Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
NCT ID: NCT00641095
Last Updated: 2018-10-31
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
370 participants
INTERVENTIONAL
2006-12-07
2015-05-22
Brief Summary
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Detailed Description
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OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive fludarabine phosphate IV or orally once daily and oral cyclophosphamide once daily on days 1-3. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive rituximab IV on day 1 and fludarabine phosphate IV or orally once daily and oral cyclophosphamide once daily on days 1-3. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo bone marrow and blood sample collection periodically for molecular studies. Samples are analyzed for morphology; sIgM, sIgD, CD19, CD20, CD5, CD10, CD23, bcl-1, bcl-6 via immunophenotyping and immunohistochemistry; and t(11,14) translocation via interphase fluorescence in situ hybridization (FISH) mutational analysis.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
This trial follows on from the Phase II randomised study of fludarabine/cyclophosphamide combination with or without Rituximab in patients with untreated mantle cell lymphoma. ISRCTN number: NCT00053092
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fludarabine/Cyclophosphamide/Rituximab
Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3 Rituximab 375mgs/m2 day 1 iv infusion
Every 28 days
rituximab
concentrate for solution for infusion
Cyclophosphamide
Tablets
Fludarabine
Film coated tablet
Fludarabine/Cyclophosphamide
Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3
Every 28 days
Cyclophosphamide
Tablets
Fludarabine
Film coated tablet
Interventions
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rituximab
concentrate for solution for infusion
Cyclophosphamide
Tablets
Fludarabine
Film coated tablet
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed mantle cell lymphoma (MCL), meeting the following criteria:
* Diagnosis confirmed by examination of representative material (lymph nodes or bone marrow) together with a typical immunophenotype CD5+, CD23-, sIgM, cyclin D1 nuclear positivity is desirable but not essential
* Central review of histology will be performed on diagnostic material
* Molecular or cytogenetic confirmation of diagnosis is not required
* Previously untreated disease at any stage requiring therapy in the opinion of the treating physician
PATIENT CHARACTERISTICS:
* Life expectancy ≥ 3 months
* Life expectancy not severely limited by other illness
* Creatinine clearance ≥ 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during study therapy
* No known serological positivity for HBV, HCV, or HIV
* No concurrent uncontrolled serious medical conditions
* No severe impairment of renal or liver function (alkaline phosphatase, bilirubin or creatinine \> 2.5 times upper limit of normal) not related to lymphoma
* No known hypersensitivity to murine proteins
* No prior malignancy in the past 5 years, except for nonmelanoma skin tumor or curatively resected carcinoma in situ of the uterine cervix
* No history of a psychological illness or condition that, in the opinion of the investigator, may adversely affect compliance with study medication
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy
18 Years
120 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
University College, London
OTHER
Responsible Party
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Principal Investigators
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Simon Rule, MD
Role: PRINCIPAL_INVESTIGATOR
Derriford Hospital
Locations
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Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
William Harvey Hospital
Ashford, England, United Kingdom
Stoke Mandeville Hospital
Aylesbury, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Royal United Hospital
Bath, England, United Kingdom
Good Hope Hospital
Birmingham, England, United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Blackpool Victoria Hospital
Blackpool, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
St. Helier Hospital
Carshalton, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Saint Richards Hospital
Chichester, England, United Kingdom
Essex County Hospital
Colchester, England, United Kingdom
Colchester General Hospital
Colchester, England, United Kingdom
Queen Alexandra Hospital
Cosham, England, United Kingdom
Mayday University Hospital
Croydon, England, United Kingdom
Darlington Memorial
Darlington, England, United Kingdom
Darent Valley Hospital
Dartford, England, United Kingdom
Dewsbury and District Hospital
Dewsbury, England, United Kingdom
Russells Hall Hospital
Dudley, England, United Kingdom
Bishop Auckland Hospital
Durham, England, United Kingdom
Epsom General Hospital
Epsom, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Queen Elizabeth Hospital
Gateshead, England, United Kingdom
Medway Maritime Hospital
Gillingham, England, United Kingdom
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom
Hereford Hospitals
Hereford, England, United Kingdom
Wycombe General Hospital
High Wycombe, England, United Kingdom
Leeds General Infirmary
Leeds, England, United Kingdom
Cancer Research UK Clinical Centre at St. James's University Hospital
Leeds, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom
Manchester Royal Infirmary
Manchester, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Pontefract General Infirmary
Pontefract, England, United Kingdom
Portsmouth Oncology Centre at St Mary's Hospital
Portsmouth, England, United Kingdom
Whiston Hospital
Prescot, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom
East Surrey Hospital
Redhill, England, United Kingdom
Pembury Hospital
Royal Tunbridge Wells, England, United Kingdom
Kent and Sussex Hospital
Royal Tunbridge Wells, England, United Kingdom
Salisbury District Hospital
Salisbury, England, United Kingdom
Royal Hallamshire Hospital
Sheffield, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Royal South Hants Hospital
Southampton, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Sunderland Royal Hospital
Sunderland, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Great Western Hospital
Swindon, England, United Kingdom
Torbay Hospital
Torquay, England, United Kingdom
Royal Cornwall Hospital
Truro, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Yeovil District Hospital
Yeovil, England, United Kingdom
Monklands General Hospital
Airdrie, Scotland, United Kingdom
Hairmyres Hospital
East Kilbride, Scotland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Pinderfields General Hospital
Wakefield, Scotland, United Kingdom
Wishaw General Hospital
Wishaw, Scotland, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, United Kingdom
Amersham Hospital
Amersham, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Countries
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References
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Rule S, Smith P, Johnson PW, Bolam S, Follows G, Gambell J, Hillmen P, Jack A, Johnson S, Kirkwood AA, Kruger A, Pocock C, Seymour JF, Toncheva M, Walewski J, Linch D. The addition of rituximab to fludarabine and cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma: results of a randomized UK National Cancer Research Institute trial. Haematologica. 2016 Feb;101(2):235-40. doi: 10.3324/haematol.2015.128710. Epub 2015 Nov 26.
Related Links
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Abstract on Pubmed
Publication in haematologica
Other Identifiers
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2006-001965-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MREC-02/6/31
Identifier Type: OTHER
Identifier Source: secondary_id
ISRCTN
Identifier Type: REGISTRY
Identifier Source: secondary_id
UCL/06/052
Identifier Type: -
Identifier Source: org_study_id
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