An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01072240
Collaborator
(none)
92
18
21
5.1
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
92 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.
Study Start Date
:
Sep 1, 2009
Actual Primary Completion Date
:
Jun 1, 2011
Actual Study Completion Date
:
Jun 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort
|
Drug: rituximab [Mabthera/Rituxan]
As prescribed by physician
|
Outcome Measures
Primary Outcome Measures
- infusion-related adverse events [data collection every 4-6 weeks for up to 6 months for each patient]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gaevle | Sweden | 80187 | ||
| 2 | Gothenburg | Sweden | SE-41 343 | ||
| 3 | Huddinge | Sweden | 14186 | ||
| 4 | Jönköping | Sweden | 551_85 | ||
| 5 | Kalmar | Sweden | 39185 | ||
| 6 | Karlstad | Sweden | 65185 | ||
| 7 | Kristianstad | Sweden | 29185 | ||
| 8 | Lidköping | Sweden | S-53131 | ||
| 9 | Linkoeping | Sweden | 581 85 | ||
| 10 | Luleå | Sweden | S-971 80 | ||
| 11 | Mora | Sweden | S-79285 | ||
| 12 | Norrkoeping | Sweden | 60182 | ||
| 13 | Oskarshamn | Sweden | 57251 | ||
| 14 | Stockholm | Sweden | 17176 | ||
| 15 | Sundsvall | Sweden | 85186 | ||
| 16 | Umea | Sweden | 901 85 | ||
| 17 | Visby | Sweden | 62184 | ||
| 18 | Västervik | Sweden | 59381 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01072240
Other Study ID Numbers:
- ML22754
First Posted:
Feb 22, 2010
Last Update Posted:
Nov 1, 2016
Last Verified:
Oct 1, 2016
Additional relevant MeSH terms: