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)

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.

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)]