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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

NCT05217914 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2024-10-24

No results posted yet for this study

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

Interventions

DRUG

Copanlisib (BAY80-6946)

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

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Taiwan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05217914 on ClinicalTrials.gov