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Relapsed/Refractory Acute Myeloid LeukaemiaPhase 1/2NCT04501120

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

A Phase 1/2 study testing Lisaftoclax (APG-2575), Reduced-dose HHT and standard-dose HHT in people with Relapsed/Refractory Acute Myeloid Leukaemia and Myeloid Malignancy, run by Ascentage Pharma Group Inc. at 12 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lisaftoclax (APG-2575), Reduced-dose HHT and standard-dose HHT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
682 participants
Where
12 sitesChina
Study dates
28 Sep 2020to Sep 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who meet each of the following inclusion criteria are eligible to participate in this study:
  • In accordance with the World Health Organization (WHO) 2016 diagnostic criteria for relapsed or refractory acute myeloid leukemia (AML), Mixed phenotype acute leukemia(MPAL), Chronic myelomonocytic leukemia (CMML), Higher-risk myelodysplastic syndrome (HR-MDS) , Blastic plasmacytoid dendritic cell neoplasm (BPDCN) and naïve AML ineligible for treatment with a standard chemotherapy due to age or comorbidities.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2 (0 to 3 for participants >= 60 to 74 years of age who are evaluated as ineligible for treatment with standard chemotherapy).
  • Subjects can accept oral administration of Lisaftoclax (APG-2575).
  • Life expectancy ≥ 3 months.
  • Adequate renal and liver function.
Show all 9Show fewer
  • Males, female patients of childbearing potential (postmenopausal women who must have been menopausal for at least 12 months to be considered infertile) and their partners voluntarily take contraception which the investigator considers effective during treatment and at least three months after the last dose of study drug.
  • Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).
  • Willingness and ability to comply with study procedures and follow-up examination.

Who cannot join

  • Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
  • Patients diagnosed with acute promyelocytic leukemia or t(9;22)(q34.1;q11.2); BCR-ABL1 positive AML patients.
  • The persistent toxicities caused by previous chemotherapy or radiotherapy has not been restored to lower than grade 2 by CTCAE 5.0 (except for alopecia).
  • Known leukemia infiltration of the central nervous system.
  • Symptomatic active fungal, bacterial and/or viral infections.
  • Prior history of allogeneic hematopoietic stem cell transplantation or adoptive cell immunotherapy, autologous hematopoietic stem cell transplantation within 12 months.
Show all 10Show fewer
  • Within 14 days before the first dose of study drug, received chemotherapy (hydroxyurea is permitted more than 24 hours before the first dose of study drug), radiotherapy, surgery, immunotherapy, targeted therapy, biological therapy or any investigational treatment.
  • Within 7 days before the first dose of study drug, received a strong and/or moderate CYP3A inducer and/or Inhibitor.
  • At the discretion of the investigator, gastrointestinal diseases that affect the absorption of Lisaftoclax (APG-2575).
  • Any other condition or circumstance, at the discretion of the investigator, that patients would be unsuitable for participation in the study.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jie Jin, M.D. contact

+86 571-87236896

jiej0503@163.com

12 sites in 1 country

China12 sites, 12 recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Qiang Jiang, Professor

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan

    Yajing Xu, Master

    Qun He, Master

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044

    Xiao Shuai, M.D., 18980606797, 5397781@qq.com

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality

    Yi Gong, M.D.

    Not yet recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guandong

    Yang Liang, Professor

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Jianyu Wong, M.D.

    Recruiting

  • the First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

    Jie Jin, M.D., +86 571-87236896, jiej0503@163.com

    Recruiting

  • Shanghai The Sixth People' s Hospital

    Shanghai, Shanghai Municipality

    Chunkang Chang, Professor

    Not yet recruiting

  • The First affiliated hospital of Soochow University

    Suzhou, Jiangsu

    Suning Chen, M.D.

    Recruiting

  • Union Hospital medical college Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Qiubo Li, Professor

    Recruiting

  • Zhongnan Hospital of Hunan university

    Wuhan, Hubei, 430071

    Fuling Zhou, Professor

    Jianying Zhou, Professor

    Recruiting

  • Henan Tumor Hospital

    Zhengzhou, Henan

    Xudong Wei, Professor

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

This is an open-label, multi-center Phase Ib study of safety, PK of Lisaftoclax (APG-2575) as single agent or in combination with HHT or AZA in relapsed/refractory AML and related myeloid malignancies patients.

