Fludarabine, Cyclophosphamide, and Rituximab or Alemtuzumab in Treating CLL2007 CLL 2007 FMP
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in
      different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such as
      rituximab and alemtuzumab, can block cancer growth in different ways. Some find cancer cells
      and help kill them or carry cancer-killing substances to them. Others interfere with the
      ability of cancer cells to grow and spread. It is not yet known whether giving fludarabine
      and cyclophosphamide together with rituximab is more effective than giving fludarabine and
      cyclophosphamide together with alemtuzumab in treating B-cell chronic lymphocytic leukemia.

      PURPOSE: This randomized phase III trial is studying giving fludarabine together with
      cyclophosphamide and rituximab to see how well it works as first-line therapy compared with
      giving fludarabine together with cyclophosphamide and alemtuzumab in treating patients with
      B-cell chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To compare 36-month progression-free survival in patients with Binet stage B or C B-cell
           chronic lymphocytic leukemia treated with first-line therapy comprising fludarabine
           phosphate and cyclophosphamide and either rituximab or alemtuzumab.

      Secondary

        -  To compare the disease-free survival, event-free survival, and overall survival of
           patients treated with these regimens.

        -  To compare time to next treatment in patients treated with these regimens.

        -  To compare the overall response rate (complete response [CR] and partial response [PR])
           in patients treated with these regimens.

        -  To compare the rate of phenotypic and molecular response in patients treated with these
           regimens.

        -  To compare the duration of phenotypic, molecular, complete and partial responses in
           patients treated with these regimens.

        -  To compare the response rates and survival times in biological subgroups.

        -  To compare the rates of treatment-related adverse effects in patients treated with these
           regimens.

        -  To compare the quality of life of patients treated with these regimens.

        -  Minimal residual disease study.

      OUTLINE: This is a multicenter study. Patients are stratified according to Ig mutational
      status and cytogenetic abnormalities. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive rituximab IV on day 1 and fludarabine phosphate and
           cyclophosphamide IV or orally on days 2-4 of course 1. Beginning in course 2 and for all
           subsequent courses, patients receive rituximab IV on day 1 and fludarabine phosphate and
           cyclophosphamide IV or orally on days 1-3.

        -  Arm II: Patients receive alemtuzumab subcutaneously, oral fludarabine phosphate, and
           oral cyclophosphamide on days 1-3.

      In both arms, treatment repeats every 28 days for 6 courses in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 6 months.
    

Intervention name(s): Campath; rituximab; cyclophosphamide; fludarabine
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): Fludarabine-Cyclophosphamide-Campath (FCCam); Fludarabine-Cyclophosphamide-Rituximab (FCR); Fludarabine-Cyclophosphamide-Campath (FCCAM) Fludarabine-Cyclophosphamide-Rituximab (FCR); Fludarabine-Cyclophosphamide-Campath (FCCAM) Fludarabine-Cyclophosphamide-Rituximab (FCR)
Other intervention name(s): Alemtuzumab; Mabthera®; Endoxan®; Fludara®
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine; Alemtuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia