- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02434484
Symbenda Post-Marketing Surveillance (PMS)
Post-Marketing Surveillance of Symbenda Injection (Bendamustine Hydrochloride) in Korean Patients
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Busan, Korea, Republic of
- Eisai Trial Site #7
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Busan, Korea, Republic of
- Eisai Trial Site #8
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Daegu, Korea, Republic of
- Eisai Trial Site #6
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Daejeon, Korea, Republic of
- Eisai Trial Site #4
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Daejeon, Korea, Republic of
- Eisai Trial Site #5
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Incheon, Korea, Republic of
- Eisai Trial Site #9
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Seoul, Korea, Republic of
- Eisai Trial Site #1
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Seoul, Korea, Republic of
- Eisai Trial Site #2
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Seoul, Korea, Republic of
- Eisai Trial Site #3
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study.
This study will be conducted as complete surveillance method; subjects who meet the inclusion/exclusion criteria and administrate Symbenda for the first time after conclusion of agreement will be enrolled.
Inclusion Criteria:
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.
Exclusion Criteria:
Investigators will refer to approved indications and contraindications regarding exclusion criteria.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Symbenda
Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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. |
After 2nd cycle (each cycle = 28 days) up to 1.5 months
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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
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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.
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After 2nd cycle (each cycle = 28 days) up to 2 months
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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
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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.
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After 2nd cycle (each cycle = 28 days) up to 2 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Leukemia
- Lymphoma
- Multiple Myeloma
- Lymphoma, Non-Hodgkin
- Leukemia, Lymphoid
Other Study ID Numbers
- B0501-M065-501
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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