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Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML

NCT04501120 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 682

Last updated 2026-04-29

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, pharmacokinetic profile of Lisaftoclax (APG-2575) single agent and in combination with HHT/AZA in patients with relapsed/refractory AML and related myeloid malignancies.

Conditions

  • Relapsed/Refractory Acute Myeloid Leukaemia
  • Myeloid Malignancy

Interventions

DRUG

Lisaftoclax (APG-2575)

Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle.

DRUG

Reduced-dose HHT

1mg IV QD on Days 1-14 (28-day cycle).

DRUG

standard-dose HHT

2mg/m\^2 IV QD on Days 1-7 (28-day cycle).

DRUG

Azacitidine

75 mg/m\^2 SC or Iv gtt QD on Days 1- 7 (28-day cycle).

DRUG

Lisaftoclax (APG-2575)

Lisaftoclax (APG-2575) orally once daily for 14 days, every 28 days as a cycle.

DRUG

olverembatinib

orally, with meals, QOD, every 28 days as a cycle.

Sponsors & Collaborators

  • Suzhou Yasheng Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Yifan Zhai, M.D., Ph.D. · Suzhou Yasheng Pharmaceutical Co., Ltd.

  • Jie Jin, M.D. · the First Affiliated Hospital, College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2028-09-30
Completion
2029-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04501120 on ClinicalTrials.gov