Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
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
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Simon Rule, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Derriford Hospital
Authority:
Unspecified
Study ID:
CDR0000589227
NCT ID:
NCT00641095
Start Date:
December 2006
Completion Date:
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Lymphoma, Mantle-Cell
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