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

December 19, 2023 updated by: University of Nebraska

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3330
        • University of Nebraska Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: cytarabine
Other Names:
  • cytosine arabinoside
Drug: etoposide
Other Names:
  • Etopophos, Toposar
Drug: methylprednisolone
Other Names:
  • Depo-Medrol, Medrol, Solu-Medrol, P-Care D80, ReadySharp Methylprednisolone, and P-Care D40
Drug: cisplatin
Other Names:
  • chemotherapy drug
Biological: filgrastim
Other Names:
  • Neupogen
Experimental: 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.
Drug: cytarabine
Other Names:
  • cytosine arabinoside
Drug: etoposide
Other Names:
  • Etopophos, Toposar
Drug: methylprednisolone
Other Names:
  • Depo-Medrol, Medrol, Solu-Medrol, P-Care D80, ReadySharp Methylprednisolone, and P-Care D40
Drug: cisplatin
Other Names:
  • chemotherapy drug
Biological: pegfilgrastim
Other Names:
  • Neulasta

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Julie M Vose, MD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2000

Primary Completion (Actual)

February 1, 2001

Study Completion (Actual)

March 16, 2001

Study Registration Dates

First Submitted

January 21, 2000

First Submitted That Met QC Criteria

June 24, 2004

First Posted (Estimated)

June 25, 2004

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0272-99-FB
  • P30CA036727 (U.S. NIH Grant/Contract)
  • AMGEN-990117 (Other Grant/Funding Number: Amgen, Inc.)
  • CWRU-AMGN-1499 (Other Identifier: Ireland Cancer Center)
  • UCLA-9906080 (Other Identifier: Jonsson Comprehensive Cancer Center, UCLA)
  • NCI-G99-1648 (Registry Identifier: National Cancer Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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