Status:
COMPLETED
Effectiveness, Safety & Nurse Management Study of MabThera SC in Patients With Non-Hodgkin's Lymphoma: Real-Life Setting
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
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 l...
Eligibility Criteria
Inclusion
- 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
- At least 4 treatment cycles with MabThera is planned
- Patients \>/= 18 years at inclusion
- Patients written informed consent
- Treatment decision to prescribe MabThera SC has been taken by the physician prior to recruitment into the study
Exclusion
- 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
- Patient included in clinical trials with experimental pharmaceuticals
- Pregnancy
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02199288
Start Date
August 1 2014
End Date
July 1 2016
Last Update
November 2 2016
Active Locations (7)
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1
Eskilstuna, Sweden, 63188
2
Halmstad, Sweden, 301 85
3
Helsingborg, Sweden, 25187
4
Linköping, Sweden, 581 85