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An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01488162
First received: November 4, 2011
Last updated: March 21, 2017
Last verified: March 2017
November 4, 2011
March 21, 2017
April 4, 2011
October 24, 2016   (Final data collection date for primary outcome measure)
Chemotherapy regimens associated with MabThera/Rituxan in management of relapse/refractory CLL: Percentage of patients receiving purine analogues/bendamustine/alkylating agents/other chemotherapy [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01488162 on ClinicalTrials.gov Archive Site
  • Overall response rate [ Time Frame: 2 years ]
  • Complete response rate [ Time Frame: 2 years ]
  • Progression-free survival [ Time Frame: 2 years ]
  • Time to next treatment [ Time Frame: 2 years ]
  • Overall survival [ Time Frame: 2 years ]
  • Safety (incidence of adverse events) [ Time Frame: 2 years ]
  • Safety (incidence of hematologic adverse events) [ Time Frame: 2 years ]
  • Safety (incidence of infections) [ Time Frame: 2 years ]
  • Safety (incidence of secondary malignancies) [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia
Non Interventional Study Aimed to Describe the Management of Relapse or Refractory Chronic Lymphocytic Leukemia (CLL) Patients Retreated by MabThera
This multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2 years.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Adult patients with relapsing or refractory chronic lymphocytic leukemia (CLL)
Lymphocytic Leukemia, Chronic
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
327
October 24, 2016
October 24, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) with first or second relapse
  • Previous treatment with MabThera/Rituxan
  • MabThera/Rituxan treatment planned for current relapse

Exclusion Criteria:

  • Richter syndrome
  • Life expectancy <6 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01488162
ML25664
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP