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.
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
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
Locations
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Status: Recruiting
Contact: Contact Person - 613-9656-1042
William Harvey Hospital
Ashford-Kent, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1233-633-331
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1296-315-000
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-125-631-4793
Royal United Hospital
Bath, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1-225-824-042
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-121-424-2000
Good Hope Hospital
Birmingham, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-121-424-2000
Blackpool Victoria Hospital
Blackpool, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-20-7210-4850
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1223-245-151
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1227-766-877
St. Helier Hospital
Carshalton, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-20-8296-2000
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-8454-222-222
Saint Richards Hospital
Chichester, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1243-788-122
Colchester General Hospital
Colchester, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1206-747-474
Essex County Hospital
Colchester, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1206-853-535
Queen Alexandra Hospital
Cosham, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-23-9228-6000
Mayday University Hospital
Croydon, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-20-8401-3000
Darlington Memorial
Darlington, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1325-74-3222
Darent Valley Hospital
Dartford Kent, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1322-428-500
Dewsbury and District Hospital
Dewsbury, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1924-512-000
Russells Hall Hospital
Dudley, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1384-456-111
Bishop Auckland Hospital
Durham, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1388-604-040
Epsom General Hospital
Epsom, Surrey, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1372-735-735
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1392-411-611
Queen Elizabeth Hospital
Gateshead, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-191-482-0000
Medway Maritime Hospital
Gillingham Kent, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1634-830-000
Gloucestershire Royal Hospital
Gloucester, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-8454-222-222
Hereford Hospitals
Hereford, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1432-355-444
Wycombe General Hospital
High Wycombe, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1494-526-161
Cancer Research UK Clinical Centre at St. James's University Hospital
Leeds, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-113-392-4307
Leeds General Infirmary
Leeds, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-113-243-2799
Saint Bartholomew's Hospital
London, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-20-7601-8391
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1622-729-000
Christie Hospital
Manchester, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-845-226-3000
Manchester Royal Infirmary
Manchester, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-161-276-1234
Queen Elizabeth The Queen Mother Hospital
Margate, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1843-225-544
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle-Upon-Tyne, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-191-232-5131
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1923-826-111
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-603-286-286
Derriford Hospital
Plymouth, England, United Kingdom
Status: Recruiting
Contact: Simon Rule, MD - 44-1752-517-505
Pontefract General Infirmary
Pontefract West Yorkshire, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1977-600-600
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-23-9228-6000
Whiston Hospital
Prescot Merseyside, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-151-426-1600
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1772-710-089
Pembury Hospital
Royal Tunbridge Wells, Kent, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1892-823-535 ext. 3257
Salisbury District Hospital
Salisbury, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1722-336-262
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-114-226-5000
Royal Hallamshire Hospital
Sheffield, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-114-271-1900
Royal South Hants Hospital
Southampton, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-23-8063-4288
Southampton General Hospital
Southampton, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-23-8079-8751
Sunderland Royal Hospital
Sunderland, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-191-565-6256
East Surrey Hospital
Surrey, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1737-768-511
Royal Marsden - Surrey
Sutton, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-20-8642-6011
Great Western Hospital
Swindon, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1793-604-020
Torbay Hospital
Torquay, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1803-614-567
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1872-250-000
Kent and Sussex Hospital
Tunbridge Wells, Kent, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1892-26-111
New Cross Hospital
Wolverhampton, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-190-230-7999
Yeovil District Hospital
Yeovil, England, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1935-475-122
Monklands General Hospital
Airdrie, Scotland, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1236-748-748
Hairmyres Hospital
East Kilbride, Scotland, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1355-220-292
Raigmore Hospital
Inverness, Scotland, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1463-704-000 ext. 4310
Pinderfields General Hospital
Wakefield, Scotland, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-84-4811-8110
Wishaw General Hospital
Wishaw, Scotland, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-169-836-1100
Ysbyty Gwynedd
Bangor, Wales, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1248-370-007
Amersham Hospital
Amersham, United Kingdom
Status: Recruiting
Contact: Contact Person - 44-1494-526-161
Musgrove Park Hospital
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