An Open-Label, Multicenter, Randomized Study in Previously Untreated Follicular Lymphoma Patients to Evaluate the Efficacy of Consolidation With Zevalin® Versus Maintenance Treatment With Rituximab After Initial Therapeutic Response to Rituximab Plus Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 5
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to evaluate the effect of consolidation treatment Zevalin® versus maintenance treatment with Rituxan® on progression-free survival (PFS) following response induction with chemotherapy plus rituximab in previously untreated participants with follicular lymphoma.
详细描述
This is an open-label, multicenter and randomized study. Participants registered after response induction (PR/CR) to R-chemotherapy. Participants achieving either a partial response (PR) or complete response (CR) following R-chemotherapy eligible for randomization to either consolidation with 90Y-ibritumumab tiuxetan followed by observation for 24 months, or rituximab maintenance for 24 months. After the observation/maintenance period, patients follow up for 5 years.
This study was terminated early for business reasons. (Maximum duration of study was up to approximately 2.7 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years of age.
- •Previously untreated with histologically confirmed grade 1, 2 or 3a cluster of differentiation-20 (CD20)-positive follicular lymphoma, with any of the GELF (Groupe d'Etude de Lymphomes Folliculaires) treatment criteria prior to induction.
- •Achieved a response to induction treatment with either rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (6 cycles of R-CHOP21 or R-CHOP14), rituximab-cyclophosphamide, vincristine and prednisone (R-CVP) (6 cycles), or rituximab-bendamustine (R-B) (4 to 6 cycles).
- •Must have completed all doses of the induction treatment, except for the modifications allowed in the protocol.
排除标准
- •Transformation to high grade lymphoma (secondary to "low grade" follicular lymphoma [FL]).
- •Grade 3b follicular lymphoma.
- •Primary follicular lymphoma of the skin or gastrointestinal tract.
- •Previous treatment of follicular lymphoma.
- •Altered renal and hepatic function.
- •Known human immunodeficiency virus (HIV) infection and/or active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
- •Serious co-morbid conditions (for example, ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
- •Life expectancy <
- •Must have:
- •Platelet count ≥ 100x10^9/L.
- •Bone marrow infiltration <25%.
研究组 & 干预措施
Zevalin Regimen Consolidation (Group A)
90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight >80 kg: 1,184 MBq [32 mCi] maximum dose).
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months).
干预措施: Zevalin (Drug)
Zevalin Regimen Consolidation (Group A)
90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight >80 kg: 1,184 MBq [32 mCi] maximum dose).
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months).
干预措施: Rituximab (Drug)
Rituximab Maintenance (Group B)
Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).
干预措施: Rituximab (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Up to approximately 2.7 months
Progression-free survival (PFS) is defined as the time from randomization until progression, relapse, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiation therapy or immunotherapy).
次要结局
- Time to Progression (TTP)(Up to approximately 2.7 months)
- Transformation at First Progression(Up to approximately 2.7 months)
- Number of Participants With Secondary Malignancies(Up to approximately 2.7 months)
- Functional Assessment of Cancer - General (FACT-G)(Up to approximately 2.7 months)
- Pharmacoeconomics (Cost Effectiveness Analysis)(Up to approximately 2.7 months)
- Time to Next Anti-Lymphoma Treatment (TTNLT)(Up to approximately 2.7 months)
- Overall Response Rate (ORR)(Up to approximately 2.7 months)
- Number of Participants With Toxicity(Up to approximately 2.7 months)
- Complete Response Rate(Up to approximately 2.7 months)
- European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)(Up to approximately 2.7 months)
- Event Free Survival(Up to approximately 2.7 months)
- Overall Survival (OS)(Up to approximately 2.7 months)
- Time to Next Chemotherapy (TTNCT)(Up to approximately 2.7 months)