Myeloid LeukemiaPhase 2NCT00114764
Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
A Phase 2 study testing filgrastim and pegfilgrastim in people with Myeloid Leukemia, run by Amgen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Leukemia
- What is being tested?
- filgrastim and pegfilgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Aug 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)]
About this study
Official title: A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
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.
- Conditions
- Myeloid Leukemia
- Being tested
- filgrastim, pegfilgrastim
- Keywords
- Acute myeloid leukaemia, Pegfilgrastim, Neulasta®, Neutropenia, Induction chemotherapy, Consolidation
- Medical subject headings
- Leukemia, Myeloid, Leukemia, Myeloid, Acute, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimDrug
Filgrastim given daily after induction chemotherapy
pegfilgrastimDrug
Pegfilgrastim given once after induction chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| pegfilgrastim | Experimental | Pegfilgrastim given once after induction chemotherapy Receives: Drug: pegfilgrastim |
| filgrastim | Active comparator | Filgrastim given daily after induction chemotherapy Receives: Drug: filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.
Measured: Induction cycle 1
Secondary outcomes (1)
Duration of severe neutropenia during induction chemotherapy
Measured: Induction cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2005 (estimated)
- Study startMar 2003
- Primary completionApr 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114764
- Sponsor's protocol ID
- 20020163
- Status last verified
- Oct 2008
- First submitted
- 17 Jun 2005
- Last updated
- 31 Oct 2008
- Results posted
- No
Publications
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.
PubMed 18616811
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
- ClinicalTrials.gov ID
- NCT00114764
- Acronym / sponsor ID
- 20020163
- Conditions
- Myeloid Leukemia
- Keywords
- Acute myeloid leukaemia, Pegfilgrastim, Neulasta®, Neutropenia, Induction chemotherapy, Consolidation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 20 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pegfilgrastim | Experimental | Drug: pegfilgrastimPegfilgrastim given once after induction chemotherapy |
| filgrastim | Active comparator | Drug: filgrastimFilgrastim given daily after induction chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastimFilgrastim given daily after induction chemotherapy | Drug | filgrastim |
| pegfilgrastimPegfilgrastim given once after induction chemotherapy | Drug | pegfilgrastim |
Primary outcome
Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.
Time frame: Induction cycle 1
1 secondary outcome
Duration of severe neutropenia during induction chemotherapy
Time frame: Induction cycle 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2008.
- Results publication: PubMed 18616811Sierra 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim and pegfilgrastim in people with Myeloid Leukemia, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1. (time frame: Induction cycle 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00114764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2008.