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Lisaftoclax Regimens in Newly Diagnosed Intermediate- and High-Risk AML
NCT07651163Phase 3
Key facts
- Status
- Enrolling by invitation
- Start
- Mar 2026
- Primary completion
- Dec 2029
- Countries
- 1
- Sponsor
- First Affiliated Hospital, Zhejiang University School of Medicine
- Drugs
- lisaftoclax
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 3, randomised, open-label trial of lisaftoclax in acute myeloid leukemia (AML) (3 arms), sponsored by First Affiliated Hospital, Zhejiang University School of Medicine. Primary endpoint: Overall Survival at 2 years. Started Mar 2026; status: enrolling by invitation.
02
Design
3 arms- Study design
- RandomizedOpen-label
Arm A: Lisaftoclax+Daunorubicin+Cytarabine
Induction with LDA, consolidation with Lisaftoclax+Cytarabine, maintenance with Lisaftoclax+Azacitidine or Azacitidine alone.
Arm B: Lisaftoclax+homoharringtonine+cytarabine+aclarubicin
Induction with LHAA, consolidation with Lisaftoclax+Cytarabine, maintenance with Lisaftoclax+Azacitidine or Azacitidine alone.
Arm C: Lisaftoclax+azacitidine
Induction with LA, consolidation with Lisaftoclax+Cytarabine, maintenance with Lisaftoclax+Azacitidine or Azacitidine alone.
03
Who it enrols
Newly diagnosed intermediate- or adverse-risk AML patients aged 15-65 with ECOG 0-2, adequate organ function, and no prior BCL-2 inhibitors or HMAs.
04
Endpoints
Primary
Overall Survival
Secondary
Complete Response
Composite Complete Response
Minimal Residual Disease Negativity
Event-Free Survival
Relapse-Free Survival
Safety and Tolerability
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