drugset / Trial / NCT00114764

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

NCT00114764

Phase 2 Completed 84 enrolled Amgen
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2003-03
Primary completion
2004-04
Completion
2004-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegfilgrastim Protein / enzyme biologic 6 mg
Comparator filgrastim Protein / enzyme biologic 5 ug/kg

Indications