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Completed

NCT Number: NCT00114764

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

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.

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Key information

Conditions

Myeloid Leukemia Agranulocytosis Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Histologic Type Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)]

Treatment and study plan

Filgrastim

Drug

Filgrastim given daily after induction chemotherapy

pegfilgrastim

Drug

Pegfilgrastim given once after induction chemotherapy

Primary outcomes

  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 outcomes

  1. Duration of severe neutropenia during induction chemotherapy

    Time frame: Induction cycle 1

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jun 20, 2005
Registry last updated
Oct 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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