Status:
COMPLETED
A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Lymphocytic Leukemia, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- Participants with contraindication to rituximab treatment
Key Trial Info
Start Date :
February 22 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2015
Estimated Enrollment :
681 Patients enrolled
Trial Details
Trial ID
NCT01178086
Start Date
February 22 2010
End Date
June 30 2015
Last Update
October 5 2018
Active Locations (1)
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1
PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann
Frechen, Germany, 50226