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

Hoffmann-La Roche55 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Lymphocytic Leukemia Follicular Lymphoma

Interventions

obinutuzumabBIOLOGICAL

Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Inje University Busan Paik Hospital; Hematology-oncology

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Outcomes

Primary Outcomes

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)

Percentage of Participants with Unexpected AE/ADR