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

  • Chronic Lymphocytic Leukemia
Trial Status:

Recruiting

This trial runs in
Countries
  • South Korea
Trial Identifier:

NCT03374137 ML30074

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      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.

      Hoffmann-La Roche Sponsor
      NCT03374137 , ML30074 Trial Identifier
      obinutuzumab Treatments
      Chronic Lymphocytic Leukemia, Follicular Lymphoma Condition
      Official Title

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

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      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

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