A Multicentre, Observational, Prospective Study to Assess the Safety Profile of Rituximab in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (B-CLL)

Hoffmann-La Roche0 sites219 target enrollmentOctober 2010

ConditionsLymphocytic Leukemia, Chronic

InterventionsChemotherapy rituximab [MabThera/Rituxan]

DrugsChemotherapy rituximab [MabThera/Rituxan]

Overview

Phase: Not Applicable
Intervention: Chemotherapy
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Enrollment: 219
Primary Endpoint: Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

February 2014

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•B cell-lineage chronic lymphocytic leukaemia (B-CLL)
•Prescribed with MabThera/Rituxan in combination with chemotherapy according to the approved SMPC
•Informed consent to data collection

Exclusion Criteria

•Treatment with any marketed or non-marketed drug substance or experimental therapy within 4 weeks prior to first dose of study drug or participation in a clinical trial within 30 days prior to entering this study
•Any other tumour disease

Arms & Interventions

First line

Intervention: Chemotherapy

First line

Intervention: rituximab [MabThera/Rituxan]

Relapsed/refractory

Intervention: Chemotherapy

Relapsed/refractory

Intervention: rituximab [MabThera/Rituxan]

Outcomes

Primary Outcomes

Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients

Time Frame: 3 years

Secondary Outcomes

Efficacy (Response rate, duration of response, progression-free survival)(3 years)
Chronic lymphocytic leukaemia (CLL) Comorboid Scale(3 years)
Quality-adjusted survival analysis (Q-TWIST methodology)(3 years)