Status:
COMPLETED
Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
Lead Sponsor:
Amgen
Conditions:
Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 chemothe...
Eligibility Criteria
Inclusion
- 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 \[(-5/del(5q), -7/del(7q), t(8;21) with del (9q) or complex karyotype, inv(3q), abn 11q23, 20q, 21q, del(9q), t(6;9), t(9;22), abn 17p, complex karyotypes(\>3 abnormalities)\]
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00114764
Start Date
March 1 2003
End Date
August 1 2004
Last Update
October 31 2008
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