Observational Study to Monitor Safety and Effectiveness of Obinutuzumab in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia
Post-Marketing Surveillance of Gazyva in Treatment of Patients With Gazyva in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia Patients
1 other identifier
observational
55
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2018
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2017
CompletedFirst Posted
Study publicly available on registry
December 15, 2017
CompletedStudy Start
First participant enrolled
March 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2022
CompletedJanuary 12, 2023
January 1, 2023
4.7 years
December 12, 2017
January 11, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Percentage of Participants with Serious Adverse Event (AE)/Adverse Drug Reaction (ADR)
from baseline until the end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Unexpected AE/ADR
from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Expected ADR
from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Non-serious ADR
from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with AEs of Special Interest (AESIs)
from baseline until end of the participant's observation period (up to approximately 8 years)
Secondary Outcomes (3)
Overall Response Rate
from baseline until end of the participant's observation period (up to approximately 8 years)
Stable Disease Rate
from baseline until end of the participant's observation period (up to approximately 8 years)
Progressive Disease Rate
from baseline until end of the participant's observation period (up to approximately 8 years)
Study Arms (1)
obinutuzumab
Participants with follicular lymphoma or previously untreated chronic lymphocytic leukemia will be treated with obinutuzumab.
Interventions
Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice.
Eligibility Criteria
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
You may qualify if:
- Administered obinutuzumab under the approved indications in Korea at investigator's discretion
- Previously untreated with obinutuzumab
You may not qualify if:
- Out-of locally approved indications, dosage, and administration
- Pregnant women, breastfeeding women
- Hepatic disease
- Participate in other clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Inje University Busan Paik Hospital; Hematology-oncology
Busan, 47392, South Korea
Pusan National University Hospital
Busan, 602-739, South Korea
St. Vincent's Hospital
Gyeonggi-do, 16247, South Korea
Hallym University Sacred Heart Hospital; Department of Hematology
Gyeonggi-do, 431-070, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Catholic Univ. of Incheon St.Mary's Hospital; Hemato-oncology
Incheon, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Seoul St Mary's Hospital
Seoul, 06591, South Korea
ChungAng University Hospital
Seoul, 06973, South Korea
Borame Medical Center
Seoul, 07061, South Korea
Yeouido St. Mary's Hospital
Seoul, 07345, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 6591, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220-701, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2017
First Posted
December 15, 2017
Study Start
March 9, 2018
Primary Completion
November 10, 2022
Study Completion
November 10, 2022
Last Updated
January 12, 2023
Record last verified: 2023-01