Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This observational study aims to assess the therapeutic responsiveness of MabThera SC in patients with malignant lymphomas under everyday clinical practice conditions. Patients with previously untreated CD-20 positive follicular non-Hodgkin's lymphoma (NHL) or previously untreated CD-20 positive diffuse large B-cell lymphoma (DLBCL) who are planned for therapy with MabThera SC according to the assessment of the physician will be prospectively enrolled for observation. No study specific measures are required; treatment and documentation will be performed according to usual clinical practice.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follicular NHL Cohort | |||
| DLBCL Cohort |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in both indications (DLBCL and follicular NHL) who have reached a complete remission (CR), including unconfirmed complete remission (CRu) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Total response rate | Up to 2.5 years | |
| Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy | 2 years | |
| Safety profile: incidence, nature, severity, and outcomes of all adverse events and pregnancies (composite outcome measure) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
All contraindications, interactions and incompatibilities for therapy with MabThera SC
Not provided
Not provided
Not provided
CD-20 positive, diffuse large cell B-cell non-Hodgkin lymphoma (DLBCL) and CD-20 positive follicular non-Hodgkin lymphoma (NHL)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Essen; Klinik für Hämatologie | Essen | 45122 | Germany |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 2.5 years |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |