An Observational Study of MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in First-Line in Patients With Diffuse Large B-Cell Lymphoma
- Conditions
- Diffuse Large B-Cell Lymphoma
- Registration Number
- NCT01724294
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multicenter, observational study will evaluate the correlation between clinical and biological factors and International Prognostic Index (IPI) as prognostic factors in patients with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment according to standard of care and local guidelines will be followed for the duration of treatment (approximately 8 months) and during 1 year of follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 113
- Adult patients, >18 years of age
- Patients with diagnosed diffuse large B-cell lymphoma in first-line treatment with R-CHOP
- Prior chemotherapy treatment for diffuse large B-cell lymphoma
- Contra-indications or exclusion criteria according to the Summary of Product Characteristics for MabThera/Rituxan
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment patterns in clinical practice: Number of treatment cycles received approximately 4 years
- Secondary Outcome Measures
Name Time Method Response rates approximately 4 years Safety: Incidence of adverse events approximately 4 years Event-free survival approximately 4 years