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

An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01072240

Enrollment

Registered

2010-02-22

Start date

2009-09-30

Completion date

2011-06-30

Last updated

2016-11-01

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 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.

Interventions

DRUGrituximab [Mabthera/Rituxan]

As prescribed by physician

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 * 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

Exclusion criteria

* participation in an interventional clinical study

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

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