A Trial Looking at Rituximab and Chemotherapy as a Treatment for Follicular Lymphoma in Elderly Patients
NCT ID: NCT01303887
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
680 participants
INTERVENTIONAL
2009-10-31
2023-05-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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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).
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).
Cyclophosphamide
Cyclophosphamide 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)
Vincristine
Vincristine 1.4mg/m2 IV day 1,repeated every 21 days for 8 cycles.
Prednisolone
Prednisolone 40mg/m2 PO day 1-5, repeated every 21 days for 8 cycles.
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).
Cyclophosphamide
Cyclophosphamide 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)
Fludarabine
Fludarabine 40mg/m2 PO day 1-3,repeated every 21 days for 4 cycles
Interventions
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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).
Cyclophosphamide
Cyclophosphamide 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)
Vincristine
Vincristine 1.4mg/m2 IV day 1,repeated every 21 days for 8 cycles.
Prednisolone
Prednisolone 40mg/m2 PO day 1-5, repeated every 21 days for 8 cycles.
Fludarabine
Fludarabine 40mg/m2 PO day 1-3,repeated every 21 days for 4 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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Liverpool University Hospitals NHS Foundation Trust
OTHER_GOV
Cancer Research UK
OTHER
Roche Pharma AG
INDUSTRY
University of Liverpool
OTHER
Responsible Party
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Principal Investigators
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Andrew Pettitt, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Liverpool and Royal Liverpool and Broadgreen University Hospitals Trust
Locations
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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
Countries
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Related Links
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Other Identifiers
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2008-004759-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISRCTN99217456
Identifier Type: -
Identifier Source: org_study_id
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