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An Observational Study on MabThera/Rituxan (Rituximab) in Patients With Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01178086
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational study will assess the therapeutic efficiency, the treatment schedules and handling procedures, and the safety profile of MabThera/Rituxan (rituximab) in routine care in patients with chronic lymphocytic leukemia. Data from patients will be collected for a total of 24 months.

Condition or disease
Lymphocytic Leukemia, Chronic

Study Type : Observational
Actual Enrollment : 703 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study on Rituximab in the Therapy of Chronic Lymphocytic Leukemia (CLL NIS)
Study Start Date : February 2010
Primary Completion Date : June 2015
Study Completion Date : June 2015


Primary Outcome Measures :
  1. Therapeutic efficiency: Rate of progression-free survival after 2 years in daily routine in patients with chronic lymphocytic leukemia on MabThera/Rituxan therapy [ Time Frame: 72 months ]

Secondary Outcome Measures :
  1. Ratio of disease progression to death of any cause within the composite endpoint progression-free survival [ Time Frame: 72 months ]
  2. Dosage/treatment schedule in routine clinical practice [ Time Frame: 72 months ]
  3. Safety: Incidence of adverse vents [ Time Frame: 72 months ]
  4. Progression-free survival: Comorbid versus unselected patient cohort [ Time Frame: 72 months ]
  5. Safety: Incidence of adverse events comorbid versus unselected patient cohort [ Time Frame: 72 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic lymphocytic leukemia on chemotherapy receiving MabThera/Rituxan

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic lymphocytic leukemia requiring treatment
  • Patients receive a chemotherapy in combination with MabThera/Rituxan (decision taken by doctor prior to and independent from inclusion in this non-interventional study)
  • Comorbidities according to CIRS score >6 and/or creatinine clearance <70 ml/min

Exclusion Criteria:

  • Unable or unwilling to give informed consent
  • Contraindication to MabThera/Rituxan

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 ClinicalTrials.gov identifier (NCT number): NCT01178086

Frechen, Germany, 50226
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01178086     History of Changes
Other Study ID Numbers: ML22610
First Posted: August 9, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 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