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OpenTrials
Completed

NCT Number: NCT03374137

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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Follicular Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inje University Busan Paik Hospital; Hematology-oncology, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

obinutuzumab

Biological

Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice.

Other names: Gazyva

Primary outcomes

  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 8 years)

  2. Percentage of Participants with Unexpected AE/ADR

    Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)

  3. Percentage of Participants with Expected ADR

    Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)

  4. Percentage of Participants with Non-serious ADR

    Time frame: 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)

    Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)

Secondary outcomes

  1. Overall Response Rate

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 15, 2017
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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