NCT01303887

A Trial Looking at Rituximab and Chemotherapy as a Treatment for Follicular Lymphoma in Elderly Patients

Purine-Alkylator Combination In Follicular Lymphoma Immuno-Chemotherapy for Older Patients: a Phase III Comparison of First-line R-CVP Versus R-FC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 680 (actual)
• Sponsor: University of Liverpool · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether R-FC is more beneficial that R-CVP in the treatment of older patients (aged 60 or over) with Follicular Lymphoma (FL).

Detailed description

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.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab 375mg/m2 IV day 1,repeated every 21 days for 8 cycles. All patients who have achieved a CR or PR to induction therapy will receive rituximab maintenance (375mg/m2 every 2 months for 2 years).
DRUG	Cyclophosphamide	Cyclophosphamide 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)
DRUG	Vincristine	Vincristine 1.4mg/m2 IV day 1,repeated every 21 days for 8 cycles.
DRUG	Prednisolone	Prednisolone 40mg/m2 PO day 1-5, repeated every 21 days for 8 cycles.
DRUG	Fludarabine	Fludarabine 40mg/m2 PO day 1-3,repeated every 21 days for 4 cycles

Timeline

• Start date: 2009-10-01
• Primary completion: 2023-05-11
• Completion: 2023-05-11
• First posted: 2011-02-25
• Last updated: 2025-04-18

Locations

73 sites across 1 country: United Kingdom