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)

Completed

• Conditions: Lymphocytic Leukemia, Chronic
• Interventions: Drug: Chemotherapy; Drug: rituximab [MabThera/Rituxan]

• Registration Number: NCT01224093
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relapsed/refractory	rituximab [MabThera/Rituxan]	-
First line	rituximab [MabThera/Rituxan]	-
First line	Chemotherapy	-
Relapsed/refractory	Chemotherapy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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