Clinical trial NCT03374137: Observational Study to Monitor Safety and Effectiveness of Obinutuzumab in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia
Official title: Post-Marketing Surveillance of Gazyva in Treatment of Patients With Gazyva in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Follicular Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants, who are going to receive obinutuzumab for one or more administrations according to medical opinions of the investigator in charge of surveillance, will be registered for this surveillance and treated with obinutuzumab under the approval conditions of the product in Korea

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with Serious Adverse Event (AE)/Adverse Drug Reaction (ADR)
timeFrame: from baseline until the end of the participant's observation period (up to approximately 8 years)
measure: Percentage of Participants with Unexpected AE/ADR
timeFrame: from baseline until end of the participant's observation period (up to approximately 8 years)
measure: Percentage of Participants with Expected ADR
timeFrame: from baseline until end of the participant's observation period (up to approximately 8 years)
measure: Percentage of Participants with Non-serious ADR
timeFrame: from baseline until end of the participant's observation period (up to approximately 8 years)
measure: Percentage of Participants with AEs of Special Interest (AESIs)
timeFrame: from baseline until end of the participant's observation period (up to approximately 8 years)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: from baseline until end of the participant's observation period (up to approximately 8 years)
measure: Stable Disease Rate
timeFrame: from baseline until end of the participant's observation period (up to approximately 8 years)
measure: Progressive Disease Rate
timeFrame: from baseline until end of the participant's observation period (up to approximately 8 years)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital; Hematology-oncology
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: St. Vincent's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital; Department of Hematology
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Catholic Univ. of Incheon St.Mary's Hospital; Hemato-oncology
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: ChungAng University Hospital
city: Seoul
country: Korea, Republic of
facility: Borame Medical Center
city: Seoul
country: Korea, Republic of
facility: Yeouido St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Wonju-Si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: