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

Phase 2

Completed

• Conditions: Myeloid Leukemia
• Interventions: Drug: filgrastim; Drug: pegfilgrastim

• Registration Number: NCT00114764
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2004-04
• Study Completion: 2004-08
• Study First Submitted: 2005-06-17
• Study First Submitted QC: 2005-06-17
• Study First Posted: 2005-06-20
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-30
• Last Update Posted: 2008-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
filgrastim	filgrastim	Filgrastim given daily after induction chemotherapy
pegfilgrastim	pegfilgrastim	Pegfilgrastim given once after induction chemotherapy

Primary Outcome Measures

Name	Time	Method
Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.	Induction cycle 1

Secondary Outcome Measures

Name	Time	Method
Duration of severe neutropenia during induction chemotherapy	Induction cycle 1