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

Lymphocytic Leukemia, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072240
• Other study ID #: ML22754
• Status: Completed
• Phase: N/A
• First received: February 8, 2010
• Last updated: October 29, 2016
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphocytic Leukemia, Chronic

Intervention

Drug:
• rituximab [Mabthera/Rituxan]
As prescribed by physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infusion-related adverse events		data collection every 4-6 weeks for up to 6 months for each patient	Yes
Secondary	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	No