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