Cyclophosphamide and Total Body Irradiation in Treating Patients Who Are Undergoing an Autologous Peripheral Stem Cell Transplant For Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of
      cancer cells by stopping them from dividing or killing them. Giving colony-stimulating
      factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone
      marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is
      then given to prepare the bone marrow for the stem cell transplant. The stem cells are then
      returned to the patient to replace the blood-forming cells that were destroyed by the
      chemotherapy and radiation therapy.

      PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with
      total-body irradiation works in treating patients who are undergoing an peripheral stem cell
      transplant for chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety and feasibility of autologous peripheral blood stem cell
           transplantation in patients with chronic lymphocytic leukemia treated with
           cyclophosphamide and total-body irradiation.

      Secondary

        -  Determine the safety, feasibility, and efficacy of combination therapy comprising
           dexamethasone, carmustine, cytarabine, etoposide, and melphalan (Dexa-BEAM) and
           filgrastim (G-CSF) mobilization in patients treated with this regimen.

        -  Determine the efficacy of ex-vivo graft purging in patients treated with this regimen.

        -  Determine the incidence of complete clinical and molecular remissions in patients
           treated with this regimen.

        -  Determine the progression-free survival of patients treated with this regimen.

      OUTLINE: This is a multicenter, open-label, nonrandomized study.

        -  Cytoreductive treatment: Patients undergo 2-4 courses of cytoreductive treatment,
           preferably following the fludarabine and cyclophosphamide (FC) protocol.

        -  Stem cell mobilization: Patients achieving a complete remission (CR) or partial
           remission (PR) and stable blood counts undergo stem cell mobilization comprising
           dexamethasone, carmustine, cytarabine, etoposide, melphalan (Dexa-BEAM), and filgrastim
           (G-CSF). Patients with an adequate number of mobilized cells undergo stem cell
           collection. Patients with CR or very good PR proceed to myeloablative therapy.

        -  Myeloablative therapy: Patients undergo total-body irradiation on day -4 and receive
           cyclophosphamide IV on days -4 and -3.

        -  Autologous peripheral blood stem cell transplantation (PBSCT): Patients undergo
           autologous PBSCT on day 0.

      After completion of study, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
    

Intervention name(s): filgrastim; carmustine; cyclophosphamide; cytarabine; dexamethasone; etoposide; fludarabine phosphate; melphalan; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Cytarabine; Dexamethasone; Cyclophosphamide; Melphalan; Carmustine; Fludarabine; Fludarabine phosphate; Etoposide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage 0 chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; refractory chronic lymphocytic leukemia