Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to define an improvement and theassessment of the Time to Treatment Failure in patients randomized in three different arms: R-CVP vs R-CHOP vs R-FM.

Detailed Description
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Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP - Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.

Official Title
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Phase III Multicentric IIL Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Treatment of Patients With Stage II-IV Follicular Lymphoma

Conditions
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Follicular Lymphoma

Intervention / Treatment
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* Drug: R-CVP
* Drug: R-CHOP
* Drug: R-FM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological DIAGNOSIS of B cell follicular lymphoma ECOG performance status 0-2 Age range 18-75 Ann Arbor Stage: II-IV Assessment of pathology with diagnostics biopsy Presence of one of these criteria: B Sistemic symptoms B Extranodale pathology Cytopenia Splenomegaly Leukemia Serous effusion Ves > 20 mm/h Ldh > normal value Nodale or extranodal mass > 7 cm 3 or more nodal sites > 3 cm Adenopatic syndrome LVEF > 50% Normal hepatic (bilirubin < 1.5 mg/dl) and renal functionality (creatinin < 2 mg/dl). If there is a lymphoma it's allow values of bilirubin > 1.5 mg/dl and of creatinin > 2mg/dl No previous treatment for follicolar lymphoma unless RT-IF Lifetime > 6 mounth Absence of HbsAg, HCV e HIV Negative Coombs Test Negative pregnant test Cotracceptive method during the treatment and the follow three months Formal written consent Ability to follow the patients after the treatment for follow up Exclusion Criteria: Histological Diagnosis of all type of lymphoma unless Follicularlymphoma, CD20 lymphoma, stage IIIb of follicular lymphoma and high degree lymphoma Stage I of Ann Arbor scale Central Nervous system involvement HIV, HBV OR HCV Positivity Cardiac Pathology Positive Coombs Test Previous chemotherapeutic treatment Hypersensitivity to antibodyes or other murine proteins Previous cancer pathology unless in situ cervix and epithelial carcinomas Other type of infections Pregnant and nursing woman

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>R-CVP x 3; Restaging if> RP then R-CVP x 5 | Drug: R-CVP<br>* Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1, Vincristina: 1,4 mg/mq day 1 Prednisone: 40 mg/mq day 1-5,<br>|
| Experimental: 2<br>R-CHOP x 3; Restaging if > RP then R-CHOP x 3 plus 2 Rituximab | Drug: R-CHOP<br>* Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1 Doxorubicina: 50 mg/mq day 1 Vincristina: 1.4 mg/mq day 1 Prednisone: 100 mg/mq day 1-5<br>|
| Experimental: 3<br>R-FM x 3; Restaging if > RP then R-FM x 3 plus 2 Rituximab | Drug: R-FM<br>* Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. - |  | 3 years | 
| Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP |  | 2 years | 
| Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. |  | 2 years | 
| Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. |  | 2 years | 
| Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. |  | 2 years | 
| Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Follicular lymphoma, Rituximab