A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

Sponsor
Hoffmann-La Roche
Study ID
NCT01178086
Status
Completed

Conditions

  • Lymphocytic Leukemia, Chronic

Eligibility Criteria

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

Interventions

Study Details

This observational study will assess the therapeutic efficiency, treatment schedules, handling procedures, and the safety profile of rituximab in routine care in participants with CLL.

Key Dates

Start date
Feb 22, 2010
Status verified
Dec 2017
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
681 participants (actual)

Arms

  • Arm: Participants With CLL
    Participants with CLL who are being treated with intravenous (IV) rituximab in combination with chemotherapy, will be observed for 24 months including 6-month treatment period.

Primary Outcome Measure

Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate [ Time Frame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months) ]

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