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

Roche

Status: Completed

Conditions: Non-Hodgkin's Lymphoma

Study type: Observational

Funder types: Industry

Identifiers

NCT02199288

ML29314

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

54 participants in 1 patient group

Cohort