Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-Cell Angioimmunoblastic Lymphoma (AIL).
This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy
and the safety of a front-line treatment combining CHOP regimen and rituximab in patients
aged 60 to 80 years with previously untreated AIL.
It is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis
performed every 5 patients (based on triangular test).
The duration of the treatment period is approximately 25 weeks and patients are followed
The total Duration of the study is expected to be 2.5 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR) [Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment.
Corinne Haioun, MD
Hôpital Henri Mondor, Créteil, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)