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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Hôpital Henri Mondor
Créteil, France
Hôpital Saint Louis
Paris, France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
Centre Henri Becquerel
Rouen, France
Overall Response Rate (ORR)
\[Complete response (CR), Complete response unconfirmed (CRu)\] after the end of treatment.
Time frame: 8 months (4 cycles of treatment + 4 cycles of consolidation)
Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.
Events being death from any cause
Time frame: 2 years
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
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750 mg/m2 D1
1,4 mg/m2 D1