Status:
COMPLETED
Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab (Protocol R-GVHD)
Lead Sponsor:
Nantes University Hospital
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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 :
- Ocular, oral and mucosal symptoms,
- Performance status evaluation,
- Pulmonary function evaluation,
- Cutaneous evaluation measured by the percentage of extension of manifestations of liche-noid or sclerodermatous aspects, eventually confirmed with a biopsy whenever possible,
- Evaluation of the musculoskeletal manifestations, especially the amplitude of the rele-vant articulations,
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01135641
Start Date
June 1 2010
End Date
March 1 2014
Last Update
April 3 2014
Active Locations (1)
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1
Nantes University Hospital
Nantes, France, 44093