A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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).

Conditions
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Untreated T-cell Angioimmunoblastic Lymphoma

Intervention / Treatment
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* Drug: Rituximab
* Drug: Prednisone
* Drug: Doxorubicine
* Drug: Cyclophosphamide
* Drug: Vincristine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab + CHOP<br>Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine | Drug: Rituximab<br>* 375 mg/m2 D1<br>Drug: Prednisone<br>* 40 mg/m2 D1 to D5<br>Drug: Doxorubicine<br>* 50 mg/m2 D1<br>Drug: Cyclophosphamide<br>* 750 mg/m2 D1<br>Drug: Vincristine<br>* 1,4 mg/m2 D1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | [Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment. | 8 months (4 cycles of treatment + 4 cycles of consolidation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 
| Overall survival (OS) |  | 2 years | 
| Time to progression (TTF) |  | 2 years | 
| Disease-free survival (DFS). |  | 2 years | 
| number of SAE |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T-cell angioimmunoblastic lymphoma, Rituximab