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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 6, 2010
Last updated: October 1, 2015
Last verified: October 2015

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.

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ratio of disease progression to death of any cause within the composite endpoint progression-free survival [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Dosage/treatment schedule in routine clinical practice [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse vents [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Progression-free survival: Comorbid versus unselected patient cohort [ Time Frame: 72 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events comorbid versus unselected patient cohort [ Time Frame: 72 months ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 identifier: NCT01178086

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

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01178086     History of Changes
Other Study ID Numbers: ML22610
Study First Received: August 6, 2010
Last Updated: October 1, 2015
Health Authority: Germany: Paul-Ehrlich Institute

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on October 13, 2015