TrialSignal
Clinical trial intelligence report
RANDOMIZED PHASE III STUDY TO EVALUATE THE VALUE OF rHuG-CSF IN INDUCTION AND OF AN ORAL SCHEDULE AS CONSOLIDATION TREATMENT IN ELDERLY PATIENTS WITH ACUTE MYELOGENOUS LEUMEKIA (AML-13 PROTOCOL)
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 25, 2026
Report code
NCT00002719-Jun 25, 2026
NCT ID
NCT00002719
Status
COMPLETED
Phase
Phase 3
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Executive brief
Investment-Ready Snapshot
The EORTC's AML-13 trial evaluates the efficacy of rHuG-CSF in combination with chemotherapy for elderly patients with acute myeloid leukemia (AML). Given the aging population and the increasing incidence of AML, this study addresses a significant unmet medical need. The results could position rHuG-CSF as a critical adjunct therapy in AML treatment regimens, potentially enhancing market share for the sponsor and collaborators. The competitive landscape includes other G-CSF formulations and alternative therapies, necessitating a thorough analysis of clinical outcomes and market positioning. Diligence should focus on the trial's results and subsequent regulatory pathways for commercialization.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT00002719
Indication
Leukemia
Modality
protein therapy
Target
Granulocyte Colony-Stimulating Factor (G-CSF)
Intervention
filgrastim, amsacrine, carmustine, cytarabine, etoposide, idarubicin, mitoxantrone hydrochloride, peripheral blood stem cell transplantation
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.