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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03374137

Enrollment

Registered

2017-12-15

Start date

2018-03-09

Completion date

2022-11-10

Last updated

2023-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, Follicular Lymphoma

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.

Interventions

BIOLOGICALobinutuzumab

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with AEs of Special Interest (AESIs)	from baseline until 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 Serious Adverse Event (AE)/Adverse Drug Reaction (ADR)	from baseline until the end of the participant's observation period (up to approximately 8 years)

Secondary

Measure	Time frame	Description
Stable Disease Rate	from baseline until end of the participant's observation period (up to approximately 8 years)	According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL
Progressive Disease Rate	from baseline until end of the participant's observation period (up to approximately 8 years)	According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL
Overall Response Rate	from baseline until end of the participant's observation period (up to approximately 8 years)	According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for CLL or Cheson 2014 criteria for FL

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026