Trial Information
Non-interventional Study on Rituximab in the Therapy of Chronic Lymphocytic Leukemia (CLL NIS)
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Chronic lymphocytic leukemia requiring treatment
- Patients receive a chemotherapy in combination with MabThera/Rituxan (decision taken
by doctor prior to and independent from inclusion in this non-interventional study)
- Comorbidities according to CIRS score >6 and/or creatinine clearance <70 ml/min
Exclusion Criteria:
- Unable or unwilling to give informed consent
- Contraindication to MabThera/Rituxan
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Therapeutic efficiency: Rate of progression-free survival after 2 years in daily routine in patients with chronic lymphocytic leukemia on MabThera/Rituxan therapy
Outcome Time Frame:
72 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Germany: Paul-Ehrlich Institute
Study ID:
ML22610
NCT ID:
NCT01178086
Start Date:
February 2010
Completion Date:
June 2015
Related Keywords:
- Lymphocytic Leukemia, Chronic
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Chronic Disease