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

Phase 2

Completed

• Conditions: Neutropenia; Lymphoma
• Interventions: Biological: filgrastim; Biological: pegfilgrastim; Drug: cisplatin; Drug: cytarabine; Drug: etoposide; Drug: methylprednisolone

• Registration Number: NCT00004192
• Lead Sponsor: University of Nebraska

Brief 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.

Study Timeline

• Study First Submitted: 2000-01-21
• Study Start: 2000-05-01
• Primary Completion: 2001-02-01
• Study Completion: 2001-03-16
• Study First Submitted QC: 2004-06-24
• Study First Posted: 2004-06-25
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily Filgrastim (G-CSF)	cytarabine	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.
Single Dose Filgrastim (SD/01)	filgrastim	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.
Daily Filgrastim (G-CSF)	pegfilgrastim	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.
Single Dose Filgrastim (SD/01)	etoposide	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.
Single Dose Filgrastim (SD/01)	cisplatin	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.
Single Dose Filgrastim (SD/01)	cytarabine	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.
Daily Filgrastim (G-CSF)	cisplatin	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.
Daily Filgrastim (G-CSF)	etoposide	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.
Single Dose Filgrastim (SD/01)	methylprednisolone	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.
Daily Filgrastim (G-CSF)	methylprednisolone	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.

Trial Locations

Locations (3)

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Ireland Cancer Center; 🇺🇸 Cleveland, Ohio, United States