A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma
- Conditions
- Untreated T-cell Angioimmunoblastic Lymphoma
- Interventions
- Registration Number
- NCT00169156
- Lead Sponsor
- Lymphoma Study Association
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- Patients with histologically proven T-cell angioimmunoblastic lymphoma (AIL) on lymph node biopsy.
- Aged from 60 to 80 years.
- Patient not previously treated (except corticosteroids providing they have been initiated less than 10 days before inclusion).
- ECOG performance status 0 to 2.
- With a minimum of life expectancy > 3 months.
- Negative HIV, HBV and HCV serological tests < 4 weeks (except after vaccination).
- Having previously signed a written informed consent.
- Any other histological type of T-cell lymphoma.
- Central nervous system or meningeal involvement by lymphoma.
- Contra-indication to any drug included in the R-CHOP regimen.
- Concurrent severe disease (according to the investigator's decision).
- Active bacterial, viral or fungal infection.
- Poor renal function (serum creatinine level > 150 µmol/L) or impaired liver function tests (total bilirubin level > 30 µmol/L, transaminases > 2.5 upper normal limits) unless they are related to the lymphoma.
- Poor bone marrow reserve as defined by neutrophils < 1.5 x 109/L or platelets < 100 x 109/L, unless related to bone marrow infiltration.
- Any history of cancer during the last 5 years, with the exception of non basal cell carcinoma of the skin or in situ carcinoma of the cervix.
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- Patient under tutelage.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rituximab + CHOP Rituximab Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine Rituximab + CHOP Prednisone Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine Rituximab + CHOP Doxorubicine Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine Rituximab + CHOP Cyclophosphamide Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine Rituximab + CHOP Vincristine Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) 8 months (4 cycles of treatment + 4 cycles of consolidation) \[Complete response (CR), Complete response unconfirmed (CRu)\] after the end of treatment.
- Secondary Outcome Measures
Name Time Method Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment. 2 years Events being death from any cause
number of SAE 2 years Disease-free survival (DFS). 2 years Overall survival (OS) 2 years Time to progression (TTF) 2 years
Trial Locations
- Locations (4)
Hôpital Henri Mondor
🇫🇷Créteil, France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
🇫🇷Pierre-Bénite cedex, France
Centre Henri Becquerel
🇫🇷Rouen, France
Hôpital Saint Louis
🇫🇷Paris, France