check_circleStudy Completed

Relapsed or refractory indolent non-Hodgkin lymphoma

Bayer Identifier:

21960

ClinicalTrials.gov Identifier:

NCT05217914

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
6
Trial Dates
July 2022 - August 2024
Phase
Phase 4
Could I Receive a placebo
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
many locationsmany locations, Taiwan

Primary Outcome

  • Dose regimes
    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.
    date_rangeTime Frame:
    Approximately up to 27 month
  • Treatment duration
    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.
    date_rangeTime Frame:
    Approximately up to 27 month
  • Number of treatment cycles
    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.
    date_rangeTime Frame:
    Approximately up to 27 month
  • Reasons of discontinuations
    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.
    date_rangeTime Frame:
    Approximately up to 27 month

Secondary Outcome

  • Ann Arbor stage of the first diagnosis of iNHL
    date_rangeTime Frame:
    Approximately up to 27 month
  • Previous treatment regimens
    Previous treatment regimens from the first diagnosis of iNHL until the initiation of copanlisib, including the duration from the first diagnosis of iNHL to the first dose of copanlisib, the POD (i.e., POD > 24 or POD ≤ 24) after the first line anticancer therapy for iNHL, and the duration from the most recent PD to the first dose of copanlisib.
    date_rangeTime Frame:
    Approximately up to 27 month
  • Type of treatment response
    Type of treatment response [complete response (CR)/ complete response undefined (CRu)/partial response (PR)] based on the physicians’ assessment according to local standard.
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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)
  • Progression status after the first dose of copanlisib
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Approximately up to 27 month
  • Change in laboratory data, including hemoglobin A1c (HbA1c) values
    date_rangeTime Frame:
    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)
  • Subsequent therapeutic options for treating iNHL post discontinuation of copanlisib
    date_rangeTime Frame:
    Approximately up to 27 month

Trial design

Copanlisib in Indolent Non-Hodgkin Lymphoma Patients: A Real-world Taiwan Observation Multicenter Study
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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