Symbenda Post-Marketing Surveillance (PMS)

January 25, 2021 updated by: Eisai Korea Inc.

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Busan, Korea, Republic of
        • Eisai Trial Site #7
      • Busan, Korea, Republic of
        • Eisai Trial Site #8
      • Daegu, Korea, Republic of
        • Eisai Trial Site #6
      • Daejeon, Korea, Republic of
        • Eisai Trial Site #4
      • Daejeon, Korea, Republic of
        • Eisai Trial Site #5
      • Incheon, Korea, Republic of
        • Eisai Trial Site #9
      • Seoul, Korea, Republic of
        • Eisai Trial Site #1
      • Seoul, Korea, Republic of
        • Eisai Trial Site #2
      • Seoul, Korea, Republic of
        • Eisai Trial Site #3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study.

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:

  1. Patients with approved indication for Symbenda in Korea
  2. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Symbenda
Subjects who are prescribed with Symbenda per approved prescribing information of Symbenda will be enrolled in the study.

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
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.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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
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
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.
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
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.
After 2nd cycle (each cycle = 28 days) up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2018

Primary Completion (Actual)

March 20, 2020

Study Completion (Actual)

March 20, 2020

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

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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