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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

filgrastim

pegfilgrastim

About this trial

This is an interventional treatment trial for Myeloid Leukemia focused on measuring Acute myeloid leukaemia, Pegfilgrastim, Neulasta®, Neutropenia, Induction chemotherapy, Consolidation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)]

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pegfilgrastim

filgrastim

Arm Description

Pegfilgrastim given once after induction chemotherapy

Filgrastim given daily after induction chemotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of severe neutropenia during induction chemotherapy

Full Information

NCT ID

NCT00114764

First Posted

June 17, 2005

Last Updated

October 30, 2008

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00114764

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

April 2004 (Actual)

Study Completion Date

August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Amgen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myeloid Leukemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pegfilgrastim

Arm Type

Experimental

Arm Description

Pegfilgrastim given once after induction chemotherapy

Arm Title

filgrastim

Arm Type

Active Comparator

Arm Description

Filgrastim given daily after induction chemotherapy

Intervention Type

Drug

Intervention Name(s)

filgrastim

Intervention Description

Filgrastim given daily after induction chemotherapy

Intervention Type

Drug

Intervention Name(s)

pegfilgrastim

Intervention Description

Pegfilgrastim given once after induction chemotherapy

Primary Outcome Measure Information:

Title

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

Time Frame

Induction cycle 1

Secondary Outcome Measure Information:

Title

Duration of severe neutropenia during induction chemotherapy

Time Frame

Induction cycle 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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)]

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MD

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

18616811

Citation

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 myeloid leukemia: results from a randomized, double-blind, phase 2 trial. BMC Cancer. 2008 Jul 10;8:195. doi: 10.1186/1471-2407-8-195.

Results Reference

result

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Myeloid Leukemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial