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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01072240
First received: February 8, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 Intervention
Lymphocytic Leukemia, Chronic
Drug: rituximab [Mabthera/Rituxan]

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • infusion-related adverse events [ Time Frame: data collection every 4-6 weeks for up to 6 months for each patient ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Drug: rituximab [Mabthera/Rituxan]
As prescribed by physician

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072240

Locations
Sweden
Gaevle, Sweden, 80187
Goteborg, Sweden, 40036
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01072240     History of Changes
Other Study ID Numbers: ML22754
Study First Received: February 8, 2010
Last Updated: March 3, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014