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PACIFICO   

Title

Purine-Alkylator Combination In Follicular lymphoma Immuno-Chemotherapy for Older patients


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
III Treatment FollowUp Over 60 University of Liverpool and RLBUHT Eudract No: 2008-004759-31

Purpose

Follicular lymphoma (FL) is the most frequently occurring type of indolent non-Hodgkin's lymphoma (NHL) in developed countries. The annual incidence is highest in patients aged 60 or over (1). The disease is usually widespread at presentation and is not curable with currently available treatments. The clinical course is one of recurrent remissions and relapses, the median survival being approximately 10 years from diagnosis

In the UK, R-CVP is approved by NICE for the first-line treatment of FL and is consequently regarded as the standard induction regimen for patients of all ages.

Older patients are almost certainly under-represented in clinical trials of FL owing to a trend for treatment regimens to become ever more intensive and because of the increasing stringency of inclusion criteria. Consequently, there is a lack of data concerning the optimal R-chemotherapy induction regimen in this patient group. The present study aims to remedy this situation by targeting patients with FL aged 60 or over.


Trial Lead Organisations

  • The Royal Liverpool and Broadgreen University Hospital Trust
  • University of Liverpool
  • Chief Investigator: Professor Andrew Pettitt


Trial Start Date

09/09/2009


Trial Coordinator

Michael Stackpoole


Trial Coordinator Email Address

mstack@liverpool.ac.uk


Trial Coordinator Contact No

0151 706 4949


Website Treatment  

To compare R-FC and R-CVP in older patients with symptomatic advanced-stage FL for response rates, progression-free survival (primary end-point), overall survival, toxicity (primary end-point), quality of life and cost effectiveness. Translational studies will also be performed, aiming to identify biomarkers that predict therapeutic response and outcome

This study is a two arm, open-label, multi-centre, parallel group, phase III, randomised controlled trial comparing R-FC and R-CVP in older patients with symptomatic advanced-stage FL for response rates, progression-free survival (primary end-point), overall survival, toxicity (primary end-point), quality of life and cost effectiveness.

Translational studies will also be performed, aiming to identify biomarkers that predict therapeutic response and outcome.

Patients will be randomised equally between the two arms:
  • R-CVP (Rituximab, Cyclophosphamide, Vincristine, Prednisolone)
  • R-FC (Rituximab, Fludarabine, Cyclophosphamide)

Responders will receive 2 years of rituximab maintenance. All patients will be followed up for at least 3 years.

Trial Endpoints  


Primary Outcome  

  • Progression free survival
  • Toxicity


Secondary Outcomes  

  • Response rates (overall, complete and partial) following initial therapy
  • Response rates following maintenance therapy
  • Overall survival
  • Number of treatment cycles delivered
  • Cumulative dose of individual drugs administered
  • Quality of life (EORTC QLQ-30 (v3) and EQ-5D)
  • Cost effectiveness
  • Response to second-line therapy

Eligibility  

Main Criteria for Inclusion:
  • 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 x109/L
    • Platelet count ≥ 100 x 109/L

Main criteria For Exclusion:

  • 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 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

