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

NCT ID: NCT01072240

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Lymphocytic Leukemia, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

rituximab [Mabthera/Rituxan]

Intervention Type DRUG

As prescribed by physician

Interventions

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rituximab [Mabthera/Rituxan]

As prescribed by physician

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Gävle, , Sweden

Site Status

Gothenburg, , Sweden

Site Status

Huddinge, , Sweden

Site Status

Jönköping, , Sweden

Site Status

Kalmar, , Sweden

Site Status

Karlstad, , Sweden

Site Status

Kristianstad, , Sweden

Site Status

Lidköping, , Sweden

Site Status

Linköping, , Sweden

Site Status

Luleå, , Sweden

Site Status

Mora, , Sweden

Site Status

Norrköping, , Sweden

Site Status

Oskarshamn, , Sweden

Site Status

Stockholm, , Sweden

Site Status

Sundsvall, , Sweden

Site Status

Umeå, , Sweden

Site Status

Västervik, , Sweden

Site Status

Visby, , Sweden

Site Status

Countries

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United States Sweden

Other Identifiers

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ML22754

Identifier Type: -

Identifier Source: org_study_id