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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Post-Marketing Surveillance of Gazyva in Treatment of Patients With Gazyva in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374137
• Other study ID #: ML30074
• Status: Completed
• Start date: March 9, 2018
• Est. completion date: November 10, 2022

Study information

• Verified date: January 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 10, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Follicular Lymphoma
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Follicular

Intervention

Biological:
• obinutuzumab
Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice.

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital; Hematology-oncology	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Hallym University Sacred Heart Hospital; Department of Hematology	Gyeonggi-do
Korea, Republic of	St. Vincent's Hospital	Gyeonggi-do
Korea, Republic of	Catholic Univ. of Incheon St.Mary's Hospital; Hemato-oncology	Incheon
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Borame Medical Center	Seoul
Korea, Republic of	ChungAng University Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju-Si

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Percentage of Participants with Unexpected AE/ADR		from baseline until end of the participant's observation period (up to approximately 8 years)
Primary	Percentage of Participants with Expected ADR		from baseline until end of the participant's observation period (up to approximately 8 years)
Primary	Percentage of Participants with Non-serious ADR		from baseline until end of the participant's observation period (up to approximately 8 years)
Primary	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	Overall Response Rate	According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for CLL or Cheson 2014 criteria for FL	from baseline until end of the participant's observation period (up to approximately 8 years)
Secondary	Stable Disease Rate	According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL	from baseline until end of the participant's observation period (up to approximately 8 years)
Secondary	Progressive Disease Rate	According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL	from baseline until end of the participant's observation period (up to approximately 8 years)