UK: ENGLAND

  • Aylesbury, Stoke Mandeville Hospital (Aylesbury) (Beena Pushkaran)
  • Barnstaple, North Devon District Hospital (Barnstaple) (Anthony Todd)
  • Bath, Royal United Hospital (Bath) (Christopher Knechtli)
  • Birmingham, Heartlands Hospital (Birmingham) (Shankara Paneesha)
  • Birmingham, Sandwell Hospital (Birmingham) (Yasmin Hasan)
  • Blackpool, Blackpool Victoria Hospital (Marian Macheta)
  • Bournemouth, The Royal Bournemouth Hospital (Helen McCarthy)
  • Bradford, Bradford Royal Infirmary (Adrian Williams)
  • Bradford, Bradford Royal Infirmary (Lisa Newton)
  • Brighton, Royal Sussex County Hospital (Brighton) (Andrew Webb)
  • Bristol, Frenchay Hospital (Bristol) (Sophie Otton)
  • Bromley, Princess Royal Hospital (Bromley) (Mansour (Muhammed) Ceesay)
  • Burton-upon-Trent, Queen's Hospital (Burton-upon-Trent) (Humayun Ahmad)
  • Bury St. Edmunds, West Suffolk Hospital (Bury St. Edmunds) (Mamatha Karanth)
  • Cambridge, Addenbrooke's Hospital (Cambridge) (George Follows)
  • Canterbury, Kent and Canterbury Hospital (Christopher Pocock)
  • Cheltenham, Cheltenham General Hospital (Kim Benstead)
  • Chester, Countess of Chester Hospital (Salaheddin Tueger)
  • Chichester, St. Richard's Hospital (Chichester) (Santosh Narat)
  • Coventry, University Hospitals Coventry (Beth Harrison)
  • Crewe, Leighton Hospital (Crewe) (Kamaraj Karunanithi)
  • Derby, Royal Derby Hospital (Adrian Smith)
  • Dudley, Russells Hall Hospital (Dudley) (Savio Fernandes)
  • Enfield, Barnet General Hospital (Enfield) (Andres Virchis)
  • Exeter, Royal Devon & Exeter Hospital (Anthony Todd)
  • Gateshead, Queen Elizabeth Hospital (Gateshead) (Scott Marshall)
  • Gloucester, Gloucestershire Royal Hospital (Gloucester) (Kim Benstead)
  • Grimsby, Diana Princess of Wales Hospital (Susan Levison-Keating)
  • Harrow, Northwick Park Hospital (Harrow) (Charalampia Kyriakou)
  • Hastings, Conquest Hospital (Sunil Gupta)
  • Hemel Hempstead, Hemel Hempstead General (Justin Harrison)
  • Huddersfield, Huddersfield Royal Infirmary (Sylvia Feyler)
  • Huntingdon, Hinchingbrooke Hospital (Huntingdon) (Sateesh Nagumantry)
  • Ipswich, Ipswich Hospital (Jamie Morgan)
  • Keighley, Airedale General Hospital (Keighley) (Chetan Patalappa)
  • Kettering, Kettering General Hospital (Jag Gandla)
  • King's Lynn, Queen Elizabeth Hospital (King's Lynn) (Lisa Cooke)
  • Kingston Upon Hull, Castle Hill Hospital (Cottingham) (Russell Patmore)
  • Leeds, St. James's University Hospital (Leeds) (Rod Johnson)
  • Leicester, Leicester Royal Infirmary (Ben Kennedy)
  • Liverpool, Royal Liverpool University Hospital (Andrew Pettitt)
  • Liverpool, University Hospital Aintree (Jeffrey Smith)
  • London, Guy's & St Thomas' Hospital (London) (Paul Fields)
  • London, Queen Elizabeth Hospital (Woolwich) (Betty Cheung)
  • London, Royal Free Hospital (London) (Christopher McNamara)
  • London, St. Bartholomew's Hospital (London) (Silvia Montoto)
  • London, St. Mary's Hospital (London) (Sasha Marks)
  • London, University College Hospital (London) (Kirit Ardeshna)
  • Luton, Luton & Dunstable Hospital (Peter Hoskin)
  • Maidstone, Kent Oncology Centre (Maidstone) (Saad Rassam)
  • Manchester, The Christie (Manchester) (John Radford)
  • Manchester, Trafford General Hospital (Manchester) (Patrick Carrington)
  • Middlesbrough, James Cook University Hospital (Middlesbrough) (Raymond Dang)
  • Newcastle upon Tyne, Royal Victoria Infirmary (Newcastle) (Anne Lennard)
  • Northampton, Northampton General Hospital (Angela Bowen)
  • Northwood, Mount Vernon Hospital (Northwood) (Jonathan Lambert)
  • Nottingham, Nottingham City Hospital (Andrew McMillan)
  • Nuneaton, George Eliot Hospital (Nuneaton) (Mekkali Narayanan)
  • Peterborough, Peterborough District Hospital (Sateesh Nagumantry)
  • Plymouth, Derriford Hospital (Plymouth) (Simon Rule)
  • Poole, Poole Hospital (Fergus Jack)
  • Prescot, Whiston Hospital (Liverpool) (Toby Nicholson)
  • Romford, Queen's Hospital (Romford) (Paul Greaves)
  • Salford, Salford Royal Hospital (Simon Jowitt)
  • Salisbury, Salisbury District Hospital (Jonathan Cullis)
  • Sheffield, Royal Hallamshire Hospital (Sheffield) (Josh Wright)
  • Shrewsbury, Royal Shrewsbury Hospital (Stephen John McKew)
  • South Shields, South Tyneside District General Hospital (South Shields) (Simon Lyons)
  • Southall, Ealing Hospital (Southall) (Taku Sugai)
  • Southampton, Southampton General Hospital (Peter Johnson)
  • Stafford, Stafford District General Hospital (Ghulam Kakepoto)
  • Stevenage, Lister Hospital (Stevenage) (Judith Hanslip)
  • Sunderland, Sunderland Royal Hospital (Shikha Chatree)
  • Sutton, Royal Marsden Hospital (Sutton) (David Cunningham)
  • Swindon, The Great Western Hospital (Swindon) (Norbert Blesing)
  • Torquay, Torbay District General Hospital (Torquay) (Deborah Turner)
  • Truro, Royal Cornwall Hospital (Truro) (Bryson Pottinger)
  • Uxbridge, Hillingdon Hospital (Uxbridge) (Richard Kaczmarski)
  • Wakefield, Pinderfields General Hospital (Wakefield) (Paul Moreton)
  • Warrington, Warrington Hospital (Mohamed Kaleel Rahman)
  • Westcliff-on-Sea, Southend Hospital (Westcliff-on-Sea) (Paul Cervi)
  • Weston-super-Mare, Weston General Hospital (Weston-super-Mare) (Lisa Wolger)
  • Winchester, Royal Hampshire County Hospital (Winchester) (Katharine Lowndes)
  • Wirral, Arrowe Park Hospital (Wirral) (Ranjit Dasgupta)
  • Worcester, Worcestershire Acute Hospitals NHS Trust (Salim Shafeek)
  • Worthing, Worthing Hospital (Santosh Narat)

UK: N. IRELAND

  • Belfast, Belfast City Hospital (Paul Kettle)
  • Londonderry, Altnagelvin Hospital (Londonderry) (Feargal McNicholl)

UK: SCOTLAND

  • Aberdeen, Aberdeen Royal Infirmary (Dominic Culligan)
  • Edinburgh, Western General Hospital (Edinburgh) (Fiona Scott)
  • Falkirk, Falkirk & District Royal Infirmary (Roddy Neilson)
  • Glasgow, The Beatson West of Scotland Cancer Centre (Glasgow) (Pam McKay)
  • Inverness, Raigmore Hospital (Inverness) (Peter Forsyth)

UK: WALES

  • Abergavenny, Nevill Hall Hospital (Abergavenny) (Nilima Parry-Jones)
  • Bangor, Ysbyty Gwynedd (Bangor) (David Edwards)
  • Cardiff, University Hospital of Wales (Clare Rowntree)
  • Cardiff, Velindre Hospital (Cardiff) (Eve Gallop-Evans)
  • Newport, Royal Gwent Hospital (Newport) (Helen Jackson)
  • Rhyl, Glan Clwyd Hospital (Rhyl) (Earnest Heartin)

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