A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma
|Untreated T-cell Angioimmunoblastic Lymphoma||Drug: Rituximab Drug: Prednisone Drug: Doxorubicine Drug: Cyclophosphamide Drug: Vincristine||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
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) [ Time Frame: 8 months (4 cycles of treatment + 4 cycles of consolidation) ][Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment.
- Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment. [ Time Frame: 2 years ]Events being death from any cause
- Overall survival (OS) [ Time Frame: 2 years ]
- Time to progression (TTF) [ Time Frame: 2 years ]
- Disease-free survival (DFS). [ Time Frame: 2 years ]
- number of SAE [ Time Frame: 2 years ]
|Actual Study Start Date:||December 2005|
|Study Completion Date:||November 2012|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Rituximab + CHOP
Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
375 mg/m2 D1Drug: Prednisone
40 mg/m2 D1 to D5Drug: Doxorubicine
50 mg/m2 D1Drug: Cyclophosphamide
750 mg/m2 D1Drug: Vincristine
1,4 mg/m2 D1
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169156
|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|