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

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Lenograstim

Criteria

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)]