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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114764
First Posted: June 20, 2005
Last Update Posted: October 31, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Amgen
  Purpose
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: 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)

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

  Eligibility

Information from the National Library of Medicine

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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)]
  Contacts and Locations
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
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00114764     History of Changes
Other Study ID Numbers: 20020163
First Submitted: June 17, 2005
First Posted: June 20, 2005
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