Clinical trial · Interventional
Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
NCT00114764CI-TRIAL-00001760completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloid Leukemia | Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Drug | Filgrastim | ALIAS |
| pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- pegfilgrastim
- description
- Pegfilgrastim given once after induction chemotherapy
- interventionNames
- Drug: pegfilgrastim
- type
- ACTIVE_COMPARATOR
- label
- filgrastim
- description
- Filgrastim given daily after induction chemotherapy
- interventionNames
- Drug: filgrastim
Primary outcomes (1)
- measure
- Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.
- timeFrame
- Induction cycle 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \[(-5/del(5q), -7/del(7q), t(8;21) with del (9q) or complex karyotype, inv(3q), abn 11q23, 20q, 21q, del(9q), t(6;9), t(9;22), abn 17p, complex karyotypes(\>3 abnormalities)\]
References
Publications (1)
- RESULTSierra J, Szer J, Kassis J, Herrmann R, Lazzarino M, Thomas X, Noga SJ, Baker N, Dansey R, Bosi A. A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-to-intermediate risk acute myeloid leukemia: results from a randomized, double-blind, phase 2 trial. BMC Cancer. 2008 Jul 10;8:195. doi: 10.1186/1471-2407-8-195. PMID 18616811