NCT00125723

Brief Summary

The purpose of the study is to assess the impact of first and subsequent cycle pegfilgrastim on neutropenia events (such as hospitalizations, dose reductions and delays) in patients receiving myelosuppressive chemotherapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,252

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2004

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

May 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 23, 2010

Status Verified

December 1, 2010

Enrollment Period

1.6 years

First QC Date

July 29, 2005

Last Update Submit

December 22, 2010

Conditions

Neutropenia

Keywords

Phase 4 Clinical TrialChemotherapyNeulasta®OncologyMalignancy

Outcome Measures

Primary Outcomes (1)

  • dose delays and dose reductions and neutropenic events

    during treatment

Study Arms (2)

No Intervention

NO INTERVENTION
Other: PI Discretion

Intervention

OTHER

PI Discretion

Other: PI Discretion

Interventions

PI DiscretionOTHER

PI Discretion

InterventionNo Intervention

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Noga SJ, Choksi JK, Ding B, Dreiling L, Ozer H. Low incidence of neutropenic events in patients with lymphoma receiving first-cycle pegfilgrastim with chemotherapy: results from a prospective community-based study. Clin Lymphoma Myeloma. 2007 May;7(6):413-20. doi: 10.3816/CLM.2007.n.020.

    PMID: 17621407RESULT

  • Ozer H, Mirtsching B, Rader M, Luedke S, Noga SJ, Ding B, Dreiling L. Neutropenic events in community practices reduced by first and subsequent cycle pegfilgrastim use. Oncologist. 2007 Apr;12(4):484-94. doi: 10.1634/theoncologist.12-4-484.

    PMID: 17470691RESULT

Related Links

MeSH Terms

Conditions

NeutropeniaNeoplasms

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 2, 2005

Study Start

May 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

December 23, 2010

Record last verified: 2010-12