An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)

  • Leukemia
Trial Status:

Completed

This trial runs in
Countries
  • South Korea
Trial Identifier:

NCT03289182 ML39600

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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 is a prospective, multicenter, non-interventional study to test the safety and effectiveness of MabThera administered subcutaneously in participants with NHL or CLL. The length of study is expected to be 6 years.

      Hoffmann-La Roche Sponsor
      NCT03289182 , ML39600 Trial Identifier
      MabThera Treatments
      Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell Condition
      Official Title

      Post-Marketing Surveillance of MabThera Subcutaneous in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

      Eligibility Criteria

      All Gender
      ≥ 19 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Participants administered with MabThera subcutaneously within the approved indication in Korea
      • Participants previously untreated with MabThera subcutaneously

      Inclusion Criteria for NHL participants for MabThera subcutaneously 1400mg:

      • Relapsed or chemoresistant follicular lymphoma (FL) (B, C, and D type by international working formulation classification of B-cell NHL) participants
      • Previously untreated FL participants in combination with chemotherapy
      • Participants who are treated with maintenance therapy after the treatment of FL participants responding to induction therapy.
      • Cluster of differentiation 20-positive, diffuse large B-cell NHL participants in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone (8 cycles) chemotherapy

      Inclusion Criteria for CLL participants for MabThera subcutaneously 1600mg:

        - Previously untreated or relapsed/refractory CLL participants in combination with chemotherapy
      Exclusion Criteria
      • Pregnant or breastfeeding women
      • Participants who are out of locally approved indications, dosage, and administration including medication error
      • Contraindication in use by locally approved indications, dosage, and administration

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