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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01178086
First Posted: August 9, 2010
Last Update Posted: December 11, 2017
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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
Lymphocytic Leukemia, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study on Rituximab in the Therapy of Chronic Lymphocytic Leukemia (CLL NIS)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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

Enrollment: 703
Study Start Date: February 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

  Eligibility

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
Criteria

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
  Contacts and Locations
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


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01178086     History of Changes
Other Study ID Numbers: ML22610
First Submitted: August 6, 2010
First Posted: August 9, 2010
Last Update Posted: December 11, 2017
Last Verified: November 2016

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