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
Conditions
Lymphocytic Leukemia, Chronic
Treatments
Drug: Chemotherapy
Drug: rituximab [MabThera/Rituxan]
Details and patient eligibility
About
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.
Enrollment
219 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
219 participants in 2 patient groups
First line
Treatment:
Drug: rituximab [MabThera/Rituxan]
Drug: Chemotherapy
Relapsed/refractory
Treatment:
Drug: rituximab [MabThera/Rituxan]
Drug: Chemotherapy
Trial contacts and locations
55
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Data sourced from clinicaltrials.gov
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