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Clinical Trials/NCT01724294
NCT01724294
Terminated
Not 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

Hoffmann-La Roche0 sites113 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diffuse Large B-Cell Lymphoma
Sponsor
Hoffmann-La Roche
Enrollment
113
Primary Endpoint
Treatment patterns in clinical practice: Number of treatment cycles received
Status
Terminated
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
April 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

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