A MULTI-CENTER LONG-TERM FOLLOW-UP STUDY OF PATIENTS WITH LOW-GRADE NON-HODGKIN'S LYMPHOMA PREVIOUSLY TREATED WITH TOSITUMOMAB AND/OR IODINE I 131 TOSITUMOMAB IN STUDIES RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004, or CP-97-012
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- None - Administrative non interventional study to obtain long term safety and efficacy data.
研究概览
简要总结
This is a study for the long-term follow-up of patients who completed at least two years of follow-up after treatment with Tositumomab and/or Iodine I 131 Tositumomab (BEXXAR)on Study RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004 or CP-97-012. All patients will be assessed for survival and disease status, including subsequent therapy for NHL, and for long term safety. Laboratory evaluations consisting of a TSH level (for all patients) and a complete blood cell (CBC) count with a differential and platelet count (for patients in continuing response only) will be obtained annually through Year 10 post treatment with Tositumomab and/or Iodine I 131 Tositumomab.
Patients that remain in response to their previous treatment with BEXXAR, will additionally be followed radiographically for response and progression.
研究设计
- 研究类型
- Observational
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
- •Patients must have enrolled in one of the following Corixa sponsored clinical trials: RIT-I-000, RIT-II-001, RIT-II-002, RIT II-004 or CP-97-012 and are >2 years post Tositumomab and/or Iodine I 131 Tositumomab administration.
- •Patients must give written informed consent by signing an IRB/ethics committee approved consent form prior to entry on this follow-up study.
排除标准
- •Inability to meet the above referenced inclusion criteria.
结局指标
主要结局
None - Administrative non interventional study to obtain long term safety and efficacy data.
时间窗: Subjects enrolled in Study BEX104526 were followed for continued response (as applicable) and safety every 6 months for Years 3 through 5 post-treatment with TST/I-131 TST. Beginning at Year 6, subjects were assessed annually through Year 10 inclusive.
Study BEX104526 (formerly Corixa Study CCBX001-051) was designed to obtain long-term safety and efficacy data from the surviving subjects who completed at least 2 years of follow-up following administration of TST/I-131 TST while on Study BEX104728 (RIT-I-000), BEX104731 (RIT-II-001), BEX104504 (RIT-II-004), BEX104515 (RIT-II-002), or BEX104507 (CP-97-012). Analyses will be performed according to one of the five primary interventional protocols.
次要结局
未报告次要终点