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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Study Association
• Treatments: Rituximab

Criteria

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.