A Trial Looking at Rituximab and Chemotherapy as a Treatment for Follicular Lymphoma in Elderly Patients
PACIFICO
Purine-Alkylator Combination In Follicular Lymphoma Immuno-Chemotherapy for Older Patients: a Phase III Comparison of First-line R-CVP Versus R-FC
2 other identifiers
interventional
680
1 country
73
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2009
Longer than P75 for phase_3
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 24, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2023
CompletedApril 18, 2025
April 1, 2025
13.6 years
February 24, 2011
April 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Progression-free survival
30 months
Secondary Outcomes (11)
Response rates (overall, complete and partial) following initial therapy
24 weeks
Response rates following maintenance therapy
30 months
Response duration
30 months
Overall survival
End of study
Time to next treatment
End of study
- +6 more secondary outcomes
Study Arms (2)
R-CVP
ACTIVE COMPARATORRepeated 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).
R-FC
EXPERIMENTALRepeated 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).
Interventions
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 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)
Vincristine 1.4mg/m2 IV day 1,repeated every 21 days for 8 cycles.
Prednisolone 40mg/m2 PO day 1-5, repeated every 21 days for 8 cycles.
Fludarabine 40mg/m2 PO day 1-3,repeated every 21 days for 4 cycles
Eligibility Criteria
You may qualify if:
- Histologically confirmed follicular lymphoma (grade 1,2, and 3a with material available for central review)
- Ann Arbor stage II-IV
- Aged 60 years or over, or aged less than 60 but anthracycline-based therapy contra-indicated
- No prior systemic therapy (one episode of prior local radiotherapy is allowed)
- At least one of the following criteria for initiation of treatment:
- Rapid generalized disease progression in the preceding 3 months
- Life threatening organ involvement
- Renal or macroscopic liver infiltration
- Bone lesions
- Presence of systemic symptoms or pruritus
- Haemoglobin \< 10 g/dL or WBC \< 3.0 Ă— 109/L or platelet counts \< 100 Ă— 109/L due to marrow involvement
- Adequate haematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow):
- Haemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- +1 more criteria
You may not qualify if:
- Overt transformation to diffuse large B-cell lymphoma
- Grade 3b follicular lymphoma
- Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis)
- WHO performance status 3 or 4
- Impaired renal function defined as estimated Glomerular filtration rate (eGFR) \< 30 mL/min using the Modification of Diet in Renal Disease (MDRD) formula
- Impaired hepatic function defined as serum bilirubin more than twice upper limit of normal (unless due to lymphoma or Gilbert's syndrome)
- Life expectancy less than 12 months
- Pre-existing neuropathy
- Active auto-immune haemolytic anaemia
- Serological evidence of infection with HIV, hepatitis B (positivity for surface antigen or core antibody) or hepatitis C
- Allergy to murine proteins
- Corticosteroid treatment during the last 4 weeks, unless administered at a dose equivalent to no more than prednisolone 20mg/day continuously or a single course of prednisolone 1 mg/kg for up to 7 days
- Concomitant malignancies except adequately treated localised non-melanoma skin cancer or adequately treated in situ cervical cancer, or cancers that have been in remission for at least 5 years following surgery with curative intent.
- Major surgery (excluding lymph node biopsy) within 28 days prior to randomisation
- Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Liverpoollead
- Liverpool University Hospitals NHS Foundation Trustcollaborator
- Cancer Research UKcollaborator
- Roche Pharma AGcollaborator
Study Sites (73)
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Ysbyty Gwynedd
Bangor, United Kingdom
Birmingham Heartlands
Birmingham, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Frenchay Hospital
Bristol, United Kingdom
Queen's Hospital, Burton
Burton-on-Trent, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Kent and Canterbury Hospital
Canterbury, United Kingdom
Velindre Hospital
Cardiff, United Kingdom
Countess of Chester
Chester, United Kingdom
Leighton Hospital
Crewe, United Kingdom
Trafford General Hospital
Davyhulme, United Kingdom
Russels Hall Hospital
Dudley, United Kingdom
Royal Devon & Exeter Hospital
Exeter, United Kingdom
Falkirk & District Royal Infirmary
Falkirk, United Kingdom
Queen Elizabeth Hospital
Gateshead, United Kingdom
Medway Maritime Hospital
Gillingham, United Kingdom
Beatson Oncology Centre
Glasgow, United Kingdom
Royal Alexandra Hospital
Glasgow, United Kingdom
Harrogate District Foundation Trust
Harrogate, United Kingdom
Northwick Park Hospital
Harrow, United Kingdom
Princess Royal Hospital, Bromley
Hayes, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, United Kingdom
Castle Hill Hospital
Hull, United Kingdom
Raigmore Hospital,
Inverness, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
Kettering General Hospital
Kettering, United Kingdom
The Queen Elizabeth Hospital, Kings Lynn
Kings Lynn, United Kingdom
St James University Hospital
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
University Hospital Aintree
Liverpool, United Kingdom
Guys & St Thomas Hospital
London, United Kingdom
Kings College Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
St Bartholomews Hospital
London, United Kingdom
University College Hospital
London, United Kingdom
Altnagelvin Hospital
Londonderry, United Kingdom
Luton & Dunstable Hospital
Luton, United Kingdom
Kent Oncology Centre
Maidstone, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Arrowe Park Hospital
Metropolitan Borough of Wirral, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Northampton General Hospital
Northampton, United Kingdom
Mount Vernon Hospital
Northwood, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Whiston Hospital
Prescot, United Kingdom
Queens Hospital
Romford, United Kingdom
Salford Royal Hospital
Salford, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Diana Princess of Wales Hospital
Scunthorpe, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Wexham Park Hospital
Slough, United Kingdom
South Tyneside District General Hospital
South Shields, United Kingdom
Basingstoke and North Hampshire Hospital
Southampton, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
St Richards Hospital
Southampton, United Kingdom
Glan Clwyd Hospital
St Asaph, United Kingdom
Stafford District General Hospital
Stafford, United Kingdom
Lister Hospital
Stevenage, United Kingdom
Sunderland Royal Hospital
Sunderland, United Kingdom
Great Western Hospital
Swindon, United Kingdom
Torbay District General Hospital
Torquay, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Hillingdon Hospital
Uxbridge, United Kingdom
Pinderfields General Hospital
Wakefield, United Kingdom
West Herts
Watford, United Kingdom
Worcestershire Acute Hospitals NHS Trust
Worcester, United Kingdom
Worthing Hospital
Worthing, United Kingdom
York District Hospital
York, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Pettitt, Professor
University of Liverpool and Royal Liverpool and Broadgreen University Hospitals Trust
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2011
First Posted
February 25, 2011
Study Start
October 1, 2009
Primary Completion
May 11, 2023
Study Completion
May 11, 2023
Last Updated
April 18, 2025
Record last verified: 2025-04