Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-01

Study Completion Date

2001-03-16

Brief Summary

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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

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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.

Conditions

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Lymphoma Neutropenia

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Single Dose Filgrastim (SD/01)

Participants 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: Participants receive filgrastim-SD/01 subcutaneously (SQ) on day 6.

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

cisplatin

Intervention Type DRUG

cytarabine

Intervention Type DRUG

etoposide

Intervention Type DRUG

methylprednisolone

Intervention Type DRUG

Daily Filgrastim (G-CSF)

Participants 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 II: Participants receive filgrastim (G-CSF) SQ daily beginning on day 6 and continuing for 12 days or until blood counts recover.

Group Type EXPERIMENTAL

pegfilgrastim

Intervention Type BIOLOGICAL

cisplatin

Intervention Type DRUG

cytarabine

Intervention Type DRUG

etoposide

Intervention Type DRUG

methylprednisolone

Intervention Type DRUG

Interventions

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filgrastim

Intervention Type BIOLOGICAL

pegfilgrastim

Intervention Type BIOLOGICAL

cisplatin

Intervention Type DRUG

cytarabine

Intervention Type DRUG

etoposide

Intervention Type DRUG

methylprednisolone

Intervention Type DRUG

Other Intervention Names

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Neupogen Neulasta chemotherapy drug cytosine arabinoside Etopophos, Toposar Depo-Medrol, Medrol, Solu-Medrol, P-Care D80, ReadySharp Methylprednisolone, and P-Care D40

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of non-Hodgkin's lymphoma (NHL)

o Relapsed disease or Refractory to first line cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy
* Age 18 and over
* ECOG 0-2Absolute neutrophil count at least 1,500/mm3Platelet count at least 150,000/mm3
* Creatinine not greater than 1.5 mg/dL or Creatinine clearance greater than 60 mL/min
* Fertile patients must use effective barrier contraception
* At least 4 weeks since prior radiotherapy
* At least 72 hours since prior antimicrobials
* At least 30 days since other prior investigational drug

Exclusion Criteria

* No myelodysplastic syndrome or chronic myeloid leukemia
* Not pregnant or nursing/Negative pregnancy test
* 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)
* 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
* No more than 2 prior courses of chemotherapy for any malignancy
* No concurrent corticosteroids except topical steroids or as pre-medications or associated with chemotherapy
* No other concurrent investigational drug
* No concurrent prophylactic antibiotics during course 1

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie M Vose, MD

Role: STUDY_CHAIR

University of Nebraska

Locations

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Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Ireland Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States