A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma

Roche

Status and phase: Completed; Phase 3

Conditions: Lymphoma

Treatments: Drug: rituximab; Drug: interferon-a-2a

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT01609010

ML16865

Details and patient eligibility

About

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.

Enrollment: 313 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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313 participants in 2 patient groups

Rituximab Monotherapy

Active Comparator group

Description:

Participants received 375 milligrams per square meter (mg/m2) rituximab intravenously (i.v.) weekly for 4 weeks. Participants achieving minor response (MR), partial response (PR), or completer response (CR) received a second cycle of treatment.

Treatment:

Drug: rituximab

Rituximab, Interferon

Experimental group

Description:

Participants received 375 mg/m2 rituximab i.v. weekly for 4 weeks; and 3 million international units per day (MIU/day) interferon-a2a subcutaneously (s.c.) during Week 1, and 4.5 MIU/day s.c. 6 days per week during Weeks 2 through 5. Interferon-a2a was not administered on days of rituximab administration. Participants achieving MR, PR, or CR received a second cycle of treatment.

Treatment:

Drug: interferon-a-2a

Drug: rituximab