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Colony-Stimulating Factors to Relieve Neutropenia in Patients With Recurrent Non-Hodgkin's Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT00004192•University of Nebraska

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 120 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

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

Key Dates

Start Date

May 1, 2000

Primary Completion Date

February 1, 2001

Completion Date

March 16, 2001

Last Updated

December 27, 2023

Enrollment

ESTIMATED participants

Conditions

LymphomaNeutropenia

Interventions

filgrastim

BIOLOGICAL

pegfilgrastim

BIOLOGICAL

cisplatin

DRUG

cytarabine

DRUG

etoposide

DRUG

methylprednisolone

DRUG

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DLBCLDiffuse Large B-Cell Lymphoma

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RECRUITINGPHASE2

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Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)