Clinical Trials Directory

Trials / Completed

CompletedNCT00114764

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
84 (actual)
Sponsor
Amgen · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGfilgrastimFilgrastim given daily after induction chemotherapy
DRUGpegfilgrastimPegfilgrastim given once after induction chemotherapy

Timeline

Start date
2003-03-01
Primary completion
2004-04-01
Completion
2004-08-01
First posted
2005-06-20
Last updated
2008-10-31

Source: ClinicalTrials.gov record NCT00114764. Inclusion in this directory is not an endorsement.