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Fludarabine and Cyclophosphamide With or Without Rituximab in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Conditions
Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Mantle-Cell
Conditions: Keywords
contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage I mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Primary Purpose: Treatment
Intervention
Name: rituximab
Type: Biological
Name: cyclophosphamide
Type: Drug
Name: fludarabine phosphate
Type: Drug
Name: fluorescence in situ hybridization
Type: Genetic
Name: immunohistochemistry staining method
Type: Other
Name: immunologic technique
Type: Other
Name: laboratory biomarker analysis
Type: Other
Overall Status
Recruiting
Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating mantle cell lymphoma.
PURPOSE: This randomized phase III trial is comparing how well fludarabine and cyclophosphamide work when given together with or without rituximab in treating patients with previously untreated mantle cell lymphoma.
PURPOSE: This randomized phase III trial is comparing how well fludarabine and cyclophosphamide work when given together with or without rituximab in treating patients with previously untreated mantle cell lymphoma.
Detailed Description
OBJECTIVES:
Primary
- To determine the overall survival in patients with untreated mantle cell lymphoma treated with fludarabine phosphate and cyclophosphamide with vs without rituximab.
Secondary
- To determine the progression-free survival in patients treated with this regimen.
- To determine the toxicity of this regimen in these patients.
- To determine the tumor response in patients treated with this regimen.
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.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Primary
- To determine the overall survival in patients with untreated mantle cell lymphoma treated with fludarabine phosphate and cyclophosphamide with vs without rituximab.
Secondary
- To determine the progression-free survival in patients treated with this regimen.
- To determine the toxicity of this regimen in these patients.
- To determine the tumor response in patients treated with this regimen.
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.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:
- 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
- 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
Locations
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
William Harvey Hospital
Status: Recruiting
Contact: Contact Person - 613-9656-1042
Ashford-Kent, England, United Kingdom
Stoke Mandeville Hospital
Status: Recruiting
Contact: Contact Person - 44-1233-633-331
Aylesbury-Buckinghamshire, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Status: Recruiting
Contact: Contact Person - 44-1296-315-000
Basingstoke, England, United Kingdom
Royal United Hospital
Status: Recruiting
Contact: Contact Person - 44-125-631-4793
Bath, England, United Kingdom
Birmingham Heartlands Hospital
Status: Recruiting
Contact: Contact Person - 44-1-225-824-042
Birmingham, England, United Kingdom
Good Hope Hospital
Status: Recruiting
Contact: Contact Person - 44-121-424-2000
Birmingham, England, United Kingdom
Blackpool Victoria Hospital
Status: Recruiting
Contact: Contact Person - 44-121-424-2000
Blackpool, England, United Kingdom
Addenbrooke's Hospital
Status: Recruiting
Contact: Contact Person - 44-20-7210-4850
Cambridge, England, United Kingdom
Kent and Canterbury Hospital
Status: Recruiting
Contact: Contact Person - 44-1223-245-151
Canterbury, England, United Kingdom
St. Helier Hospital
Status: Recruiting
Contact: Contact Person - 44-1227-766-877
Carshalton, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
Status: Recruiting
Contact: Contact Person - 44-20-8296-2000
Cheltenham, England, United Kingdom
Saint Richards Hospital
Status: Recruiting
Contact: Contact Person - 44-8454-222-222
Chichester, England, United Kingdom
Colchester General Hospital
Status: Recruiting
Contact: Contact Person - 44-1243-788-122
Colchester, England, United Kingdom
Essex County Hospital
Status: Recruiting
Contact: Contact Person - 44-1206-747-474
Colchester, England, United Kingdom
Queen Alexandra Hospital
Status: Recruiting
Contact: Contact Person - 44-1206-853-535
Cosham, England, United Kingdom
Mayday University Hospital
Status: Recruiting
Contact: Contact Person - 44-23-9228-6000
Croydon, England, United Kingdom
Darlington Memorial
Status: Recruiting
Contact: Contact Person - 44-20-8401-3000
Darlington, England, United Kingdom
Darent Valley Hospital
Status: Recruiting
Contact: Contact Person - 44-1325-74-3222
Dartford Kent, England, United Kingdom
Dewsbury and District Hospital
Status: Recruiting
Contact: Contact Person - 44-1322-428-500
Dewsbury, England, United Kingdom
Russells Hall Hospital
Status: Recruiting
Contact: Contact Person - 44-1924-512-000
Dudley, England, United Kingdom
Bishop Auckland Hospital
Status: Recruiting
Contact: Contact Person - 44-1384-456-111
Durham, England, United Kingdom
Epsom General Hospital
Status: Recruiting
Contact: Contact Person - 44-1388-604-040
Epsom, Surrey, England, United Kingdom
Royal Devon and Exeter Hospital
Status: Recruiting
Contact: Contact Person - 44-1372-735-735
Exeter, England, United Kingdom
Queen Elizabeth Hospital
Status: Recruiting
Contact: Contact Person - 44-1392-411-611
