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Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)

This study has been completed.
Information provided by:
Amgen Identifier:
First received: June 17, 2005
Last updated: October 30, 2008
Last verified: October 2008
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.

Condition Intervention Phase
Myeloid Leukemia
Drug: filgrastim
Drug: pegfilgrastim
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1. [ Time Frame: Induction cycle 1 ]

Secondary Outcome Measures:
  • Duration of severe neutropenia during induction chemotherapy [ Time Frame: Induction cycle 1 ]

Enrollment: 84
Study Start Date: March 2003
Study Completion Date: August 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pegfilgrastim
Pegfilgrastim given once after induction chemotherapy
Drug: pegfilgrastim
Pegfilgrastim given once after induction chemotherapy
Active Comparator: filgrastim
Filgrastim given daily after induction chemotherapy
Drug: filgrastim
Filgrastim given daily after induction chemotherapy


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed de novo AML as evidenced by absence of an antecedent hematologic disease of > 1 months duration, prior chemotherapy, prior radiation therapy or myelodysplastic cytogenetics (as per exclusion criteria)
  • 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)]
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Please refer to this study by its identifier: NCT00114764

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00114764     History of Changes
Other Study ID Numbers: 20020163
Study First Received: June 17, 2005
Last Updated: October 30, 2008

Keywords provided by Amgen:
Acute myeloid leukaemia
Induction chemotherapy

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017