A Trial Looking at Rituximab and Chemotherapy as a Treatment for Follicular Lymphoma in Elderly Patients
Conditions
Follicular Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Conditions: Keywords
PACIFICO, Follicular Lymphoma, Non-Hodgkin's Lymphoma, Rituximab, R-CVP, R-FC, Older
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Rituximab Type: Drug
Name: Cyclophosphamide Type: Drug
Name: Vincristine Type: Drug
Name: Prednisolone Type: Drug
Name: Fludarabine Type: Drug
Overall Status
Recruiting
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).
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 60 Years
Gender: Both
Criteria: 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
Locations
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Status: Recruiting
Ysbyty Gwynedd
Bangor, United Kingdom
Status: Recruiting
Birmingham Heartlands
Birmingham, United Kingdom
Status: Recruiting
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Status: Recruiting
Bradford Royal Infirmary
Bradford, United Kingdom
Status: Recruiting
Frenchay Hospital
Bristol, United Kingdom
Status: Recruiting
Queen's Hospital, Burton
Burton-upon-Trent, United Kingdom
Status: Recruiting
Addenbrookes Hospital
Cambridge, United Kingdom
Status: Recruiting
Kent and Canterbury Hospital
Canterbury, United Kingdom
Status: Recruiting
Velindre Hospital
Cardiff, United Kingdom
Status: Recruiting
Countess of Chester
Chester, United Kingdom
Status: Recruiting
Leighton Hospital
Crewe, United Kingdom
Status: Recruiting
Trafford General Hospital
Davyhulme, United Kingdom
Status: Recruiting
Russels Hall Hospital
Dudley, United Kingdom
Status: Recruiting
Royal Devon & Exeter Hospital
Exeter, United Kingdom
Status: Recruiting
Falkirk & District Royal Infirmary
Falkirk, United Kingdom
Status: Recruiting
Queen Elizabeth Hospital
Gateshead, United Kingdom
Status: Recruiting
Medway Maritime Hospital
Gillingham, United Kingdom
Status: Recruiting
Beatson Oncology Centre
Glasgow, United Kingdom
Status: Recruiting
Royal Alexandra Hospital
Glasgow, United Kingdom
Status: Recruiting
Harrogate District Foundation Trust
Harrogate, United Kingdom
Status: Recruiting
Northwick Park Hospital
Harrow, United Kingdom
Status: Recruiting
Princess Royal Hospital, Bromley
Hayes, United Kingdom
Status: Recruiting
Huddersfield Royal Infirmary
Huddersfield, United Kingdom
Status: Recruiting
Castle Hill Hospital
Hull, United Kingdom
Status: Recruiting
Raigmore Hospital,
Inverness, United Kingdom
Status: Recruiting
Ipswich Hospital
Ipswich, United Kingdom
Status: Recruiting
Kettering General Hospital
Kettering, United Kingdom
Status: Recruiting
The Queen Elizabeth Hospital, Kings Lynn
Kings Lynn, United Kingdom
Status: Recruiting
St James University Hospital
Leeds, United Kingdom
Status: Recruiting
Leicester Royal Infirmary
Leicester, United Kingdom
Status: Recruiting
Royal Liverpool University Hospital
Liverpool, United Kingdom
Status: Recruiting
University Hospital Aintree
Liverpool, United Kingdom
Status: Recruiting
Altnagelvin Hospital
Londonderry, United Kingdom
Status: Recruiting
Guys & St Thomas Hospital
London, United Kingdom
Status: Recruiting
Kings College Hospital
London, United Kingdom
Status: Recruiting
Royal Free Hospital
London, United Kingdom
Status: Recruiting
St Bartholomews Hospital
London, United Kingdom
Status: Recruiting
University College Hospital
London, United Kingdom
Status: Recruiting
Luton & Dunstable Hospital
Luton, United Kingdom
Status: Recruiting
Kent Oncology Centre
Maidstone, United Kingdom
Status: Recruiting
Manchester Royal Infirmary
Manchester, United Kingdom
Status: Recruiting
The Christie Hospital
Manchester, United Kingdom
Status: Recruiting
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Status: Recruiting
Northampton General Hospital
Northampton, United Kingdom
Status: Recruiting
Mount Vernon Hospital
Northwood, United Kingdom
Status: Recruiting
Nottingham City Hospital
Nottingham, United Kingdom
Status: Recruiting
Derriford Hospital
Plymouth, United Kingdom
Status: Recruiting
Whiston Hospital
Prescot, United Kingdom
Status: Recruiting
Queens Hospital
Romford, United Kingdom
Status: Recruiting
Salford Royal Hospital
Salford, United Kingdom
Status: Recruiting
Salisbury District Hospital
Salisbury, United Kingdom
Status: Recruiting
Diana Princess of Wales Hospital
Scunthorpe, United Kingdom
Status: Recruiting
Royal Hallamshire Hospital
Sheffield, United Kingdom
Status: Recruiting
Wexham Park Hospital
Slough, United Kingdom
Status: Recruiting
South Tyneside District General Hospital
South Shields, United Kingdom
Status: Recruiting
Basingstoke and North Hampshire Hospital
Southampton, United Kingdom
Status: Recruiting
Southampton General Hospital
Southampton, United Kingdom
Status: Recruiting
St Richards Hospital
Southampton, United Kingdom
Status: Recruiting
Glan Clwyd Hospital
St Asaph, United Kingdom
Status: Recruiting
Stafford District General Hospital
Stafford, United Kingdom
Status: Recruiting
Lister Hospital
Stevenage, United Kingdom
Status: Recruiting
Sunderland Royal Hospital
Sunderland, United Kingdom
Status: Recruiting
Great Western Hospital
Swindon, United Kingdom
Status: Recruiting
Torbay District General Hospital
Torquay, United Kingdom
Status: Recruiting
Royal Cornwall Hospital
Truro, United Kingdom
Status: Recruiting
Hillingdon Hospital
Uxbridge, United Kingdom
Status: Recruiting
Pinderfields General Hospital
Wakefield, United Kingdom
Status: Recruiting
West Herts
Watford, United Kingdom
Status: Recruiting
Arrowe Park Hospital
Wirral, United Kingdom
Status: Recruiting
Worcestershire Acute Hospitals NHS Trust
Worcester, United Kingdom
Status: Recruiting
Worthing Hospital
Worthing, United Kingdom
Status: Recruiting
York District Hospital
York, United Kingdom
Status: Recruiting
Start Date
October 2009
Completion Date
September 2016
Sponsors
University of Liverpool
Source
University of Liverpool
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page