An Open-label Study to Characterize the Safety and Response Rate of MabThera (Rituximab) Plus Chlorambucil in Previously Untreated Patients With CD20-positive B-cell Chronic Lymphocytic Leukemia
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Lymphocytic Leukemia, Chronic
Both
Lymphocytic Leukemia, Chronic
Trial Information
An Open-label Study to Characterize the Safety and Response Rate of MabThera (Rituximab) Plus Chlorambucil in Previously Untreated Patients With CD20-positive B-cell Chronic Lymphocytic Leukemia
Inclusion Criteria:
- adult patients, >=18 years of age;
- previously untreated patients with CD20-positive B-cell chronic lymphocytic leukemia;
- patients with progressive Binet stage B, or C requiring therapy according to NCI
criteria;
- ECOG performance status <=2.
Exclusion Criteria:
- previous treatment for CLL;
- known concomitant hematological malignancy;
- transformation to aggressive B-cell malignancy;
- history of severe cardiac disease;
- known hypersensitivity or anaphylactic reactions to murine antibodies.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
AE profile; laboratory parameters
Outcome Time Frame:
Throughout study
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
England: National Patient Safety Agency and Research Ethics Committees
Study ID:
MO20927
NCT ID:
NCT00532129
Start Date:
October 2007
Completion Date:
April 2012
Related Keywords:
- Lymphocytic Leukemia, Chronic
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Chronic Disease
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