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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00114764
Other study ID # 20020163
Secondary ID
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


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
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