Clinical trial NCT05217914: A Study to Learn More About Copanlisib Treatment Patterns in People With Indolent Non-Hodgkin Lymphoma, a Type of Cancer That Grows and Spread Slowly and Develops in the Lymphatic System (a Part of Immune System) in Taiwan Under Real-word Conditions
Official title: Copanlisib in Indolent Non-Hodgkin Lymphoma Patients: A Real-world Taiwan Observation Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsed or Refractory Indolent Non-Hodgkin Lymphoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-02-01
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible r/r iNHL patients who will receive copanlisib or received at least one dose of copanlisib after 01-Nov-2019 and agreed to provide the written informed consent or a waiver of informed consent granted by local IRB.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Dose regimes
timeFrame: Approximately up to 27 month
measure: Treatment duration
timeFrame: Approximately up to 27 month
measure: Number of treatment cycles
timeFrame: Approximately up to 27 month
measure: Reasons of discontinuations
timeFrame: Approximately up to 27 month
Secondary outcomes:
measure: Ann Arbor stage of the first diagnosis of iNHL
timeFrame: Approximately up to 27 month
measure: Previous treatment regimens
timeFrame: Approximately up to 27 month
measure: Type of treatment response
timeFrame: 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)
measure: Duration of response (DoR)
timeFrame: 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)
measure: Time to response
timeFrame: 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)
measure: Progression status after the first dose of copanlisib
timeFrame: 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)
measure: Time to progression
timeFrame: 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)
measure: Largest change in target lesion size as judged by physicians
timeFrame: 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)
measure: Number of patients with treatment-emergent AEs
timeFrame: Approximately up to 27 month
measure: Change in laboratory data, including hemoglobin A1c (HbA1c) values
timeFrame: 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)
measure: Subsequent therapeutic options for treating iNHL post discontinuation of copanlisib
timeFrame: Approximately up to 27 month
Other outcomes:
Locations:
city: Multiple Locations
country: Taiwan
facility: Many Locations
Study officials:
References: