Trial Information
A Multicentre, Observational, Prospective Study to Assess the Safety Profile of Rituximab in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (B-CLL)
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- B cell-lineage chronic lymphocytic leukaemia (B-CLL)
- Prescribed with MabThera/Rituxan in combination with chemotherapy according to the
approved SMPC
- Informed consent to data collection
Exclusion Criteria:
- Treatment with any marketed or non-marketed drug substance or experimental therapy
within 4 weeks prior to first dose of study drug or participation in a clinical trial
within 30 days prior to entering this study
- Any other tumour disease
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Spain: Ministry of Health
Study ID:
ML25372
NCT ID:
NCT01224093
Start Date:
October 2010
Completion Date:
January 2014
Related Keywords:
- Lymphocytic Leukemia, Chronic
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Chronic Disease