NCT00004192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started May 2000

Shorter than P25 for phase_2 lymphoma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2000

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2000

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2001

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2001

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

June 25, 2004

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

January 21, 2000

Last Update Submit

December 19, 2023

Conditions

LymphomaNeutropenia

Keywords

neutropeniaWaldenstrom macroglobulinemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Study Arms (2)

Single Dose Filgrastim (SD/01)

EXPERIMENTAL

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.

Biological: filgrastimDrug: cisplatinDrug: cytarabineDrug: etoposideDrug: methylprednisolone

Daily Filgrastim (G-CSF)

EXPERIMENTAL

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.

Biological: pegfilgrastimDrug: cisplatinDrug: cytarabineDrug: etoposideDrug: methylprednisolone

Interventions

filgrastimBIOLOGICAL
Also known as: Neupogen
Single Dose Filgrastim (SD/01)
pegfilgrastimBIOLOGICAL
Also known as: Neulasta
Daily Filgrastim (G-CSF)
cisplatinDRUG
Also known as: chemotherapy drug
Daily Filgrastim (G-CSF)Single Dose Filgrastim (SD/01)
cytarabineDRUG
Also known as: cytosine arabinoside
Daily Filgrastim (G-CSF)Single Dose Filgrastim (SD/01)
etoposideDRUG
Also known as: Etopophos, Toposar
Daily Filgrastim (G-CSF)Single Dose Filgrastim (SD/01)
methylprednisoloneDRUG
Also known as: Depo-Medrol, Medrol, Solu-Medrol, P-Care D80, ReadySharp Methylprednisolone, and P-Care D40
Daily Filgrastim (G-CSF)Single Dose Filgrastim (SD/01)

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

LymphomaNeutropeniaWaldenstrom MacroglobulinemiaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

FilgrastimpegfilgrastimCisplatinCytarabineEtoposideetoposide phosphateMethylprednisoloneMethylprednisolone AcetateMethylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesLeukocyte DisordersNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoma, B-CellLeukemia, LymphoidLeukemiaEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Study Officials

  • Julie M Vose, MD

    University of Nebraska

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2000

First Posted

June 25, 2004

Study Start

May 1, 2000

Primary Completion

February 1, 2001

Study Completion

March 16, 2001

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations

US(3)