A Phase 3 interventional study of Rituximab and Cyclophosphamide in Follicular Lymphoma, sponsored by University of Liverpool. Completed at 73 sites in United Kingdom. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by University of Liverpool · Phase 3, Interventional, and Treatment
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).
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.
5,577 studies on the registry are indexed under Lymphoma; 824 are open to participants now.
This study's enrollment of 680 is above the median of 40 across 4,507 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →University of Liverpool is the lead sponsor of 99 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Repeated every 21 days for up to 8 cycles with response assessment after 4 cycles. Responders (PR/CR) after 8 cycles will receive Rituximab maintenance therapy for 2 years (12 bi-monthly cycles).
Drug: Rituximab · Drug: Cyclophosphamide · Drug: Vincristine · Drug: Prednisolone
Repeated every 21 days for 4 cycles. Responders (PR/CR) after 4 cycles will receive 4 further cycles of Rituximab only. Responders after 8 cycles will receive Rituximab maintenance therapy for 2 years (12 bi-monthly cycles).
Drug: Cyclophosphamide · Drug: Fludarabine
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).
Also known as: Mabthera
Cyclophosphamide 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)
Also known as: Cyclophosphamide monohydrate
Vincristine 1.4mg/m2 IV day 1,repeated every 21 days for 8 cycles.
Also known as: vincristine sulfate
Prednisolone 40mg/m2 PO day 1-5, repeated every 21 days for 8 cycles.
Also known as: Deltacortril
Fludarabine 40mg/m2 PO day 1-3,repeated every 21 days for 4 cycles
Also known as: Fludara
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.
Time frame: 36 months
Progression-free survival
Time frame: 30 months
Response rates (overall, complete and partial) following initial therapy
Time frame: 24 weeks
Response rates following maintenance therapy
Time frame: 30 months
Response duration
Time frame: 30 months
Overall survival
Time frame: End of study
Time to next treatment
Time frame: End of study
Rate of large cell transformation
Time frame: End of study
Response to second-line therapy
Time frame: 30 months
Number of treatment cycles delivered
Time frame: 30 months
Cumulative dose of individual drugs administered
Time frame: 30 months
Quality of life
Time frame: End of study
Cost effectiveness
Time frame: End of study
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University of Liverpool