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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03374137
• Collaborator: (none)
• Enrollment: 55
• Locations: 17
• Anticipated Duration (Months): 57.8
• Patients Per Site: 3.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia; Follicular Lymphoma	Biological: obinutuzumab

Study Design

• Study Type: Observational
• Anticipated Enrollment: 55 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-Marketing Surveillance of Gazyva in Treatment of Patients With Gazyva in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia Patients
• Actual Study Start Date: Mar 9, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
obinutuzumab Participants with follicular lymphoma or previously untreated chronic lymphocytic leukemia will be treated with obinutuzumab.	Biological: obinutuzumab; Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice.; Other Names: Gazyva

Outcome Measures

Primary Outcome Measures

1. 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)]

2. Percentage of Participants with Unexpected AE/ADR [from baseline until end of the participant's observation period (up to approximately 8 years)]

3. Percentage of Participants with Expected ADR [from baseline until end of the participant's observation period (up to approximately 8 years)]

4. Percentage of Participants with Non-serious ADR [from baseline until end of the participant's observation period (up to approximately 8 years)]

5. 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

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje University Busan Paik Hospital; Hematology-oncology	Busan		Korea, Republic of	47392
2	Pusan National University Hospital	Busan		Korea, Republic of	49241
3	St. Vincent's Hospital	Gyeonggi-do		Korea, Republic of	16247
4	Hallym University Sacred Heart Hospital; Department of Hematology	Gyeonggi-do		Korea, Republic of	431-070
5	Gachon University Gil Medical Center	Incheon		Korea, Republic of	21565
6	Catholic Univ. of Incheon St.Mary's Hospital; Hemato-oncology	Incheon		Korea, Republic of
7	Kyung Hee University Hospital	Seoul		Korea, Republic of	02447
8	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
9	Seoul National University Hospital	Seoul		Korea, Republic of	03080
10	Samsung Medical Center	Seoul		Korea, Republic of	06351
11	Seoul St Mary's Hospital	Seoul		Korea, Republic of	06591
12	ChungAng University Hospital	Seoul		Korea, Republic of	06973
13	Borame Medical Center	Seoul		Korea, Republic of	07061
14	Yeouido St. Mary's Hospital	Seoul		Korea, Republic of	07345
15	Korea University Guro Hospital	Seoul		Korea, Republic of	08308
16	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul		Korea, Republic of	137-701
17	Yonsei University Wonju Severance Christian Hospital	Wonju-Si		Korea, Republic of	220-701

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03374137
• Other Study ID Numbers: ML30074
• First Posted: Dec 15, 2017
• Last Update Posted: Jul 5, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Lymphoma; Leukemia; Lymphoma, Follicular; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Obinutuzumab

Study Results

No Results Posted as of Jul 5, 2022