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

Sponsor
University of Liverpool
Study ID
NCT01303887
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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).
  • Cyclophosphamide — DRUG
    Cyclophosphamide 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)
  • Vincristine — DRUG
    Vincristine 1.4mg/m2 IV day 1,repeated every 21 days for 8 cycles.
  • Prednisolone — DRUG
    Prednisolone 40mg/m2 PO day 1-5, repeated every 21 days for 8 cycles.
  • Fludarabine — DRUG
    Fludarabine 40mg/m2 PO day 1-3,repeated every 21 days for 4 cycles

Study Details

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).

Key Dates

Start date
Oct 31, 2009
Status verified
Apr 2025
Primary completion
May 11, 2023
Completion
May 11, 2023

Study Design

Enrollment
680 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: R-CVP
    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).
  • Experimental: R-FC
    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).

Primary Outcome Measure

Toxicity [ Time Frame: 36 months ]

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