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Selinexor with HAD or CAG in Relapsed/Refractory AML
NCT05726110Phase 3
Key facts
- Status
- Recruiting
- Start
- Jan 2023
- Primary completion
- Dec 2024
- Countries
- 1
- Sponsor
- Shanxi Bethune Hospital
- Modality
- Small Molecules
- Drugs
- selinexor
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 3, open-label, single-arm trial of selinexor in acute myeloid leukemia (AML), sponsored by Shanxi Bethune Hospital. Primary endpoint: Remission Rate (CR, PR, NR, CRi) at 2 years. Started Jan 2023; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Selinexor + HAD or CAG
Selinexor combined with either HAD (Homoharringtonine, Daunorubicin, Cytarabine) or CAG (G-CSF, Aclarubicin, Cytarabine) regimen.
03
Who it enrols
Patients aged 18-60 with relapsed or refractory AML (excluding M3), ECOG 0-2, and adequate organ function. Excludes patients with cerebral hemorrhage, severe arrhythmia (QT>500ms), or pregnancy.
04
Endpoints
Primary
Remission Rate (CR, PR, NR, CRi)
Secondary
Recurrence Rate
Treatment-Related Mortality
Overall Survival
Event-Free Survival
Incidence and severity of adverse events
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