An Observational Study of MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in First-Line in Patients With Diffuse Large B-Cell Lymphoma

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01724294
• Other study ID #: ML28497
• Status: Terminated
• Phase: N/A
• First received: November 7, 2012
• Last updated: November 1, 2016
• Start date: December 2012
• Est. completion date: April 2016

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Agency for Medicines and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 113
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment patterns in clinical practice: Number of treatment cycles received		approximately 4 years	No
Secondary	Event-free survival		approximately 4 years	No
Secondary	Response rates		approximately 4 years	No
Secondary	Safety: Incidence of adverse events		approximately 4 years	No