Status:
COMPLETED
Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
Lead Sponsor:
University College, London
Collaborating Sponsors:
Cancer Research UK
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
PHASE3
Brief Summary
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 lym...
Detailed Description
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 dividin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 7 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2015
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT00641095
Start Date
December 7 2006
End Date
May 22 2015
Last Update
October 31 2018
Active Locations (67)
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1
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
2
William Harvey Hospital
Ashford, England, United Kingdom, TN24 0LZ
3
Stoke Mandeville Hospital
Aylesbury, England, United Kingdom, HP21 8AL
4
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA