FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Event free survival
Gilles A Salles, MD PhD
Principal Investigator
Lymphoma Study Association
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
FL2000
NCT00136552
May 2000
December 2004
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