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

Roche

Status: Completed

Conditions: Follicular Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Biological: obinutuzumab

Study type: Observational

Funder types: Industry

Identifiers

NCT03374137

ML30074

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 1 patient group

obinutuzumab

Description:

Participants with follicular lymphoma or previously untreated chronic lymphocytic leukemia will be treated with obinutuzumab.

Treatment:

Biological: obinutuzumab