NCT00117897

Brief Summary

This multicenter, open-label, randomized, parallel study was designed to evaluate whether a single fixed-dose subcutaneous (SC) administration of pegfilgrastim or daily administration of Filgrastim for absolute neutrophil count (ANC) support would assist in allowing the planned dose-on-time (PDOT) of cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) chemotherapy with Rituximab every 14 days in subjects with aggressive B-cell Non-Hodgkin's Lymphoma by reducing the duration of neutropenia and incidence of febrile neutropenia.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2002

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

Study Start

First participant enrolled

July 1, 2002

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
Last Updated

July 20, 2009

Status Verified

July 1, 2009

First QC Date

June 30, 2005

Last Update Submit

July 16, 2009

Conditions

Non-Hodgkin's Lymphoma

Keywords

non-Hodgkin's lymphomaR-CHOP-14pegfilgrastimneutropenia, clinical trialhaematopoietic growth factor

Outcome Measures

Primary Outcomes (1)

  • The primary objective was to provide preliminary information on the ability of pegfilgrastim or Filgrastim to support planned dose on time (PDOT) application of CHOP chemotherapy with Rituximab given every 14 days, to subjects with NHL.

Secondary Outcomes (4)

  • The proportion of chemotherapy cycles given at the PDOT in both arms.

  • Response rates (complete response and partial response) in both arms

  • The safety profile in cycles 1-6

  • Subject self-reported outcomes

Interventions

pegfilgrastimDRUG
FilgrastimDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Lymphoma, Non-HodgkinNeutropenia

Interventions

pegfilgrastimFilgrastim

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 11, 2005

Study Start

July 1, 2002

Study Completion

February 1, 2004

Last Updated

July 20, 2009

Record last verified: 2009-07