Rituximab, Carmustine; Cytarabine, Etoposide, & Melphalan; Stem Cell Transplantation for Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill
      them or deliver cancer-killing substances to them without harming normal cells. Drugs used in
      chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different
      ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and
      combination chemotherapy with autologous stem cell transplantation may allow the doctor to
      give higher doses of chemotherapy drugs and kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination
      chemotherapy followed by autologous hematopoietic stem cell transplantation in treating
      patients who have B-cell non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the levels of soluble CD20 antigen (sCD20) in the blood before and after
           treatment with rituximab and carmustine, cytarabine, etoposide, and melphalan followed
           by autologous hematopoietic stem cell transplantation in patients with CD20-positive
           B-cell non-Hodgkin's lymphoma.

        -  Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients
           treated with this regimen.

        -  Determine the response rate in patients treated with this regimen.

        -  Determine the event-free survival of patients treated with this regimen.

        -  Determine the toxicity profile of this regimen in these patients.

      OUTLINE: Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks
      followed 1 week later by hematopoietic stem cell or bone marrow harvest.

      Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or
      -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6,
      cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1.
      Patients undergo autologous hematopoietic stem cell transplantation on day 0.

      Patients who have less than a complete remission at day 100 post-transplantation receive 4
      additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks.

      Patients are followed at day 100, at 1 year, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
    

Intervention name(s): rituximab; carmustine; cytarabine; etoposide; melphalan; autologous bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure; Procedure
Other intervention name(s): Rituxan; Gliadel Wafer, Bicnu; cytosine arabinoside; Etopophos, Toposar; Evomela
Intervention MeSH terms: Cytarabine; Rituximab; Etoposide; Melphalan; Carmustine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult Burkitt lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma