An Open Label Study to Assess the Effect of First Line Treatment With MabThera in Combination With Fludarabine and Cyclophosphamide, Followed by MabThera Monotherapy, on Response Rate in Patients With Chronic Lymphocytic Leukemia.
Phase 2
18 Years
70 Years
18 Years
70 Years
Open (Enrolling)
Both
Lymphocytic Leukemia, Chronic
Both
Lymphocytic Leukemia, Chronic
Trial Information
An Open Label Study to Assess the Effect of First Line Treatment With MabThera in Combination With Fludarabine and Cyclophosphamide, Followed by MabThera Monotherapy, on Response Rate in Patients With Chronic Lymphocytic Leukemia.
Inclusion Criteria:
- adult patients, 18-70 years of age;
- CD20-positive B-cell chronic lymphocytic leukemia;
- active disease;
- no previous treatment.
Exclusion Criteria:
- transformation to aggressive B-cell malignancy;
- history of other malignancies except for localised skin cancer;
- continuous systemic corticosteroid treatment;
- known infection with hepatitis B or C.
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:
Response rate, and percentage of patients with molecular remission
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
Study ID:
ML21135
NCT ID:
NCT00545714
Start Date:
November 2007
Completion Date:
April 2016
Related Keywords:
- Lymphocytic Leukemia, Chronic
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Chronic Disease
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