A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Myeloid Leukemia
Both
Myeloid Leukemia
Trial Information
A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
Inclusion 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)]
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.
Outcome Time Frame:
Induction cycle 1
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
European Union: European Medicines Agency
Study ID:
20020163
NCT ID:
NCT00114764
Start Date:
March 2003
Completion Date:
August 2004
Related Keywords:
- Myeloid Leukemia
- Acute myeloid leukaemia
- Pegfilgrastim
- Neulasta®
- Neutropenia
- Induction chemotherapy
- Consolidation
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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