Gateshead, England, United Kingdom
Medway Maritime Hospital
Status: Recruiting
Contact: Contact Person - 44-191-482-0000
Gillingham Kent, England, United Kingdom
Gloucestershire Royal Hospital
Status: Recruiting
Contact: Contact Person - 44-1634-830-000
Gloucester, England, United Kingdom
Hereford Hospitals
Status: Recruiting
Contact: Contact Person - 44-8454-222-222
Hereford, England, United Kingdom
Wycombe General Hospital
Status: Recruiting
Contact: Contact Person - 44-1432-355-444
High Wycombe, England, United Kingdom
Cancer Research UK Clinical Centre at St. James's University Hospital
Status: Recruiting
Contact: Contact Person - 44-1494-526-161
Leeds, England, United Kingdom
Leeds General Infirmary
Status: Recruiting
Contact: Contact Person - 44-113-392-4307
Leeds, England, United Kingdom
Saint Bartholomew's Hospital
Status: Recruiting
Contact: Contact Person - 44-113-243-2799
London, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
Status: Recruiting
Contact: Contact Person - 44-20-7601-8391
Maidstone, England, United Kingdom
Christie Hospital
Status: Recruiting
Contact: Contact Person - 44-1622-729-000
Manchester, England, United Kingdom
Manchester Royal Infirmary
Status: Recruiting
Contact: Contact Person - 44-845-226-3000
Manchester, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Status: Recruiting
Contact: Contact Person - 44-161-276-1234
Margate, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Status: Recruiting
Contact: Contact Person - 44-1843-225-544
Newcastle-Upon-Tyne, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Status: Recruiting
Contact: Contact Person - 44-191-232-5131
Northwood, England, United Kingdom
Norfolk and Norwich University Hospital
Status: Recruiting
Contact: Contact Person - 44-1923-826-111
Norwich, England, United Kingdom
Derriford Hospital
Status: Recruiting
Contact: Contact Person - 44-603-286-286
Plymouth, England, United Kingdom
Pontefract General Infirmary
Status: Recruiting
Contact: Simon Rule, MD - 44-1752-517-505
Pontefract West Yorkshire, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
Status: Recruiting
Contact: Contact Person - 44-1977-600-600
Portsmouth Hants, England, United Kingdom
Whiston Hospital
Status: Recruiting
Contact: Contact Person - 44-23-9228-6000
Prescot Merseyside, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
Status: Recruiting
Contact: Contact Person - 44-151-426-1600
Preston, England, United Kingdom
Pembury Hospital
Status: Recruiting
Contact: Contact Person - 44-1772-710-089
Royal Tunbridge Wells, Kent, England, United Kingdom
Salisbury District Hospital
Status: Recruiting
Contact: Contact Person - 44-1892-823-535 ext. 3257
Salisbury, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Status: Recruiting
Contact: Contact Person - 44-1722-336-262
Sheffield, England, United Kingdom
Royal Hallamshire Hospital
Status: Recruiting
Contact: Contact Person - 44-114-226-5000
Sheffield, England, United Kingdom
Royal South Hants Hospital
Status: Recruiting
Contact: Contact Person - 44-114-271-1900
Southampton, England, United Kingdom
Southampton General Hospital
Status: Recruiting
Contact: Contact Person - 44-23-8063-4288
Southampton, England, United Kingdom
Sunderland Royal Hospital
Status: Recruiting
Contact: Contact Person - 44-23-8079-8751
Sunderland, England, United Kingdom
East Surrey Hospital
Status: Recruiting
Contact: Contact Person - 44-191-565-6256
Surrey, England, United Kingdom
Royal Marsden - Surrey
Status: Recruiting
Contact: Contact Person - 44-1737-768-511
Sutton, England, United Kingdom
Great Western Hospital
Status: Recruiting
Contact: Contact Person - 44-20-8642-6011
Swindon, England, United Kingdom
Torbay Hospital
Status: Recruiting
Contact: Contact Person - 44-1793-604-020
Torquay, England, United Kingdom
Royal Cornwall Hospital
Status: Recruiting
Contact: Contact Person - 44-1803-614-567
Truro, Cornwall, England, United Kingdom
Kent and Sussex Hospital
Status: Recruiting
Contact: Contact Person - 44-1872-250-000
Tunbridge Wells, Kent, England, United Kingdom
New Cross Hospital
Status: Recruiting
Contact: Contact Person - 44-1892-26-111
Wolverhampton, England, United Kingdom
Yeovil District Hospital
Status: Recruiting
Contact: Contact Person - 44-190-230-7999
Yeovil, England, United Kingdom
Monklands General Hospital
Status: Recruiting
Contact: Contact Person - 44-1935-475-122
Airdrie, Scotland, United Kingdom
Hairmyres Hospital
Status: Recruiting
Contact: Contact Person - 44-1236-748-748
East Kilbride, Scotland, United Kingdom
Raigmore Hospital
Status: Recruiting
Contact: Contact Person - 44-1355-220-292
Inverness, Scotland, United Kingdom
Pinderfields General Hospital
Status: Recruiting
Contact: Contact Person - 44-1463-704-000 ext. 4310
Wakefield, Scotland, United Kingdom
Wishaw General Hospital
Status: Recruiting
Contact: Contact Person - 44-84-4811-8110
Wishaw, Scotland, United Kingdom
Ysbyty Gwynedd
Status: Recruiting
Contact: Contact Person - 44-169-836-1100
Bangor, Wales, United Kingdom
Amersham Hospital
Status: Recruiting
Contact: Contact Person - 44-1248-370-007
Amersham, United Kingdom
Musgrove Park Hospital
Status: Recruiting
Contact: Contact Person - 44-1494-526-161
Taunton, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1823-333-444
Start Date
December 2006
Sponsors
Derriford Hospital
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page