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

Amgen

Status and phase

Completed

Phase 2

Conditions

Myeloid Leukemia

Treatments

Drug: filgrastim

Drug: pegfilgrastim

Study type

Interventional

Funder types

Industry

Identifiers

NCT00114764

20020163

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)]