Effectiveness, Safety & Nurse Management Study of MabThera SC in Patients With Non-Hodgkin's Lymphoma: Real-Life Setting
Conditions
Non-Hodgkin's Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Eskilstuna, Sweden
Status: Recruiting
Halmstad, Sweden
Status: Recruiting
Helsingborg, Sweden
Status: Recruiting
Linkoeping, Sweden
Status: Recruiting
Luleå, Sweden
Status: Recruiting
Visby, Sweden
Status: Recruiting
Örebro, Sweden
Status: Recruiting
Start Date
August 2014
Completion Date
December 2015
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page