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)

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01224093

Enrollment

219

Registered

2010-10-19

Start date

2010-10-31

Completion date

2014-02-28

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphocytic Leukemia, Chronic

Brief 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.

Interventions

DRUGChemotherapy

as prescribed

DRUGrituximab [MabThera/Rituxan]

as prescribed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients	3 years

Secondary

Measure	Time frame
Efficacy (Response rate, duration of response, progression-free survival)	3 years
Chronic lymphocytic leukaemia (CLL) Comorboid Scale	3 years
Quality-adjusted survival analysis (Q-TWIST methodology)	3 years

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026