Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2/Phase 3

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 lymphoma.
    

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 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.

      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.

      This trial follows on from the Phase II randomised study of fludarabine/cyclophosphamide
      combination with or without Rituximab in patients with untreated mantle cell lymphoma. ISRCTN
      number: NCT00053092

      Peer Reviewed and Funded or Endorsed by Cancer Research UK
    

Intervention name(s): rituximab; Cyclophosphamide; Fludarabine
Intervention type(s): Biological; Drug; Drug
Intervention description(s): concentrate for solution for infusion; Tablets; Film coated tablet
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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