An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia
Completed
- Conditions
- Lymphocytic Leukemia, Chronic
- Registration Number
- NCT01488162
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 327
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
Read More
Exclusion Criteria
- Richter syndrome
- Life expectancy <6 months
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chemotherapy regimens associated with MabThera/Rituxan in management of relapse/refractory CLL: Percentage of patients receiving purine analogues/bendamustine/alkylating agents/other chemotherapy 2 years
- Secondary Outcome Measures
Name Time Method Time to next treatment 2 years Overall survival 2 years Safety (incidence of infections) 2 years Safety (incidence of secondary malignancies) 2 years Safety (incidence of adverse events) 2 years Overall response rate 2 years Complete response rate 2 years Progression-free survival 2 years Safety (incidence of hematologic adverse events) 2 years