Overview

An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC)

Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
Summary
This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Rituximab
Criteria
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