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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01072240
Recruitment Status : Completed
First Posted : February 22, 2010
Last Update Posted : November 1, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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

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 : September 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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

Primary Outcome Measures :
  1. infusion-related adverse events [ Time Frame: data collection every 4-6 weeks for up to 6 months for each patient ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
CLL patients receiving standard of care rituximab infusions at haematological or medical clinics

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01072240

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
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01072240     History of Changes
Other Study ID Numbers: ML22754
First Posted: February 22, 2010    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents