A Randomized, Multicenter, Open-Label Study of Single Dose Filgrastim-SD/01 Versus Daily Filgrastim Following ESHAP Chemotherapy for Non-Hodgkin's Lymphoma
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.
Allocation: Randomized, Primary Purpose: Supportive Care
Julie M. Vose, MD
University of Nebraska
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|