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

CHU de Nantes0 sitesMarch 11, 2010

Overview

No summary available.

Registry

who.int

Start Date

March 11, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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.

•\- 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