Lymphoma, B-Cell, Lymphoma, Follicular Clinical Trial
| NCT number | NCT02240316 |
| Other study ID # | ML28886 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 8, 2014 |
| Est. completion date | July 22, 2019 |
| Verified date | October 2020 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 688 |
| Est. completion date | July 22, 2019 |
| Est. primary completion date | July 22, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Women and men aged >=18 years - Previously untreated CD-20 positive follicular NHL - Previously untreated CD-20 positive DLBCL - Planned therapy with MabThera SC according to the assessment of the physician (before the start and independent from this study) - Suitability for the therapy with MabThera SC Exclusion Criteria: All contraindications, interactions and incompatibilities for therapy with MabThera SC |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Universitätsklinikum Essen; Klinik für Hämatologie | Essen |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Secondary | Total response rate | Up to 2.5 years | ||
| Secondary | Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy | 2 years | ||
| Secondary | Safety profile: incidence, nature, severity, and outcomes of all adverse events and pregnancies (composite outcome measure) | Up to 2.5 years |