Relapsed or Refractory Indolent Non-Hodgkin LymphomaNCT05217914
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
An observational study of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma, run by Bayer at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Indolent Non-Hodgkin Lymphoma
- What is being tested?
- Copanlisib (BAY80-6946)
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2022to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Copanlisib in Indolent Non-Hodgkin Lymphoma Patients: A Real-world Taiwan Observation Multicenter Study
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.
Read more
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.
- Being tested
- Copanlisib (BAY80-6946)
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copanlisib (BAY80-6946)Drug
Copanlisib for treatment of relapse/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Copanlisib (BAY80-6946) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately up to 27 month
Secondary outcomes (11)
Ann Arbor stage of the first diagnosis of iNHL
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Approximately up to 27 month
Change in laboratory data, including hemoglobin A1c (HbA1c) values
Measured: 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
Measured: Approximately up to 27 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Jul 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Indolent Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217914
- Sponsor's protocol ID
- 21960
- Status last verified
- Oct 2024
- First submitted
- 20 Jan 2022
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copanlisib in Indolent Non-Hodgkin Lymphoma Patients: A Real-world Taiwan Observation Multicenter Study
- ClinicalTrials.gov ID
- NCT05217914
- Acronym / sponsor ID
- 21960
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| r/r iNHL Patients: Copanlisib treatment | – | Drug: Copanlisib (BAY80-6946)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copanlisib (BAY80-6946)Copanlisib for treatment of relapse/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL) | Drug | r/r iNHL Patients: Copanlisib treatment |
Primary outcome
Dose regimes
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
11 secondary outcomes
Ann Arbor stage of the first diagnosis of iNHL
Time frame: Approximately up to 27 month
Previous treatment regimens
Time frame: Approximately up to 27 month
Type of treatment response
Time 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)
Time 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
Time 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
Time 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
Time 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
Time 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
Time frame: Approximately up to 27 month
Change in laboratory data, including hemoglobin A1c (HbA1c) values
Time 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
Time frame: Approximately up to 27 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma, run by Bayer at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose regimes (time frame: Approximately up to 27 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.