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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00114764

Enrollment

Registered

2005-06-20

Start date

2003-03-31

Completion date

2004-08-31

Last updated

2008-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myeloid Leukemia

Keywords

Acute myeloid leukaemia, Pegfilgrastim, Neulasta®, Neutropenia, Induction chemotherapy, Consolidation

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.

Interventions

DRUGfilgrastim

Filgrastim given daily after induction chemotherapy

DRUGpegfilgrastim

Pegfilgrastim given once after induction chemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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 \[(-5/del(5q), -7/del(7q), t(8;21) with del (9q) or complex karyotype, inv(3q), abn 11q23, 20q, 21q, del(9q), t(6;9), t(9;22), abn 17p, complex karyotypes(\>3 abnormalities)\]

Design outcomes

Primary

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

Secondary

Measure	Time frame
Duration of severe neutropenia during induction chemotherapy	Induction cycle 1

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026