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.
1 other identifier
observational
92
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2009
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedNovember 1, 2016
October 1, 2016
1.7 years
February 8, 2010
October 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
infusion-related adverse events
data collection every 4-6 weeks for up to 6 months for each patient
Secondary Outcomes (1)
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
Study Arms (1)
Cohort
Interventions
Eligibility Criteria
CLL patients receiving standard of care rituximab infusions at haematological or medical clinics
You may qualify if:
- 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
You may not qualify if:
- participation in an interventional clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Gävle, 80187, Sweden
Unknown Facility
Gothenburg, SE-41 343, Sweden
Unknown Facility
Huddinge, 14186, Sweden
Unknown Facility
Jönköping, 551_85, Sweden
Unknown Facility
Kalmar, 39185, Sweden
Unknown Facility
Karlstad, 65185, Sweden
Unknown Facility
Kristianstad, 29185, Sweden
Unknown Facility
Lidköping, S-53131, Sweden
Unknown Facility
Linköping, 581 85, Sweden
Unknown Facility
Luleå, S-971 80, Sweden
Unknown Facility
Mora, S-79285, Sweden
Unknown Facility
Norrköping, 60182, Sweden
Unknown Facility
Oskarshamn, 57251, Sweden
Unknown Facility
Stockholm, 17176, Sweden
Unknown Facility
Sundsvall, 85186, Sweden
Unknown Facility
Umeå, 901 85, Sweden
Unknown Facility
Västervik, 59381, Sweden
Unknown Facility
Visby, 62184, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 22, 2010
Study Start
September 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
November 1, 2016
Record last verified: 2016-10