Lymphoma, B-Cell, Lymphoma, Follicular
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile: incidence, nature, severity, and outcomes of all adverse events and pregnancies (composite outcome measure) | Up to 2.5 years |
| Total response rate | Up to 2.5 years |
| Two-year progression-free survival rate for patients with follicular lymphoma under maintenance therapy | 2 years |
Countries
Germany
Outcome results
None listed