At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 43 enrolled
Drug / intervention
rituximab [MabThera/Rituxan] +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating rituximab [MabThera/Rituxan], fludarabine, and 1 other intervention for Lymphocytic Leukemia, Chronic. Completed, enrolled 43 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphocytic Leukemia, Chronic
CountriesAustria
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2005
Primary CompletionSep 2012
First PostedDec 2013
TodayJul 2026
First PostedDec 17, 2013
Enrollment StartOct 11, 2005
Primary CompletionSep 24, 2012
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 12.5 years ago
Interventions
rituximab [MabThera/Rituxan]drug
Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8
fludarabinedrug
Every 4 weeks, 6 cycles
cyclophosphamidedrug
Every 4 weeks, 3 cycles