Status:
COMPLETED
Observational Study to Monitor Safety and Effectiveness of Obinutuzumab in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Chronic Lymphocytic Leukemia
Follicular Lymphoma
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- Administered obinutuzumab under the approved indications in Korea at investigator's discretion
- Previously untreated with obinutuzumab
Exclusion
- Out-of locally approved indications, dosage, and administration
- Pregnant women, breastfeeding women
- Hepatic disease
- Participate in other clinical trials
Key Trial Info
Start Date :
March 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03374137
Start Date
March 9 2018
End Date
November 10 2022
Last Update
January 12 2023
Active Locations (17)
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1
Inje University Busan Paik Hospital; Hematology-oncology
Busan, South Korea, 47392
2
Pusan National University Hospital
Busan, South Korea, 602-739
3
St. Vincent's Hospital
Gyeonggi-do, South Korea, 16247
4
Hallym University Sacred Heart Hospital; Department of Hematology
Gyeonggi-do, South Korea, 431-070