RecruitingPhase 1Phase 2NCT04501120

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

A Phase Ib Study of the Safety, Pharmacokinetic of Lisaftoclax (APG-2575) Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With Relapsed/Refractory AML


Sponsor

Ascentage Pharma Group Inc.

Enrollment

682 participants

Start Date

Sep 28, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests lisaftoclax (APG-2575), a drug that blocks a protein that helps cancer cells avoid dying, for people with relapsed or hard-to-treat leukemia and related blood cancers. It is testing the drug alone and in combination with other treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with relapsed or refractory acute myeloid leukemia (AML), or a related blood cancer such as myelodysplastic syndrome (MDS), CMML, or mixed-phenotype leukemia - You have measurable disease and are in adequate overall health - You have received prior treatment that is no longer working **You may NOT be eligible if...** - You have active central nervous system (brain) involvement of your leukemia - You have uncontrolled infections - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLisaftoclax (APG-2575)

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

DRUGReduced-dose HHT

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

DRUGstandard-dose HHT

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

DRUGAzacitidine

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

DRUGLisaftoclax (APG-2575)

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

DRUGolverembatinib

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


Locations(12)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guandong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Henan Tumor Hospital

Zhengzhou, Henan, China

Union Hospital medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

Zhongnan Hospital of Hunan university

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

The First affiliated hospital of Soochow University

Suzhou, Jiangsu, China

Shanghai The Sixth People' s Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

the First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT04501120


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