Rituximab, Cyclophosphamide, and G-CSF Followed By Combination Chemotherapy in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant Followed By Rituximab and GM-CSF for Refractory Diffuse Large B-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as
      rituximab, and chemotherapy, such as cyclophosphamide, helps stem cells move from the
      patient's bone marrow to the blood so they can be collected and stored for peripheral stem
      cell transplant. Giving chemotherapy, such as carmustine, etoposide, and cyclophosphamide,
      before transplant stops the growth of cancer cells by stopping them from dividing or killing
      them. The stem cells are then returned to the patient to replace the blood-forming cells that
      were destroyed by the chemotherapy. More rituximab is given after transplant to kill any
      remaining cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with
      cyclophosphamide and G-CSF followed by combination chemotherapy works in treating patients
      undergoing an autologous stem cell transplant followed by rituximab and GM-CSF for refractory
      diffuse large B-cell lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the disease-free and overall survival of patients with refractory diffuse
           large B-cell lymphoma treated with stem cell mobilization comprising rituximab,
           cyclophosphamide, and filgrastim (G-CSF) followed by high-dose chemotherapy comprising
           carmustine, etoposide, and cyclophosphamide and autologous peripheral blood stem cell
           transplantation, rituximab, and sargramostim (GM-CSF).

        -  Determine any potential infectious complications in patients treated with this regimen.

        -  Determine the effect of GM-CSF on antibody-dependent cellular cytotoxicity in patients
           treated with this regimen.

      OUTLINE: Stem cell mobilization: Patients receive rituximab IV over 4-8 hours on days 1, 5,
      8, and 13. Patients also receive cyclophosphamide IV over 1-2 hours on day 9 and filgrastim
      (G-CSF) subcutaneously (SC) once daily beginning on day 10 and continuing until an adequate
      number of peripheral blood stem cells (PBSC) are collected.

      High-dose preparative regimen: Patients receive carmustine IV over 2 hours on day -6,
      etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on day -2.

      Autologous PBSC transplantation: Patients undergo autologous PBSC transplantation on day 0.
      Patients receive sargramostim (GM-CSF) SC once daily beginning on day 6 and continuing until
      blood counts recover.

      Post-transplant regimen: Patients receive GM-CSF SC once daily on days 42-73, 177-208,
      362-393, 543-574, and 727-758. Patients also receive rituximab IV over 4-8 hours on days 45,
      52, 59, 66, 180,187, 194, 201, 365, 372, 379, 386, 546, 553, 560, 567, 730, 737, 744, and
      751.

      After completion of study treatment, patients are followed periodically for 10 years.

      PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
    

Intervention name(s): filgrastim; rituximab; sargramostim; carmustine; cyclophosphamide; etoposide; adjuvant therapy; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Biological; Drug; Drug; Drug; Procedure; Procedure; Procedure
Intervention MeSH terms: Cyclophosphamide; Carmustine; Rituximab; Etoposide; Sargramostim
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult diffuse large cell lymphoma