A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 572
- 试验地点
- 186
- 主要终点
- Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)
研究概览
简要总结
This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/= 18 and </= 80 years of age at time of study inclusion
- •Histologically confirmed, previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) according to the WHO classification system
- •Patients with an International Prognostic Index (IPI) score 1-5, or IPI score 0 with bulky disease, defined as one lesion >/= 7.5 cm
- •At least one bi-dimensionally measurable lesion defined as >/= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI
- •Adequate hematologic function
- •Eastern Cooperative Oncology Group (EOCD) performance status </= 2
排除标准
- •Primary or secondary central nervous system lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis
- •Transformed lymphoma or follicular lymphoma IIIB
- •Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
- •History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for >/= 5 years prior to enrolment
- •Inadequate renal or hepatic function
- •Known human immunodeficiency virus (HIV) infection or HIV seropositive status
- •Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients with occult or prior HBV infection as defined by protocol may be included. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing for HCV ribonucleic acid is negative.
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- •Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
- •Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
- •Pregnant or lactating women
研究组 & 干预措施
A: Rituximab SC
干预措施: CHOP (Drug)
A: Rituximab SC
干预措施: rituximab [MabThera/Rituxan] (Drug)
B: Rituximab IV
干预措施: CHOP (Drug)
B: Rituximab IV
干预措施: rituximab [MabThera/Rituxan] (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)
时间窗: Up to approximately 4.25 years
Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (\>) 75 percent (%) but still \>1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI).
次要结局
- Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores(At Cycle 7 (each cycle was 14 or 21 days))
- Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle(Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days))
- Number of Participants With Relapse or Death at the Time of Primary Analysis(Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination))
- Number of Deaths(Up to approximately 4.25 years)
- Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores(At Cycle 7 (each cycle was 14 or 21 days))
- Median Duration of Rituximab Administration for Each Treatment Cycle(Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days))
- Number of Participants With an Event-Free Survival (EFS) Event(Up to approximately 4.25 years)
- Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle(Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days))
- Duration of EFS(Up to approximately 4.25 years)
- Duration of Disease-Free Survival (DFS)(Up to approximately 4.25 years)
- Number of Participants With Progression, Relapse, or Death(Up to approximately 4.25 years)
- Duration of Progression-Free Survival (PFS)(Up to approximately 4.25 years)
- Duration of Overall Survival (OS)(Up to approximately 4.25 years)