NCT00136552

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (planned)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	rituximab

Timeline

• Start date: 2000-05-01
• Completion: 2004-12-01
• First posted: 2005-08-29
• Last updated: 2007-07-03

Locations

5 sites across 2 countries: Belgium, France