Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors

NCT ID: NCT00115128

Last Updated: 2013-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-09-30

Brief Summary

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The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.

Detailed Description

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Conditions

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Normal PBPC Donors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Filgrastim

Normal donors being treated with filgrastim for PBPC mobilization and collection

filgrastim

Intervention Type DRUG

Normal donors being treated with filgrastim for PBPC mobilization and collection

Interventions

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filgrastim

Normal donors being treated with filgrastim for PBPC mobilization and collection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Eligible to be PBPC donor for allogeneic transplantation as determined by local institution Exclusion Criteria: - History of splenectomy - Previous PBPC mobilization attempts - Previous treatment with GCSF or GMCSF
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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Stiff PJ, Bensinger W, Abidi MH, Gingrich R, Artz AS, Nademanee A, Hansen KS, Sobczak C, Cutler C, Bolwell B, Shore TB, Lazarus HM, Yeager AM, Lovelace W, Guo M, Dreiling L. Clinical and ultrasonic evaluation of spleen size during peripheral blood progenitor cell mobilization by filgrastim: results of an open-label trial in normal donors. Biol Blood Marrow Transplant. 2009 Jul;15(7):827-34. doi: 10.1016/j.bbmt.2009.03.015.

Reference Type RESULT
PMID: 19539214 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20020143

Identifier Type: -

Identifier Source: org_study_id

NCT00108966

Identifier Type: -

Identifier Source: nct_alias

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