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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Response rate using the International Working Group criteria | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Indication according to the Summary of Product Characteristics (SPC) for MabThera SC formulation:
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 Criteria:
Contraindications according to SPC for MabThera SC formulation:
Patient included in clinical trials with experimental pharmaceuticals
Pregnancy
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Patients within label indication for MabThera SC and subject for induction therapy with MabThera SC; patients object for maintenance therapy are excluded
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskilstuna | 63188 | Sweden | ||||
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Incidence of serious adverse events | Through to end of study, up to approximately 1 year |
| Halmstad |
| 301 85 |
| Sweden |
| Helsingborg | 25187 | Sweden |
| Linköping | 581 85 | Sweden |
| Luleå | S-971 80 | Sweden |
| Örebro | 701 85 | Sweden |
| Visby | 62184 | Sweden |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |