Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia

Completed

• Conditions: Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Cancer

• Registration Number: NCT02461316
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients older than 18 years with diagnosed Chronic Lymphocytic Leukemia (CLL)
• CLL stages: Binet stage C (Rai III or IV), Binet stage B (Rai I and II) requiring treatment

Exclusion Criteria

• Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Adverse Events (AEs)	From baseline to end of study up to 18 months
Percentage of Serious Adverse Events (SAEs)	From baseline to end of study up to 18 months