A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic Leukemia

Sponsor
Hoffmann-La Roche
Study ID
NCT01609023
Status
Completed

Conditions

  • Lymphocytic Leukemia, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice.

Study Details

This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.

Key Dates

Start date
Apr 30, 2012
Status verified
Apr 2018
Primary completion
Nov 30, 2015
Completion
Nov 30, 2015

Study Design

Enrollment
67 participants (actual)

Arms

  • Arm: Rituximab
    Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to SPC and routine clinical practice will be observed for 24 months.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to 24 months ]

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