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

NCT ID: NCT05217914

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-08-31

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.

Conditions

Relapsed or Refractory Indolent Non-Hodgkin Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Copanlisib (BAY80-6946)

Intervention Type: DRUG

Copanlisib for treatment of relapse/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL)

Interventions

Copanlisib (BAY80-6946)

Copanlisib for treatment of relapse/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Many Locations

Multiple Locations, , Taiwan

Countries

Taiwan

Related Links

https://clinicaltrials.bayer.com

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Other Identifiers

21960

Identifier Type: -

Identifier Source: org_study_id