Trials / Completed
CompletedNCT01118234
Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)
International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 256 (actual)
- Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab | Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2018-02-01
- Completion
- 2019-07-01
- First posted
- 2010-05-06
- Last updated
- 2020-01-09
Locations
22 sites across 3 countries: Austria, Czechia, Slovakia
Source: ClinicalTrials.gov record NCT01118234. Inclusion in this directory is not an endorsement.