Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma
Condition: Lymphoma; Neutropenia
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Colony-stimulating factors may increase the number of immune cells found in bone
      marrow or peripheral blood and may help a person's immune system recover from the side
      effects of chemotherapy.

      PURPOSE: Randomized phase II trial to compare the effectiveness of filgrastim-SD/01 with that
      of filgrastim to relieve the neutropenia following combination chemotherapy in patients who
      have non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Compare the effect of single dose filgrastim-SD/01 vs daily filgrastim (G-CSF)
      on the duration of neutropenia in course 1 after combination chemotherapy in patients with
      recurrent non-Hodgkin's lymphoma. II. Compare the effect of these regimens on duration of
      neutropenia in courses 2-4, absolute neutrophil counts (ANC) in courses 1-4, time to ANC
      recovery in courses 1-4, and safety in these patients. III. Determine the pharmacokinetic
      profile of these drugs in course 1 in these patients.

      OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one
      of two treatment arms. All patients receive etoposide IV over 1 hour on days 1-4, cisplatin
      IV continuously on days 1-4, methylprednisolone IV over 15 minutes on days 1-5, and
      cytarabine IV over 2 hours on day 5. Treatment is repeated every 21 days for up to 4 courses.
      Arm I: Patients receive filgrastim-SD/01 subcutaneously (SQ) on day 6. Arm II: Patients
      receive filgrastim (G-CSF) SQ daily beginning on day 6 and continuing for 12 days or until
      blood counts recover.

      PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within
      at least 6 months.
    

Intervention name(s): filgrastim; pegfilgrastim; cisplatin; cytarabine; etoposide; methylprednisolone
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug
Other intervention name(s): Neupogen; Neulasta; chemotherapy drug; cytosine arabinoside; Etopophos, Toposar; Depo-Medrol, Medrol, Solu-Medrol, P-Care D80, ReadySharp Methylprednisolone, and P-Care D40
Intervention MeSH terms: Cytarabine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Etoposide; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. All patients receive etoposide IV over 1 hour on days 1-4, cisplatin IV continuously on days 1-4, methylprednisolone IV over 15 minutes on days 1-5, and cytarabine IV over 2 hours on day 5. Treatment is repeated every 21 days for up to 4 courses. Arm I: Patients receive filgrastim-SD/01 subcutaneously (SQ) on day 6. Arm II: Patients receive filgrastim (G-CSF) SQ daily beginning on day 6 and continuing for 12 days or until blood counts recover.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: neutropenia; Waldenstrom macroglobulinemia; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult Burkitt 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