• Rituximab
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.
• Ciclosporine

• Corticosteroids

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	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)		No
Secondary	Treatment failure	To document treatment failure-defined as initiation of another immunosuppressive agent		No
Secondary	Transplant-related mortality	To decrease transplant-related mortality (TRM) of infectious and non-infectious origin		No
Secondary	Quality of life	To improve quality of life parameters		No