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

October 30, 2008 updated by: Amgen

A Multicentre, Double-Blind, Randomised Phase 2 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of severe neutropenia during induction chemotherapy
Time Frame: Induction cycle 1
Induction cycle 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

June 17, 2005

First Submitted That Met QC Criteria

June 17, 2005

First Posted (Estimate)

June 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 31, 2008

Last Update Submitted That Met QC Criteria

October 30, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20020163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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