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

Completed

• Conditions: Lymphoma, B-Cell, Lymphoma, Follicular

• Registration Number: NCT02240316
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-08
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Primary Completion: 2019-07-22
• Study Completion: 2019-07-22
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 688

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

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Exclusion Criteria

All contraindications, interactions and incompatibilities for therapy with MabThera SC

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients in both indications (DLBCL and follicular NHL) who have reached a complete remission (CR), including unconfirmed complete remission (CRu)	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy	2 years
Safety profile: incidence, nature, severity, and outcomes of all adverse events and pregnancies (composite outcome measure)	Up to 2.5 years
Total response rate	Up to 2.5 years

Trial Locations

Locations (1)

Universitätsklinikum Essen; Klinik für Hämatologie; 🇩🇪 Essen, Germany