An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia

Completed

• Conditions: Lymphocytic Leukemia, Chronic
• Interventions: Drug: rituximab [Mabthera/Rituxan]

• Registration Number: NCT01072240
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with MabThera (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of 375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6 months. Target sample size is 100 patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-22
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-29
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• adult patients, >/= 18 years of age
• chronic lymphocytic leukemia treated with rituximab (MabThera)
• rituximab (MabThera) dosage 375 mg/m2 in cycle 1, 500 mg/m2 in subsequent cycles
• informed consent to data collection

Read More

Exclusion Criteria

• participation in an interventional clinical study

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	rituximab [Mabthera/Rituxan]	-

Primary Outcome Measures

Name	Time	Method
infusion-related adverse events	data collection every 4-6 weeks for up to 6 months for each patient

Secondary Outcome Measures

Name	Time	Method
usage and applicability of 90-minute iv infusion in patients with CLL	data collection every 4-6 weeks for up to 6 months for each patient