Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden

Study Overview
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Brief Summary
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The purpose of this study is to assess in a prospective multicentric study (Phase III) the introduction of a monoclonal antibody directed against B-cells associated with a standard therapy including chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma.

Detailed Description
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Follicular lymphoma patients with a large tumor burden will be randomized for 18 months of treatment with either: Arm A: CHVP + alpha2a-interferon. Patients will receive 12 courses of CHVP (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and prednisolone 40 mg/m² for 5 days), one course every month for 6 months then one course every other month for 12 additional months associated with alpha2a-interferon 4.5 millions units sub-cutaneously three times a week for 18 months. Arm B: CHVP + alpha2a-interferon + rituximab. Patients will receive 6 monthly courses of CHVP (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and prednisolone 40 mg/m² for 5 days) associated with 6 infusions of rituximab (375 mg/m2) associated with alpha2a-interferon 4.5 millions units sub-cutaneously three times a week for 18 months.

Official Title
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FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed follicular lymphoma with a biopsy performed in the last 3 months Patients previously untreated. Patients with at least one of the following symptoms requiring initiation of treatment: Bulky disease at study entry according to the Groupe d'Etudes Lymphomes Folliculare (GELF) criteria: nodal or extranodal mass > 7cm in its greater diameter B symptoms Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 1 Elevated serum lactate dehydrogenase (LDH) or beta2-microglobulin Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm) Symptomatic splenic enlargement Compressive syndrome Pleural/peritoneal effusion Age must be > 18 years and less than 76 years Having previously signed a written informed consent form. Exclusion Criteria: Transformation to high-grade lymphoma (secondary to low-grade follicular lymphoma). Patients without a large tumor burden. Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer. Poor renal function: Serum creatinine > 150 μmol/L, Known HIV infection or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with contra-indication to interferon, adriamycin, or rituximab. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). Judgment is up to the investigator. Known sensitivity or allergy to murine products Adult 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rituximab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphoma, follicular, B-cell, rituximab, interferon