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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-09

Study Completion Date

2022-11-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia Follicular Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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obinutuzumab

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

obinutuzumab

Intervention Type BIOLOGICAL

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

Interventions

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obinutuzumab

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Gazyva

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No