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

April 16, 2025 updated by: University of Liverpool

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
680

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom
        • Aberdeen Royal Infirmary
      • Bangor, United Kingdom
        • Ysbyty Gwynedd
      • Birmingham, United Kingdom
        • Birmingham Heartlands
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Bristol, United Kingdom
        • Frenchay Hospital
      • Burton-upon-Trent, United Kingdom
        • Queen's Hospital, Burton
      • Cambridge, United Kingdom
        • Addenbrookes Hospital
      • Canterbury, United Kingdom
        • Kent and Canterbury Hospital
      • Cardiff, United Kingdom
        • Velindre Hospital
      • Chester, United Kingdom
        • Countess of Chester
      • Crewe, United Kingdom
        • Leighton Hospital
      • Davyhulme, United Kingdom
        • Trafford General Hospital
      • Dudley, United Kingdom
        • Russels Hall Hospital
      • Exeter, United Kingdom
        • Royal Devon & Exeter Hospital
      • Falkirk, United Kingdom
        • Falkirk & District Royal Infirmary
      • Gateshead, United Kingdom
        • Queen Elizabeth Hospital
      • Gillingham, United Kingdom
        • Medway Maritime Hospital
      • Glasgow, United Kingdom
        • Beatson Oncology Centre
      • Glasgow, United Kingdom
        • Royal Alexandra Hospital
      • Harrogate, United Kingdom
        • Harrogate District Foundation Trust
      • Harrow, United Kingdom
        • Northwick Park Hospital
      • Hayes, United Kingdom
        • Princess Royal Hospital, Bromley
      • Huddersfield, United Kingdom
        • Huddersfield Royal Infirmary
      • Hull, United Kingdom
        • Castle Hill Hospital
      • Inverness, United Kingdom
        • Raigmore Hospital,
      • Ipswich, United Kingdom
        • Ipswich Hospital
      • Kettering, United Kingdom
        • Kettering General Hospital
      • Kings Lynn, United Kingdom
        • The Queen Elizabeth Hospital, Kings Lynn
      • Leeds, United Kingdom
        • St James University Hospital
      • Leicester, United Kingdom
        • Leicester Royal Infirmary
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital
      • Liverpool, United Kingdom
        • University Hospital Aintree
      • London, United Kingdom
        • Kings College Hospital
      • London, United Kingdom
        • Royal Free Hospital
      • London, United Kingdom
        • University College Hospital
      • London, United Kingdom
        • Guys & St Thomas Hospital
      • London, United Kingdom
        • St Bartholomews Hospital
      • Londonderry, United Kingdom
        • Altnagelvin Hospital
      • Luton, United Kingdom
        • Luton & Dunstable Hospital
      • Maidstone, United Kingdom
        • Kent Oncology Centre
      • Manchester, United Kingdom
        • Manchester Royal Infirmary
      • Manchester, United Kingdom
        • The Christie Hospital
      • Newcastle upon Tyne, United Kingdom
        • Royal Victoria Infirmary
      • Northampton, United Kingdom
        • Northampton General Hospital
      • Northwood, United Kingdom
        • Mount Vernon Hospital
      • Nottingham, United Kingdom
        • Nottingham City Hospital
      • Plymouth, United Kingdom
        • Derriford Hospital
      • Prescot, United Kingdom
        • Whiston Hospital
      • Romford, United Kingdom
        • Queens Hospital
      • Salford, United Kingdom
        • Salford Royal Hospital
      • Salisbury, United Kingdom
        • Salisbury District Hospital
      • Scunthorpe, United Kingdom
        • Diana Princess of Wales Hospital
      • Sheffield, United Kingdom
        • Royal Hallamshire Hospital
      • Slough, United Kingdom
        • Wexham Park Hospital
      • South Shields, United Kingdom
        • South Tyneside District General Hospital
      • Southampton, United Kingdom
        • Southampton General Hospital
      • Southampton, United Kingdom
        • Basingstoke and North Hampshire Hospital
      • Southampton, United Kingdom
        • St Richards Hospital
      • St Asaph, United Kingdom
        • Glan Clwyd Hospital
      • Stafford, United Kingdom
        • Stafford District General Hospital
      • Stevenage, United Kingdom
        • Lister Hospital
      • Sunderland, United Kingdom
        • Sunderland Royal Hospital
      • Swindon, United Kingdom
        • Great Western Hospital
      • Torquay, United Kingdom
        • Torbay District General Hospital
      • Truro, United Kingdom
        • Royal Cornwall Hospital
      • Uxbridge, United Kingdom
        • Hillingdon Hospital
      • Wakefield, United Kingdom
        • Pinderfields General Hospital
      • Watford, United Kingdom
        • West Herts
      • Wirral, United Kingdom
        • Arrowe Park Hospital
      • Worcester, United Kingdom
        • Worcestershire Acute Hospitals NHS Trust
      • Worthing, United Kingdom
        • Worthing Hospital
      • York, United Kingdom
        • York District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 × 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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).
Other Names:
  • Mabthera
Drug: Cyclophosphamide
Cyclophosphamide 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)
Other Names:
  • Cyclophosphamide monohydrate
Drug: Vincristine
Vincristine 1.4mg/m2 IV day 1,repeated every 21 days for 8 cycles.
Other Names:
  • vincristine sulfate
Drug: Prednisolone
Prednisolone 40mg/m2 PO day 1-5, repeated every 21 days for 8 cycles.
Other Names:
  • Deltacortril
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).
Drug: Cyclophosphamide
Cyclophosphamide 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)
Other Names:
  • Cyclophosphamide monohydrate
Drug: Fludarabine
Fludarabine 40mg/m2 PO day 1-3,repeated every 21 days for 4 cycles
Other Names:
  • Fludara

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 30 months
30 months
Toxicity
Time Frame: 36 months
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival
Time Frame: End of study
End of study
Response rates (overall, complete and partial) following initial therapy
Time Frame: 24 weeks
24 weeks
Response rates following maintenance therapy
Time Frame: 30 months
30 months
Response duration
Time Frame: 30 months
30 months
Time to next treatment
Time Frame: End of study
End of study
Rate of large cell transformation
Time Frame: End of study
End of study
Response to second-line therapy
Time Frame: 30 months
30 months
Number of treatment cycles delivered
Time Frame: 30 months
30 months
Cumulative dose of individual drugs administered
Time Frame: 30 months
30 months
Quality of life
Time Frame: End of study
End of study
Cost effectiveness
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Liverpool

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG
Cancer Research UK
Liverpool University Hospitals NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Pettitt, Professor, University of Liverpool and Royal Liverpool and Broadgreen University Hospitals Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ISRCTN99217456
  • 2008-004759-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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