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

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ClinicalTrials.gov Identifier: NCT00114764
Recruitment Status : Completed
First Posted : June 20, 2005
Last Update Posted : October 31, 2008
Sponsor:
Information provided by:
Amgen

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.

Condition or disease Intervention/treatment Phase
Myeloid Leukemia Drug: filgrastim Drug: pegfilgrastim Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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)
Study Start Date : March 2003
Actual Primary Completion Date : April 2004
Actual Study Completion Date : August 2004


Arm Intervention/treatment
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



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


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

Inclusion

  • 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

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)]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114764


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00114764     History of Changes
Other Study ID Numbers: 20020163
First Posted: June 20, 2005    Key Record Dates
Last Update Posted: October 31, 2008
Last Verified: October 2008

Keywords provided by Amgen:
Acute myeloid leukaemia
Pegfilgrastim
Neulasta®
Neutropenia
Induction chemotherapy
Consolidation

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs