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A Randomized, Multicenter, Open-Label Study of Single Dose Filgrastim-SD/01 Versus Daily Filgrastim Following ESHAP Chemotherapy for Non-Hodgkin's Lymphoma

Phase 2
18 Years
Not Enrolling
Lymphoma, Neutropenia

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Trial Information

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of non-Hodgkin's lymphoma (NHL) Relapsed disease OR
Refractory to first line cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)
chemotherapy No myelodysplastic syndrome or chronic myeloid leukemia

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 150,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective barrier contraception No other prior
malignancy except: Curatively treated basal cell or squamous cell carcinoma Carcinoma in
situ of the cervix Surgically cured malignancy No hypersensitivity to E. coli derived
products (e.g., filgrastim (G-CSF), insulin, asparaginase)

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow or peripheral blood stem
cell (PBSC) transplantation for NHL No prior filgrastim-SD/01 No other concurrent
myelopoietic growth factors No concurrent WBC transfusions No concurrent PBSC collection
Chemotherapy: See Disease Characteristics No more than 2 prior courses of chemotherapy for
any malignancy Endocrine therapy: No concurrent corticosteroids except topical steroids or
as premedications or associated with chemotherapy Radiotherapy: At least 4 weeks since
prior radiotherapy Surgery: Not specified Other: At least 72 hours since prior
antimicrobials At least 30 days since other prior investigational drug No other concurrent
investigational drug No concurrent prophylactic antibiotics during course 1

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Julie M. Vose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska


United States: Federal Government

Study ID:




Start Date:

May 2000

Completion Date:

March 2001

Related Keywords:

  • Lymphoma
  • Neutropenia
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Neutropenia



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