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
Not Enrolling
Both
Myeloid Leukemia

Thank you

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

Name

Location