Rituximab and Combination Chemotherapy Combined With Yttrium Y 90 Ibritumomab Tiuxetan in Treating Older Patients With Previously Untreated B-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can
      locate cancer cells and either kill them or deliver radioactive cancer-killing substances to
      them without harming normal cells. Drugs used in chemotherapy use different ways to stop
      cancer cells from dividing so they stop growing or die. Combining rituximab and combination
      chemotherapy with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combining rituximab and combination
      chemotherapy with yttrium Y 90 ibritumomab tiuxetan in treating older patients who have
      B-cell lymphoma that has not been previously treated.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the progression-free and overall survival of patients age 60 and over with
           previously untreated diffuse large B-cell lymphoma treated with rituximab,
           cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) combined with
           yttrium Y 90 ibritumomab tiuxetan.

        -  Determine the incidence of adverse experiences, hematologic toxicity (WBC, hemoglobin,
           and platelet nadirs; and transfusion requirements), cardiac toxicity (incidence of left
           ventricular dysfunction and cardiomyopathy by echocardiography), and the development of
           human antimouse antibody/human anti-chimeric antibody in patients treated with this
           regimen.

        -  Determine the predictive value of detecting minimal residual disease by molecular
           techniques for future relapse/recurrence in patients treated with this regimen.

        -  Determine the response rate of patients treated with this regimen.

        -  Determine the red blood cell transfusion requirements, change in hemoglobin from
           baseline, and incidence of anemia with prophylactic darbepoetin alfa support in patients
           treated with this regimen.

        -  Determine the conversion rate to complete remission in patients treated with ibritumomab
           tiuxetan who achieve a partial remission post-R-CHOP.

        -  Determine the effect of darbepoetin alfa on the quality of life of these patients.

      OUTLINE: This is an open-label, nonrandomized study.

        -  Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV,
           doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and
           filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin
           alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of
           disease progression or unacceptable toxicity.

        -  Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111
           ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.

      Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of
      IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then
      patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7.

      Quality of life is assessed at baseline, before course 5 of chemotherapy, before
      radioimmunotherapy, and at 3 months.

      Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

      PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
    

Intervention name(s): darbepoetin alfa; filgrastim; rituximab; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate; indium In 111 ibritumomab tiuxetan; yttrium Y 90 ibritumomab tiuxetan
Intervention type(s): Biological; Biological; Biological; Drug; Drug; Drug; Drug; Radiation; Radiation
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine; Darbepoetin alfa; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: noncontiguous stage II adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma