At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicentre, Non-Randomised, Open-Label Phase II Study to Evaluate the Efficacy and Safety of Induction Treatment With Rituximab, Fludarabine, Cyclophosphamide, Followed by Rituximab Maintenance Therapy (R-Fc-Rm) in the First Line Treatment of Chronic Lymphocytic Leukaemia
In Brief
A Phase 2 clinical trial evaluating Cyclophosphamide, Fludarabine, and 1 other intervention for Leukemia, Lymphocytic, Chronic, B-Cell. Completed, enrolled 86 participants across 33 sites.
Detailed Summary
This single arm study will assess the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line treatment of participants with CLL.
Study Details
Timeline
Interventions
Cyclophosphamide 250 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
Fludarabine 25 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
Rituximab 375 mg/m\^2 as IV infusion will be administered on Day 0 of Cycle 1; 500 mg/m\^2 as IV infusion will be administered on Day 1 of Cycle 2-6; and 375 mg/m\^2 as IV infusion every 2 months from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.