NCT01724294TerminatedNot Applicable
Non-interventional, Post-marketing Study to Evaluate the Correlation Between Clinical and Biological Factors and IPI as Prognostic Factors in Patients With DLBCL in First Line Treatment With R-CHOP
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 113
- Primary Endpoint
- Treatment patterns in clinical practice: Number of treatment cycles received
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients, >18 years of age
- •Patients with diagnosed diffuse large B-cell lymphoma in first-line treatment with R-CHOP
Exclusion Criteria
- •Prior chemotherapy treatment for diffuse large B-cell lymphoma
- •Contra-indications or exclusion criteria according to the Summary of Product Characteristics for MabThera/Rituxan
Outcomes
Primary Outcomes
Treatment patterns in clinical practice: Number of treatment cycles received
Time Frame: approximately 4 years
Secondary Outcomes
- Response rates(approximately 4 years)
- Safety: Incidence of adverse events(approximately 4 years)
- Event-free survival(approximately 4 years)
Investigators
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