A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma
A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma
This randomized, open-label study will compare the efficacy and safety of MabThera/Rituxan
 (rituximab) alone, and in combination with Roferon-A (interferon alfa-2a) in patients with
 follicular or other CD20+ low-grade lymphoma. Patients will be randomized to receive either
 MabThera/Rituxan 375 mg/m2 intravenously weekly for 4 weeks or Roferon-A 3 MIU/day
 subcutaneously in Week 1 followed by 4.5 MIU/day sc in Weeks 2-5 plus MabThera/Rituxan 375
 mg/m2 weekly iv in Weeks 3-6. Patients who have a response will receive an additional cycle
 of treatment. The anticipated time on study treatment is up to 6 months.
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