Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)
NCT01118234 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256
Last updated 2020-01-09
Summary
The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.
Conditions
Interventions
- DRUG
-
Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation
Sponsors & Collaborators
-
Roche Pharma AG
collaborator INDUSTRY -
Arbeitsgemeinschaft medikamentoese Tumortherapie
lead OTHER
Principal Investigators
-
Richard Greil, Prof. Dr. · Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-12-31
- Primary Completion
- 2018-02-28
- Completion
- 2019-07-31
Countries
- Austria
- Czechia
- Slovakia
Study Locations
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