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Study Complete
Sponsor ID
20020163

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

Sponsor ID
20020163
Clinicaltrials.gov ID
NCT00114764
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
pegfilgrastim
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
84
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Induction cycle 1

Secondary Outcome Measures

Duration of severe neutropenia during induction chemotherapy

Timeframe: Induction cycle 1

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Leukemia
    • Sex
    All
    Trial Dates
    Mar 2003 - Apr 2004
    Inclusion and Exclusion 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)]