Observational Study to Monitor Safety and Effectiveness of Obinutuzumab in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia

January 11, 2023 updated by: Hoffmann-La Roche

Post-Marketing Surveillance of Gazyva in Treatment of Patients With Gazyva in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia Patients

This study aims to collect clinical data, mainly focused on safety, in the local target population as per the requirement of Korea Ministry of Food and Drug Safety for market authorization. The study population comprises patients with approved local indications chronic lymphocytic leukemia (CLL) and/or follicular lymphoma (FL) in routine clinical practice after launch.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

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

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 47392
        • Inje University Busan Paik Hospital; Hematology-oncology
      • Gyeonggi-do, Korea, Republic of, 16247
        • St. Vincent's Hospital
      • Gyeonggi-do, Korea, Republic of, 431-070
        • Hallym University Sacred Heart Hospital; Department of Hematology
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of
        • Catholic Univ. of Incheon St.Mary's Hospital; Hemato-oncology
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 02447
        • Kyung Hee University Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 06591
        • Seoul St Mary's Hospital
      • Seoul, Korea, Republic of, 07061
        • Borame Medical Center
      • Seoul, Korea, Republic of, 06973
        • Chungang University Hospital
      • Seoul, Korea, Republic of, 07345
        • Yeouido St. Mary's Hospital
      • Seoul, Korea, Republic of, 6591
        • The Catholic University of Korea Seoul St. Mary's Hospital
      • Wonju-Si, Korea, Republic of, 220-701
        • Yonsei University Wonju Severance Christian Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants, who are going to receive obinutuzumab for one or more administrations according to medical opinions of the investigator in charge of surveillance, will be registered for this surveillance and treated with obinutuzumab under the approval conditions of the product in Korea

Description

Inclusion Criteria:

  • Administered obinutuzumab under the approved indications in Korea at investigator's discretion
  • Previously untreated with obinutuzumab

Exclusion Criteria:

  • Out-of locally approved indications, dosage, and administration
  • Pregnant women, breastfeeding women
  • Hepatic disease
  • Participate in other clinical trials

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
obinutuzumab
Participants with follicular lymphoma or previously untreated chronic lymphocytic leukemia will be treated with obinutuzumab.
Biological: obinutuzumab
Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice.
Other Names:
  • Gazyva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Serious Adverse Event (AE)/Adverse Drug Reaction (ADR)
Time Frame: from baseline until the end of the participant's observation period (up to approximately 8 years)
from baseline until the end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Unexpected AE/ADR
Time Frame: from baseline until end of the participant's observation period (up to approximately 8 years)
from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Expected ADR
Time Frame: from baseline until end of the participant's observation period (up to approximately 8 years)
from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Non-serious ADR
Time Frame: from baseline until end of the participant's observation period (up to approximately 8 years)
from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with AEs of Special Interest (AESIs)
Time Frame: from baseline until end of the participant's observation period (up to approximately 8 years)
from baseline until end of the participant's observation period (up to approximately 8 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: from baseline until end of the participant's observation period (up to approximately 8 years)
According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for CLL or Cheson 2014 criteria for FL
from baseline until end of the participant's observation period (up to approximately 8 years)
Stable Disease Rate
Time Frame: from baseline until end of the participant's observation period (up to approximately 8 years)
According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL
from baseline until end of the participant's observation period (up to approximately 8 years)
Progressive Disease Rate
Time Frame: from baseline until end of the participant's observation period (up to approximately 8 years)
According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL
from baseline until end of the participant's observation period (up to approximately 8 years)

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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)

March 9, 2018

Primary Completion (Actual)

November 10, 2022

Study Completion (Actual)

November 10, 2022

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 15, 2017

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML30074

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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