Trials / Completed
CompletedNCT02013817
CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
CHAIROS - Effect of Early Brief Intensification by Chemoimmunotherapy With FCR Followed by FR and Rituximab Maintenance on Clinical Response in Chemo-naïve Patients With B-CLL
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rituximab [MabThera/Rituxan] | Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8 |
| DRUG | fludarabine | Every 4 weeks, 6 cycles |
| DRUG | cyclophosphamide | Every 4 weeks, 3 cycles |
Timeline
- Start date
- 2005-10-11
- Primary completion
- 2012-09-24
- Completion
- 2012-09-24
- First posted
- 2013-12-17
- Last updated
- 2017-08-18
- Results posted
- 2014-09-10
Locations
8 sites across 1 country: Austria
Source: ClinicalTrials.gov record NCT02013817. Inclusion in this directory is not an endorsement.