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

October 29, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gaevle, Sweden, 80187
      • Gothenburg, Sweden, SE-41 343
      • Huddinge, Sweden, 14186
      • Jönköping, Sweden, 551_85
      • Kalmar, Sweden, 39185
      • Karlstad, Sweden, 65185
      • Kristianstad, Sweden, 29185
      • Lidköping, Sweden, S-53131
      • Linkoeping, Sweden, 581 85
      • Luleå, Sweden, S-971 80
      • Mora, Sweden, S-79285
      • Norrkoeping, Sweden, 60182
      • Oskarshamn, Sweden, 57251
      • Stockholm, Sweden, 17176
      • Sundsvall, Sweden, 85186
      • Umea, Sweden, 901 85
      • Visby, Sweden, 62184
      • Västervik, Sweden, 59381

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

CLL patients receiving standard of care rituximab infusions at haematological or medical clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Drug: rituximab [Mabthera/Rituxan]
As prescribed by physician

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (Estimate)

February 22, 2010

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 29, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22754

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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