Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
NCT ID: NCT00114764
Last Updated: 2008-10-31
Study Results
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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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2003-03-31
2004-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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pegfilgrastim
Pegfilgrastim given once after induction chemotherapy
pegfilgrastim
Pegfilgrastim given once after induction chemotherapy
filgrastim
Filgrastim given daily after induction chemotherapy
filgrastim
Filgrastim given daily after induction chemotherapy
Interventions
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filgrastim
Filgrastim given daily after induction chemotherapy
pegfilgrastim
Pegfilgrastim given once after induction chemotherapy
Eligibility Criteria
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Exclusion Criteria
* Age \> 18 years
* ECOG performance status 0, 1 or 2
* Adequate organ function to receive protocol specified chemotherapy
Exclusion
* Subjects in blast transformation of chronic myeloid leukaemia (CML)
* Patients with secondary AML (Received previous chemotherapy or radiotherapy)
* Previous treatment for AML
* Patients with AML FAB type M3 (Acute Promyelocytic Leukemia, APL) or M7
* High risk (Unfavourable) cytogenetics \[(-5/del(5q), -7/del(7q), t(8;21) with del (9q) or complex karyotype, inv(3q), abn 11q23, 20q, 21q, del(9q), t(6;9), t(9;22), abn 17p, complex karyotypes(\>3 abnormalities)\]
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Amgen Inc.
Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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Sierra J, Szer J, Kassis J, Herrmann R, Lazzarino M, Thomas X, Noga SJ, Baker N, Dansey R, Bosi A. A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-to-intermediate risk acute myeloid leukemia: results from a randomized, double-blind, phase 2 trial. BMC Cancer. 2008 Jul 10;8:195. doi: 10.1186/1471-2407-8-195.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20020163
Identifier Type: -
Identifier Source: org_study_id