Effectiveness, Safety & Nurse Management Study of MabThera SC in Patients With Non-Hodgkin's Lymphoma: Real-Life Setting

Completed

• Conditions: Non-Hodgkin's Lymphoma

• Registration Number: NCT02199288
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This prospective, open-label, multicenter, observational study will investigate the effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-24
• Study Start: 2014-08
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Indication according to the Summary of Product Characteristics (SPC) for MabThera SC formulation:

   • As treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy
   • As treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with chemotherapy

2. At least 4 treatment cycles with MabThera is planned

3. Patients >/= 18 years at inclusion

4. Patients written informed consent

5. Treatment decision to prescribe MabThera SC has been taken by the physician prior to recruitment into the study

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Exclusion Criteria

1. Contraindications according to SPC for MabThera SC formulation:

   • Hypersensitivity for the active substance or murine antibodies, hyaluronidase or any other excipients
   • Active and severe infections
   • Patients with severe immunsuppression

2. Patient included in clinical trials with experimental pharmaceuticals

3. Pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate using the International Working Group criteria	8 months

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Through to end of study, up to approximately 1 year
Incidence of administration related reactions during induction therapy in patients who have previously received at least one dose of MabThera IV	Through to end of study, up to approximately 1 year
Incidence of serious adverse events	Through to end of study, up to approximately 1 year