Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With CLL
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cladribine, use different ways to stop cancer
      cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab,
      can locate cancer cells and either kill them or deliver cancer-killing substances to them
      without harming normal cells. Combining cladribine with rituximab may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving cladribine and rituximab as
      remission induction therapy together with rituximab and stem cell mobilization in treating
      patients with chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy and tolerability of cladribine and rituximab as remission
           induction therapy in patients with chronic lymphocytic leukemia.

        -  Determine the complete remission rate in patients treated with this regimen.

      Secondary

        -  Determine the very good partial remission rate and nodular partial remission rate in
           patients treated with this regimen.

        -  Determine the toxicity of this regimen, in terms of hemotoxicity and infection rate, in
           these patients.

        -  Determine the efficacy of in vivo purging with rituximab measured by immunophenotyping
           in these patients.

        -  Determine the feasibility of stem cell harvest in these patients after treatment with
           this induction therapy regimen and in vivo purging with rituximab.

      OUTLINE: This is a multicenter study.

        -  Remission induction: Patients receive cladribine subcutaneously (SC) on days 1-5. During
           courses 2-4, patients also receive rituximab IV on day 1. Treatment repeats every 28
           days for up to 4 courses in the absence of unacceptable toxicity. If unacceptable
           toxicity persists, patients receive rituximab alone.

      Patients not achieving a complete remission (CR), very good partial remission (VGPR), or
      nodular partial remission (NPR) receive CHOP chemotherapy comprising cyclophosphamide IV,
      doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment
      repeats every 21 days for up to 4 courses or until patients achieve a CR, VGPR, or NPR.

      Patients achieving a CR, VGPR, or NPR proceed to stem cell mobilization and in vivo purging.

        -  Stem cell mobilization and in vivo purging: Beginning 8-10 weeks after the first day of
           the last course of remission induction or CHOP, patients receive rituximab IV on days 1
           and 8, cyclophosphamide IV over 4 hours on day 2, and filgrastim (G-CSF) SC daily
           beginning on day 4 and continuing until the last day of apheresis. Patients undergo
           apheresis on days 11-14.

      PROJECTED ACCRUAL: A total of 17-41 patients will be accrued for this study within 3 years.
    

Intervention name(s): filgrastim; rituximab; CHOP regimen; cladribine; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): filgrastim; rituximab; CHOP regimen; cladribine; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Cladribine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell chronic lymphocytic leukemia; refractory chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia