Copanlisib in Indolent Non-Hodgkin Lymphoma Patients: A Real-world Taiwan Observation Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Dose regimes
研究概览
简要总结
This is an observational study, in which data from Taiwanese people with indolent non-Hodgkin lymphoma who will be receiving copanlisib is studied.
Indolent non-Hodgkin lymphoma (iNHL) is a type of cancer that grows and spread slowly and begins in the lymphatic system, which is a part of body's immune system, and affects a type of white blood cells called lymphocytes of. In iNHL, white blood cells grow abnormally and can form growths (tumors) throughout the body. iNHL tends to come back after treatment (relapse) and may stop to respond to medical treatment (become refractory). While the disease is typically slow growing, it can become more aggressive over time. iNHL consists of multiple subtypes and it is already known to the researchers that Taiwanese people often have a different subtype of iNHL and poorer survival than people in most Western countries. Moreover, there is little information about how well the drug copanlisib works in Asian people with iNHL.
The study drug copanlisib works by blocking PI3K proteins and preventing cancer cells from growing and surviving. Copanlisib is already available in US and in Taiwan and is approved for doctors to prescribe to patients.
The National Authority for Health in Taiwan granted an accelerated approval of copanlisib due to the new mechanism of action of this drug and based on the results of a previous study, in which participants with iNHL received treatment with copanlisib. This previous study, however, included only a small number of Asian people and no Taiwanese people at all.
The main purpose of this study is to learn more about treatment patterns of copanlisib from Taiwanese people who have decided with their doctor to start copanlisib for iNHL.
To do this, researchers will collect the following data:
- administered doses of copanlisib
- dates of treatment administration
- how long copanlisib treatment was given
- the number of treatment periods also called cycles (one cycle is defined as 3 intravenous treatments in 3 of 4 weeks)
- dates and reasons of copanlisib treatment interruption
- dates and reasons of copanlisib treatment discontinuations. In addition, researchers will also look at how well copanlisib works in these people.
There are no required visits to the study site. The participants will receive their treatments as agreed with their doctors. The data will be gathered from the medical charts of the participants with iNHL who will receive copanlisib or received at least one dose of copanlisib after 01-Nov-2019. The data collection will cover the time between the date with the first diagnosis of iNHL and 01-May-2024 or earlier if the data collection of maximal 50 participants is completed before 01-May-2024.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 with confirmed diagnosis of r/r iNHL
- •Patients ages ≥ 18 years old when first dosed with copanlisib for iNHL.
- •Patients who will receive copanlisib or received at least one dose of copanlisib after 01-Nov-2019
- •Patients or his/her legal guardian or representative agree to provide the written informed consent or a waiver of informed consent granted by local IRB
排除标准
- •Patients who had participated in the global clinical study for copanlisib before local market approval
- •Patients who participate in an interventional trial during the data collection period
研究组 & 干预措施
r/r iNHL Patients: Copanlisib treatment
The data in patients who received at least one dose of copanlisib before 01-May-2022 will be included for interim analysis. All study data collection will end in Q2 2024, or when the data collection of maximal 50 enrolled patients is completed, whenever comes first.
Subgroup analysis: r/r iNHL Patients: Copanlisib 2nd line treatment Subgroup analysis: r/r iNHL Patients: Copanlisib 3rd line treatment
干预措施: Copanlisib (BAY80-6946) (Drug)
结局指标
主要结局
Dose regimes
时间窗: Approximately up to 27 month
The treatment regimens of copanlisib including the reasons of copanlisib interruption within a cycle and discontinuation, if available, will be summarized by listing and presented as count and percentage if applicable.
Treatment duration
时间窗: Approximately up to 27 month
The treatment regimens of copanlisib including the reasons of copanlisib interruption within a cycle and discontinuation, if available, will be summarized by listing and presented as count and percentage if applicable.
Number of treatment cycles
时间窗: Approximately up to 27 month
The treatment regimens of copanlisib including the reasons of copanlisib interruption within a cycle and discontinuation, if available, will be summarized by listing and presented as count and percentage if applicable. Three intravenous infusions of copanlisib dosing in a 28-day intermittent treatment schedule (i.e., 3 weeks on and 1 week off) will be regarded as a treatment cycle.
Reasons of discontinuations
时间窗: Approximately up to 27 month
The treatment regimens of copanlisib including the reasons of copanlisib interruption within a cycle and discontinuation, if available, will be summarized by listing and presented as count and percentage if applicable.
次要结局
- Type of treatment response(From baseline to the end of each copanlisib treatment cycle (Three intravenous infusions of copanlisib dosing in a 28-day intermittent treatment schedule (i.e., 3 weeks on and 1 week off) will be regarded as a treatment cycle))
- Time to response(From baseline to the end of each copanlisib treatment cycle (Three intravenous infusions of copanlisib dosing in a 28-day intermittent treatment schedule (i.e., 3 weeks on and 1 week off) will be regarded as a treatment cycle))
- Ann Arbor stage of the first diagnosis of iNHL(Approximately up to 27 month)
- Progression status after the first dose of copanlisib(From baseline to the end of each copanlisib treatment cycle (Three intravenous infusions of copanlisib dosing in a 28-day intermittent treatment schedule (i.e., 3 weeks on and 1 week off) will be regarded as a treatment cycle))
- Previous treatment regimens(Approximately up to 27 month)
- Change in laboratory data, including hemoglobin A1c (HbA1c) values(From baseline to the end of each copanlisib treatment cycle (Three intravenous infusions of copanlisib dosing in a 28-day intermittent treatment schedule (i.e., 3 weeks on and 1 week off) will be regarded as a treatment cycle))
- Duration of response (DoR)(From baseline to the end of each copanlisib treatment cycle (Three intravenous infusions of copanlisib dosing in a 28-day intermittent treatment schedule (i.e., 3 weeks on and 1 week off) will be regarded as a treatment cycle))
- Time to progression(From baseline to the end of each copanlisib treatment cycle (Three intravenous infusions of copanlisib dosing in a 28-day intermittent treatment schedule (i.e., 3 weeks on and 1 week off) will be regarded as a treatment cycle))
- Largest change in target lesion size as judged by physicians(From baseline to the end of each copanlisib treatment cycle (Three intravenous infusions of copanlisib dosing in a 28-day intermittent treatment schedule (i.e., 3 weeks on and 1 week off) will be regarded as a treatment cycle))
- Number of patients with treatment-emergent AEs(Approximately up to 27 month)
- Subsequent therapeutic options for treating iNHL post discontinuation of copanlisib(Approximately up to 27 month)