A Multi Centre, Single Arm, Observational Study on Safety and Efficacy of MabThera Plus Chemotherapy as 1st Line Treatment in Patients With DLBCL or FL

Hoffmann-La Roche24 sites in 1 country314 target enrollmentJanuary 19, 2011

ConditionsDiffuse Large B-Cell Lymphoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diffuse Large B-Cell Lymphoma
Sponsor: Hoffmann-La Roche
Enrollment: 314
Locations: 24
Primary Endpoint: Safety: Incidence of adverse events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collected from each patient during the 6 months of induction treatment and for up to 3 years of follow-up.

Registry

clinicaltrials.gov

Start Date

January 19, 2011

End Date

July 15, 2016

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed CD20+ diffuse large B-cell lymphoma or follicular lymphoma
•Treatment with MabThera/Rituxan as per locally approved China package insert
•Documented patient with medical records

Exclusion Criteria

•Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma

Outcomes

Primary Outcomes

Safety: Incidence of adverse events

Time Frame: 4.5 years

Secondary Outcomes

Overall Survival, defined as time from 1st treatment to death of any cause(4.5 years)
Overall Response Rate (complete response + partial response)(4.5 years)
Progression-free survival, defined as time from first treatment to lymphoma progression or death(4.5 years)