Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
1 other identifier
interventional
84
0 countries
N/A
Brief Summary
The purpose of this study is to determine if a single dose of pegfilgrastim is able to reduce the time of severe neutropenia in patients receiving induction and consolidation myelosuppressive chemotherapy for de novo acute myeloid leukemia similar to filgrastim.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2003
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 17, 2005
CompletedFirst Posted
Study publicly available on registry
June 20, 2005
CompletedOctober 31, 2008
October 1, 2008
1.1 years
June 17, 2005
October 30, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.
Induction cycle 1
Secondary Outcomes (1)
Duration of severe neutropenia during induction chemotherapy
Induction cycle 1
Study Arms (2)
pegfilgrastim
EXPERIMENTALPegfilgrastim given once after induction chemotherapy
filgrastim
ACTIVE COMPARATORFilgrastim given daily after induction chemotherapy
Interventions
Eligibility Criteria
You may not qualify if:
- Life expectancy, with treatment, \> 3 months
- Age \> 18 years
- ECOG performance status 0, 1 or 2
- Adequate organ function to receive protocol specified chemotherapy
- 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 \[(-5/del(5q), -7/del(7q), t(8;21) with del (9q) or complex karyotype, inv(3q), abn 11q23, 20q, 21q, del(9q), t(6;9), t(9;22), abn 17p, complex karyotypes(\>3 abnormalities)\]
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
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.
PMID: 18616811RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 17, 2005
First Posted
June 20, 2005
Study Start
March 1, 2003
Primary Completion
April 1, 2004
Study Completion
August 1, 2004
Last Updated
October 31, 2008
Record last verified: 2008-10