Lymphoma, Non-HodgkinNCT02434484
Symbenda Post-Marketing Surveillance (PMS)
An observational study of Lymphoma, Non-Hodgkin and Lymphocytic Leukemia, run by Eisai Korea Inc. at 9 sites in South Korea.
Trial summary
This is a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The main objective is to obtain safety information related to Symbenda treatment from clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Lymphocytic Leukemia, Multiple Myeloma
- How many people
- 84 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 4 Jul 2018to 20 Mar 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study.
Who may be able to join
- Patients who meet the following criteria will be eligible for inclusion in the study:
- Patients with approved indication for Symbenda in Korea
- Patients who have verbal or written consent for use of personal and medical information for the study purpose Investigators will refer to approved indications and contraindications regarding inclusion criteria.
Who cannot join
- Investigators will refer to approved indications and contraindications regarding exclusion criteria.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Eisai Trial Site #7
Busan
Eisai Trial Site #8
Busan
Eisai Trial Site #6
Daegu
Eisai Trial Site #4
Daejeon
Eisai Trial Site #5
Daejeon
Eisai Trial Site #9
Incheon
Eisai Trial Site #1
Seoul
Eisai Trial Site #2
Seoul
Eisai Trial Site #3
Seoul
About this study
Official title: Post-Marketing Surveillance of Symbenda Injection (Bendamustine Hydrochloride) in Korean Patients
This is a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The main objective is to obtain safety information related to Symbenda treatment from clinical practice.
- Keywords
- Symbenda, Non-Hodgkin's lymphomas, Chronic lymphocytic leukemia, Multiple myeloma, Bendamustine Hydrochloride
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphoid, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Symbenda | Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Symbenda as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
Measured: Up to 6 months
Secondary outcomes (3)
Non-Hodgkin's lymphomas response rate per Standardize Response Criteria for Non-Hodgkin's lymphomas to assess the tumor response
Non-Hodgkin's lymphoma(NHL) is a cancer that starts in cells called lymphocytes, which are part of the body's immune system. Lymphocytes are in the lymph nodes and other lymphoid tissues (such as the spleen and bone marrow). Non-hodgkin's lymphoma is classified with two broad categories, such as high-grade or aggressive and low-grade or indolent.
Response criteria for non-Hodgkin's lymphomas will be used to assess tumor response.
Measured: After 2nd cycle (each cycle = 28 days) up to 1.5 months
Chronic lymphocytic leukemia response rate per National Cancer Institute-Sponsored Working Group (NCISWG) criteria to assess the tumor response
Chronic lymphocytic leukemia is a type of cancer that starts from cells that become lymphocytes in the bone marrow. The cancer (leukemia) cells start in the bone marrow but then migrate into the blood. NCISWG criteria will be used to assess tumor response.
Measured: After 2nd cycle (each cycle = 28 days) up to 2 months
Multiple myeloma response rate per International Myeloma Working Group (IMWG) uniform response criteria to assess the tumor response
Multiple myeloma is a cancer formed by malignant plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system. IMWG Uniform Response Criteria will be used to assess tumor response.
Measured: After 2nd cycle (each cycle = 28 days) up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study start4 Jul 2018
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434484
- Sponsor's protocol ID
- B0501-M065-501
- Status last verified
- Jan 2021
- First submitted
- 28 Apr 2015
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Symbenda Injection (Bendamustine Hydrochloride) in Korean Patients
- ClinicalTrials.gov ID
- NCT02434484
- Acronym / sponsor ID
- B0501-M065-501
- Keywords
- Symbenda, Non-Hodgkin's lymphomas, Chronic lymphocytic leukemia, Multiple myeloma, Bendamustine Hydrochloride
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 5 May 2015 (estimated)
- 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 a PMS of Symbenda Injection (bendamustine hydrochloride) in Korean Patients. The main objective is to obtain safety information related to Symbenda treatment from clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symbenda | – | –Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study.
Key inclusion criteria (3 listed)
- Patients with approved indication for Symbenda in Korea
- Patients who have verbal or written consent for use of personal and medical information for the study purpose Investigators will refer to approved indications and contraindications regarding inclusion criteria.
Key exclusion criteria (1 listed)
- Investigators will refer to approved indications and contraindications regarding exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of Symbenda as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
Time frame: Up to 6 months
An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
3 secondary outcomes
Non-Hodgkin's lymphomas response rate per Standardize Response Criteria for Non-Hodgkin's lymphomas to assess the tumor response
Time frame: After 2nd cycle (each cycle = 28 days) up to 1.5 months
Chronic lymphocytic leukemia response rate per National Cancer Institute-Sponsored Working Group (NCISWG) criteria to assess the tumor response
Time frame: After 2nd cycle (each cycle = 28 days) up to 2 months
Multiple myeloma response rate per International Myeloma Working Group (IMWG) uniform response criteria to assess the tumor response
Time frame: After 2nd cycle (each cycle = 28 days) up to 2 months
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 26 Jan 2021.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Non-Hodgkin and Lymphocytic Leukemia, run by Eisai Korea Inc. at 9 sites in South Korea.
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 3 inclusion and 1 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 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. 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?
Safety of Symbenda as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions (time frame: Up to 6 months). 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 26 Jan 2021.