NCT00114764CompletedPhase 2
A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 84
- Primary Endpoint
- Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.
Study Overview
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 chemotherapy for de novo acute myeloid leukemia similar to filgrastim.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
pegfilgrastim
Experimental
Pegfilgrastim given once after induction chemotherapy
Intervention: pegfilgrastim (Drug)
filgrastim
Active Comparator
Filgrastim given daily after induction chemotherapy
Intervention: filgrastim (Drug)
Outcomes
Primary Outcomes
Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.
Time Frame: Induction cycle 1
Secondary Outcomes
- Duration of severe neutropenia during induction chemotherapy(Induction cycle 1)
Investigators
Similar Trials
Completed
Phase 2
A Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim in Subjects With Non-Hodgkin's LymphomaNon-Hodgkin's LymphomaNCT00117455Amgen
Completed
Phase 2
Same Day Dosing of Pegfilgrastim in Breast Cancer Patients Undergoing Chemotherapy (TAC)FeverNeutropeniaBreast CancerNCT00115414Amgen
Completed
Phase 2
Pegfilgrastim Administered on the Same Day as Chemotherapy in Non-Hodgkin's LymphomaNon-Hodgkin's LymphomaNCT00115193Amgen77
Completed
Phase 3
Study of the Efficacy and Safety of Empegfilgrastim for Neutropenia Prophylaxis in Breast Cancer PatientsChemotherapy-induced NeutropeniaNCT02104830Biocad135
Completed
Phase 2
Evaluating Pegfilgrastim and a Multi-Day Topotecan Regimen in Subjects With Relapsed or Refractory Ovarian CancerOvarian CancerNCT00113789Amgen21