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Follicular LymphomaPhase 3PACIFICONCT01303887

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

A Phase 3 study testing Rituximab, Cyclophosphamide and Vincristine in people with Follicular Lymphoma, run by University of Liverpool at 73 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Rituximab, Cyclophosphamide and Vincristine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
680 participants
Where
73 sitesUnited Kingdom
Study dates
Oct 2009to 11 May 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 × 109/L or platelet counts < 100 × 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
  • Written Informed Consent

Who cannot join

  • 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)
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  • 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)
  • Treatment within a clinical trial within 30 days prior to trial entry
  • Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent
  • Adult patient under tutelage (not competent to sign informed consent)
  • Pregnant or lactating women
  • All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom

Trial locations and contacts

73 sites in 1 country.

73 sites in 1 country

United Kingdom73 sites

  • Aberdeen Royal Infirmary

    Aberdeen

  • Ysbyty Gwynedd

    Bangor

  • Birmingham Heartlands

    Birmingham

  • Royal Bournemouth Hospital

    Bournemouth

  • Bradford Royal Infirmary

    Bradford

  • Frenchay Hospital

    Bristol

  • Queen's Hospital, Burton

    Burton-on-Trent

  • Addenbrookes Hospital

    Cambridge

  • Kent and Canterbury Hospital

    Canterbury

  • Velindre Hospital

    Cardiff

  • Countess of Chester

    Chester

  • Leighton Hospital

    Crewe

  • Trafford General Hospital

    Davyhulme

  • Russels Hall Hospital

    Dudley

  • Royal Devon & Exeter Hospital

    Exeter

  • Falkirk & District Royal Infirmary

    Falkirk

  • Queen Elizabeth Hospital

    Gateshead

  • Medway Maritime Hospital

    Gillingham

  • Beatson Oncology Centre

    Glasgow

  • Royal Alexandra Hospital

    Glasgow

  • Harrogate District Foundation Trust

    Harrogate

  • Northwick Park Hospital

    Harrow

  • Princess Royal Hospital, Bromley

    Hayes

  • Huddersfield Royal Infirmary

    Huddersfield

  • Castle Hill Hospital

    Hull

  • Raigmore Hospital,

    Inverness

  • Ipswich Hospital

    Ipswich

  • Kettering General Hospital

    Kettering

  • The Queen Elizabeth Hospital, Kings Lynn

    Kings Lynn

  • St James University Hospital

    Leeds

  • Leicester Royal Infirmary

    Leicester

  • Royal Liverpool University Hospital

    Liverpool

  • University Hospital Aintree

    Liverpool

  • Guys & St Thomas Hospital

    London

  • Kings College Hospital

    London

  • Royal Free Hospital

    London

  • St Bartholomews Hospital

    London

  • University College Hospital

    London

  • Altnagelvin Hospital

    Londonderry

  • Luton & Dunstable Hospital

    Luton

  • Kent Oncology Centre

    Maidstone

  • Manchester Royal Infirmary

    Manchester

  • The Christie Hospital

    Manchester

  • Arrowe Park Hospital

    Metropolitan Borough of Wirral

  • Royal Victoria Infirmary

    Newcastle upon Tyne

  • Northampton General Hospital

    Northampton

  • Mount Vernon Hospital

    Northwood

  • Nottingham City Hospital

    Nottingham

  • Derriford Hospital

    Plymouth

  • Whiston Hospital

    Prescot

  • Queens Hospital

    Romford

  • Salford Royal Hospital

    Salford

  • Salisbury District Hospital

    Salisbury

  • Diana Princess of Wales Hospital

    Scunthorpe

  • Royal Hallamshire Hospital

    Sheffield

  • Wexham Park Hospital

    Slough

  • South Tyneside District General Hospital

    South Shields

  • Basingstoke and North Hampshire Hospital

    Southampton

  • Southampton General Hospital

    Southampton

  • St Richards Hospital

    Southampton

  • Glan Clwyd Hospital

    St Asaph

  • Stafford District General Hospital

    Stafford

  • Lister Hospital

    Stevenage

  • Sunderland Royal Hospital

    Sunderland

  • Great Western Hospital

    Swindon

  • Torbay District General Hospital

    Torquay

  • Royal Cornwall Hospital

    Truro

  • Hillingdon Hospital

    Uxbridge

  • Pinderfields General Hospital

    Wakefield

  • West Herts

    Watford

  • Worcestershire Acute Hospitals NHS Trust

    Worcester

  • Worthing Hospital

    Worthing

  • York District Hospital

    York

Other trials in United Kingdom

About this study

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

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).

Read the 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.

Keywords
PACIFICO, Follicular Lymphoma, Non-Hodgkin's Lymphoma, Rituximab, R-CVP, R-FC, Older
Medical subject headings
Lymphoma, Follicular, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Mabthera

    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).

  • CyclophosphamideDrug

    Also called Cyclophosphamide monohydrate

    Cyclophosphamide 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)

  • VincristineDrug

    Also called vincristine sulfate

    Vincristine 1.4mg/m2 IV day 1,repeated every 21 days for 8 cycles.

  • PrednisoloneDrug

    Also called Deltacortril

    Prednisolone 40mg/m2 PO day 1-5, repeated every 21 days for 8 cycles.

  • FludarabineDrug

    Also called Fludara

    Fludarabine 40mg/m2 PO day 1-3,repeated every 21 days for 4 cycles

Study groups in NCT01303887
Study groupRoleWhat they receive
R-CVPActive 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).
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisolone
R-FCExperimentalRepeated 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).
Receives: Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 36 months

  2. Progression-free survival

    Measured: 30 months

Secondary outcomes (11)

  1. Response rates (overall, complete and partial) following initial therapy

    Measured: 24 weeks

  2. Response rates following maintenance therapy

    Measured: 30 months

  3. Response duration

    Measured: 30 months

  4. Overall survival

    Measured: End of study

  5. Time to next treatment

    Measured: End of study

  6. Rate of large cell transformation

    Measured: End of study

  7. Response to second-line therapy

    Measured: 30 months

  8. Number of treatment cycles delivered

    Measured: 30 months

  9. Cumulative dose of individual drugs administered

    Measured: 30 months

  10. Quality of life

    Measured: End of study

  11. Cost effectiveness

    Measured: End of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2011 (estimated)
  2. Study startOct 2009
  3. Primary completion11 May 2023
  4. Study completion11 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
680 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01303887
Sponsor's protocol ID
ISRCTN99217456
Other IDs
2008-004759-31, 2008
Acronym
PACIFICO
Status last verified
Apr 2025
First submitted
24 Feb 2011
Last updated
18 Apr 2025
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab, Cyclophosphamide and Vincristine in people with Follicular Lymphoma, run by University of Liverpool at 73 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01303887.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.

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