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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01178086
First received: August 6, 2010
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This observational study will assess the therapeutic efficiency, the treatment s chedules and handling procedures, and the safety profile of MabThera/Rituxan (ri tuximab) in routine care in patients with chronic lymphocytic leukemia. Data fro m 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]

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

  Eligibility

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

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
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: NCT01178086

Locations
Germany
Frechen, Germany, 50226
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: NCT01178086     History of Changes
Other Study ID Numbers: ML22610
Study First Received: August 6, 2010
Last Updated: September 22, 2014
Health Authority: Germany: Paul-Ehrlich Institute

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on October 01, 2014