Phase II study of first line treatment of chronic graft versus host disease with the association of ciclosporine, corticosteroids and Rituximab - R-GVHD

• Conditions: Chronic graft versus host disease; MedDRA version: 12.1Level: LLTClassification code 10066261Term: Chronic graft versus host disease

• Registration Number: EUCTR2009-016898-14-FR
• Lead Sponsor: CHU de Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified