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

Myeloid Leukemia Clinical Trial

Official title:

A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114764
• Other study ID #: 20020163
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2005
• Last updated: October 30, 2008
• Start date: March 2003
• Est. completion date: August 2004

Study information

• Verified date: October 2008
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)]

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myeloid Leukemia

Intervention

Drug:
• filgrastim
Filgrastim given daily after induction chemotherapy
• pegfilgrastim
Pegfilgrastim given once after induction chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Sierra J, Szer J, Kassis J, Herrmann R, Lazzarino M, Thomas X, Noga SJ, Baker N, Dansey R, Bosi A. A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-to-intermediate risk acute myel — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.		Induction cycle 1	No
Secondary	Duration of severe neutropenia during induction chemotherapy		Induction cycle 1	No

External Links

•   AmgenTrials clinical trials website