A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma
|ClinicalTrials.gov Identifier: NCT00169156|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Untreated T-cell Angioimmunoblastic Lymphoma||Drug: Rituximab Drug: Prednisone Drug: Doxorubicine Drug: Cyclophosphamide Drug: Vincristine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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).|
|Actual Study Start Date :||December 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||November 2012|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|