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

NCT01303887 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2025-04-18

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Liverpool University Hospitals NHS Foundation Trust

    collaborator OTHER_GOV

  • Cancer Research UK

    collaborator OTHER

  • Roche Pharma AG

    collaborator INDUSTRY

  • University of Liverpool

    lead OTHER

Principal Investigators

  • Andrew Pettitt, Professor · University of Liverpool and Royal Liverpool and Broadgreen University Hospitals Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2023-05-11
Completion
2023-05-11

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303887 on ClinicalTrials.gov