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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03374137
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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
Chronic Lymphocytic Leukemia Follicular Lymphoma Biological: obinutuzumab

Study Design
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Study Type : Observational
Estimated 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 : March 9, 2018
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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 Name: Gazyva


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Serious Adverse Event (AE)/Adverse Drug Reaction (ADR) [ Time Frame: from baseline until the end of the participant's observation period (up to approximately 6 years) ]
  2. Percentage of Participants with Unexpected AE/ADR [ Time Frame: from baseline until end of the participant's observation period (up to approximately 6 years) ]
  3. Percentage of Participants with Expected ADR [ Time Frame: from baseline until end of the participant's observation period (up to approximately 6 years) ]
  4. Percentage of Participants with Non-serious ADR [ Time Frame: from baseline until end of the participant's observation period (up to approximately 6 years) ]
  5. Percentage of Participants with AEs of Special Interest (AESIs) [ Time Frame: from baseline until end of the participant's observation period (up to approximately 6 years) ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: from baseline until end of the participant's observation period (up to approximately 6 years) ]
    According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for CLL or Cheson 2014 criteria for FL

  2. Stable Disease Rate [ Time Frame: from baseline until end of the participant's observation period (up to approximately 6 years) ]
    According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL

  3. Progressive Disease Rate [ Time Frame: from baseline until end of the participant's observation period (up to approximately 6 years) ]
    According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374137


Contacts
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Contact: Reference Study ID Number: ML30074 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Korea, Republic of
Inje University Busan Paik Hospital; Hematology-oncology Recruiting
Busan, Korea, Republic of, 47392
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 49241
St. Vincent's Hospital Active, not recruiting
Gyeonggi-do, Korea, Republic of, 16247
Hallym University Sacred Heart Hospital; Department of Hematology Recruiting
Gyeonggi-do, Korea, Republic of, 431-070
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 02447
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Seoul St Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
ChungAng University Hospital Recruiting
Seoul, Korea, Republic of, 06973
Borame Medical Center Recruiting
Seoul, Korea, Republic of, 07061
Yeouido St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 07345
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
The Catholic University of Korea Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-701
Yonsei University Wonju Severance Christian Hospital Recruiting
Wonju-Si, Korea, Republic of, 220-701
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03374137    
Other Study ID Numbers: ML30074
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: March 2022

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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:
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Lymphoma
Leukemia
Lymphoma, Follicular
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Obinutuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents