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Completed

NCT Number: NCT02240316

An Observational Study of Patients With Malignant Lymphomas Treated With MabThera® SC in Everyday Clinical Practice

This observational study aims to assess the therapeutic responsiveness of MabThera SC in patients with malignant lymphomas under everyday clinical practice conditions. Patients with previously untreated CD-20 positive follicular non-Hodgkin's lymphoma (NHL) or previously untreated CD-20 positive diffuse large B-cell lymphoma (DLBCL) who are planned for therapy with MabThera SC according to the assessment of the physician will be prospectively enrolled for observation. No study specific measures are required; treatment and documentation will be performed according to usual clinical practice.

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Key information

Conditions

Lymphoma, B-Cell, Lymphoma, Follicular Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Essen; Klinik für Hämatologie

Essen, 45122, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women and men aged >=18 years
  • Previously untreated CD-20 positive follicular NHL
  • Previously untreated CD-20 positive DLBCL
  • Planned therapy with MabThera SC according to the assessment of the physician (before the start and independent from this study)
  • Suitability for the therapy with MabThera SC

Exclusion criteria

All contraindications, interactions and incompatibilities for therapy with MabThera SC

Treatment and study plan

Primary outcomes

  1. Proportion of patients in both indications (DLBCL and follicular NHL) who have reached a complete remission (CR), including unconfirmed complete remission (CRu)

    Time frame: Up to 2 years

Secondary outcomes

  1. Total response rate

    Time frame: Up to 2.5 years

  2. Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy

    Time frame: 2 years

  3. Safety profile: incidence, nature, severity, and outcomes of all adverse events and pregnancies (composite outcome measure)

    Time frame: Up to 2.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 15, 2014
Registry last updated
Oct 30, 2020

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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