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

N/ACompletedNCT02199288

Hoffmann-La Roche54 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non-Hodgkin's Lymphoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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

Locations (7)

Unnamed facility

Eskilstuna, Sweden

Unnamed facility

Halmstad, Sweden

Unnamed facility

Helsingborg, Sweden

Unnamed facility

Linköping, Sweden

Unnamed facility

Outcomes

Primary Outcomes

Response rate using the International Working Group criteria

Time frame: 8 months

Secondary Outcomes

Incidence of adverse events

Time frame: 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

Time frame: Through to end of study, up to approximately 1 year

Incidence of serious adverse events

Time frame: Through to end of study, up to approximately 1 year

Data from ClinicalTrials.gov

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