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

Roche

Status: Completed

Conditions: Lymphocytic Leukemia, Chronic

Treatments: Drug: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT01178086

ML22610

Details and patient eligibility

About

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.

Enrollment: 681 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CLL requiring treatment
• Participants receiving a chemotherapy in combination with rituximab (decision taken by doctor prior to and independent from inclusion in this non-interventional study)
• After this trial started, an amendment to the study protocol was introduced, adding a further inclusion criterion: Comorbidities according to cumulative illness rating scale (CIRS) score greater than (>) 6 and/or creatinine clearance less than (<) 70 milliliters per minute (mL/min)

Exclusion criteria

• Participants with contraindication to rituximab treatment

Trial design

681 participants in 1 patient group

Participants With CLL

Description:

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.

Treatment:

Drug: Rituximab