Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
- To determine the overall survival in patients with untreated mantle cell lymphoma
treated with fludarabine phosphate and cyclophosphamide with vs without rituximab.
- 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
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
Allocation: Randomized, Primary Purpose: Treatment
Simon Rule, MD