Purine-Alkylator Combination In Follicular Lymphoma Immuno-Chemotherapy for Older Patients: a Phase III Comparison of First-line R-CVP Versus R-FC
FL predominantly affects the elderly, yet the optimum treatment for older patients with the
disease has not been defined. The present study aims to address this question by comparing
the drug combination that is currently considered the gold-standard (R-CVP) with a newer
combination (R-FC) that might be more effective without being significantly more toxic. In
order to take into account the balance between efficacy and toxicity, a dual primary
endpoint has been employed: progression-free survival and toxicity in the form of grade 3-4
infection.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity
The second primary outcome measure is grade 3-4 infection occurring anytime from the start of treatment until 6 months following the last dose of treatment, and this will be used as the toxicity end-point. Toxicity will be measured according to standard National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 following each cycle of treatment and at each subsequent follow-up visit until 6 months following the last dose of treatment.
36 months
Yes
Andrew Pettitt, Professor
Principal Investigator
University of Liverpool and Royal Liverpool and Broadgreen University Hospitals Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency
ISRCTN99217456
NCT01303887
October 2009
September 2016
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