Rituximab (Mabthera®) as Single Agent and in Combination With Interferon Alfa-2a (Roferon-A®), a Phase-III Randomized Trial in Patients With Follicular or Other CD20+ Low-grade (Indolent) Lymphoma
Inclusion Criteria:
- Adult patients >18 years of age
- CD20+ low-grade (indolent) lymphoma of follicular and marginal zone type, small
lymphocytic lymphoma without a B-CLL phenotype, or indolent lymphoma not otherwise
specified
- Stage II (with bulky disease), III, or IV lymphoma
- No previous chemotherapy or a maximum of 6 months chlorambucil or cyclophosphamide
- Indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma
manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or
thrombocytopenia or decreased hemoglobin or platelets due to lymphoma, general
symptoms (weight loss, night sweats or fever)
- WHO performance status 0-2
Exclusion Criteria:
- Prior treatment with rituximab or an interferon
- B-CLL, mantle cell lymphoma, lymphoplasmacytic lymphoma (Waldenstroem's disease), or
central nervous system lymphoma
- Indolent lymphoma transformed into aggressive lymphoma
- Indolent lymphoma with bulky tumor requiring urgent therapy
- Prior malignancies, except non-melanoma skin tumors, in situ cervical cancer, or
curative surgery >5 years ago
- Positive for HIV infection
- Uncontrolled asthma or allergy requiring corticosteroids