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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 313
- 主要终点
- Treatment Failure - Time to Event
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Rituximab Monotherapy
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.
干预措施: rituximab (Drug)
Rituximab, Interferon
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.
干预措施: rituximab (Drug)
Rituximab, Interferon
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.
干预措施: interferon-a-2a (Drug)
结局指标
主要结局
Treatment Failure - Time to Event
时间窗: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
The median time, in months, between randomization and treatment failure event determined using Kaplan-Meier estimates.
Treatment Failure - Percentage of Participants With an Event
时间窗: Baseline (BL), Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
Treatment failure was defined as an event of any of the following: progressive disease while receiving study treatment, death due to any cause, or the initiation of another type of treatment due to stable disease, progressive disease or relapse, or intolerance to study treatment.
次要结局
- Percentage of Participants Achieving Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)(Weeks 10 and 16)
- Overall Survival (OS) - Percentage of Participants With an Event(BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period)
- Percentage of Participants Achieving CR or CRu(Weeks 10 and 16)
- Time to Disease Progression(BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period)
- Duration of Response - Percentage of Participants With an Event(BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period)
- Disease Progression - Percentage of Participants With an Event(BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period)
- Overall Survival(BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period)
- Duration of Response(BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period)