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

Completed

• Conditions: Chronic Lymphocytic Leukemia; Follicular Lymphoma

• Registration Number: NCT03374137
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-15
• Study Start: 2018-03-09
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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 AEs of Special Interest (AESIs)	from baseline until end of the participant's observation period (up to approximately 8 years)

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (17)

Inje University Busan Paik Hospital; Hematology-oncology; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

St. Vincent's Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Hallym University Sacred Heart Hospital; Department of Hematology; 🇰🇷 Gyeonggi-do, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Catholic Univ. of Incheon St.Mary's Hospital; Hemato-oncology; 🇰🇷 Incheon, Korea, Republic of

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul St Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Scroll for more (7 remaining)