Lymphocytic Leukemia, Chronic
Conditions
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.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Complete response rate | 2 years |
| Progression-free survival | 2 years |
| Time to next treatment | 2 years |
| Overall survival | 2 years |
| Overall response rate | 2 years |
| Safety (incidence of hematologic adverse events) | 2 years |
| Safety (incidence of infections) | 2 years |
| Safety (incidence of secondary malignancies) | 2 years |
| Safety (incidence of adverse events) | 2 years |
Countries
France
Outcome results
None listed