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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00114764
First received: June 17, 2005
Last updated: October 30, 2008
Last verified: October 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of severe neutropenia during induction chemotherapy [ Time Frame: Induction cycle 1 ] [ Designated as safety issue: No ]

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
Other Name: pegfilgrastim
Active Comparator: filgrastim
Filgrastim given daily after induction chemotherapy
Drug: filgrastim
Filgrastim given daily after induction chemotherapy
Other Name: filgrastim

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 17, 2005
Last Updated: October 30, 2008
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014