A Phase II Study of Rituximab Combined With CHOP in T-Cell Angio-Immunoblastic Lymphoma
Recruitment status was Active, not recruiting
To evaluate 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.
Untreated T-Cell Angioimmunoblastic Lymphoma
Drug: Rituximab + CHOP regimen
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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).|
- Overall Response Rate (ORR) [Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment.
- - Event-free survival (EFS) at 2 years: events being death from any cause, relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.
- - Overall survival (OS), time to progression (TTF) and disease-free survival (DFS).
- - Safety of R-CHOP in this patient's population.
- - Correlation between response rate, survival and biological informations (phenotype, EBV status, T/B clonality).
- - Biological studies.
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||December 2009|
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 until Death.
The total Duration of the study is expected to be 2.5 years.
|Hôpital Henri Mondor|
|Hôpital Saint Louis|
|Service d'Hématologie - Centre Hospitalier Lyon-Sud|
|Pierre-Bénite cedex, France, 69495|
|Centre Henri Becquerel|
|Study Chair:||Corinne Haioun, MD||Hôpital Henri Mondor, Créteil, France|
|Principal Investigator:||Bertrand Joly, MD||C.H. Sud Francilien, Corbeil-Essonnes, France|