This study consists of three stages: The first stage is the Lisaftoclax (APG-2575) single agent dose-escalation study. The second stage is the Lisaftoclax (APG-2575) combined with HHT/AZA dose-escalation study. The third stage is the MTD/RP2D expansion cohort study of the combination regimen.

Being tested
Lisaftoclax (APG-2575), Reduced-dose HHT, standard-dose HHT, Azacitidine, olverembatinib
Keywords
Acute Myeloid Leukaemia (AML), Bcl-2 Inhibitor, Myeloid Malignancy, Lisaftoclax (APG-2575)
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lisaftoclax (APG-2575)Drug

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

  • Reduced-dose HHTDrug

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

  • standard-dose HHTDrug

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

  • AzacitidineDrug

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

  • Lisaftoclax (APG-2575)Drug

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

  • olverembatinibDrug

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

Study groups in NCT04501120
Study groupRoleWhat they receive
Lisaftoclax (APG-2575) single agentExperimentalLisaftoclax (APG-2575) orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg, to determine the MTD/RP2D.
Receives: Drug: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575)+reduced-dose HHTExperimentalLisaftoclax (APG-2575) MTD/RP2D-1 and MTD/RP2D combines with reduced-dose HHT in R/R AML, MPAL, BPDCN, CMML.
Receives: Drug: Lisaftoclax (APG-2575); Drug: Reduced-dose HHT
Lisaftoclax (APG-2575)+ standard-dose HHTExperimentalLisaftoclax (APG-2575) MTD/RP2D-1 and MTD/RP2D combines with standard-dose HHT in R/R AML, MPAL, BPDCN, CMML.
Receives: Drug: Lisaftoclax (APG-2575); Drug: standard-dose HHT
Lisaftoclax (APG-2575)+ AZAExperimentalLisaftoclax (APG-2575) MTD/RP2D-1 and MTD/RP2D combines with AZA in R/R AML, MPAL, BPDCN, CMML.
Receives: Drug: Lisaftoclax (APG-2575); Drug: Azacitidine
Lisaftoclax (APG-2575)+ AZA(HR-MDS.)ExperimentalLisaftoclax (APG-2575) MTD/RP2D-1 and MTD/RP2D combines with AZA in HR-MDS.
Receives: Drug: Azacitidine; Drug: Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575)+ AZA(Naïve AML.)ExperimentalLisaftoclax (APG-2575) MTD/RP2D-1 and MTD/RP2D combines with AZA in treatment naïve AML.
Receives: Drug: Lisaftoclax (APG-2575); Drug: Azacitidine
Lisaftoclax (APG-2575)+AZA+OlverembatinibExperimentalLisaftoclax (APG-2575) combines with AZA and Olverembatinib in R/R AML.
Receives: Drug: Azacitidine; Drug: Lisaftoclax (APG-2575); Drug: olverembatinib
Lisaftoclax (APG-2575)+HHT+OlverembatinibExperimentalLisaftoclax (APG-2575) combines with HHT and Olverembatinib in R/R AML.
Receives: Drug: standard-dose HHT; Drug: Lisaftoclax (APG-2575); Drug: olverembatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities (DLT)

    DLT will be graded according to NCI CTCAE Version 5.0. DLT will be defined as clinically significant drug-related adverse events during cycle one.

    Measured: 28 days

  2. Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose(RP2D)

    MTD/RP2D will be determined based on DLTs observed during cycle one.

    Measured: 28 days

Secondary outcomes (6)

  1. Maximum plasma concentration (Cmax)

    Cmax of Lisaftoclax (APG-2575) will be assessed in the patients in single agent or combo study.

    Measured: 28 days

  2. Area under the plasma concentration versus time curve (AUC)

    AUC of Lisaftoclax (APG-2575) will be assessed in the patients in single agent or combo study.

    Measured: 28 days

  3. Objective Response Rate (ORR)

    ORR is defined by CR+ CRi + PR(according to IWG AML(2003)).Response will be evaluated on cycle 1 and every even cycles till completing 6 cycles treatment or end of treatment.

    Measured: Up to 6 cycles (each cycle is 28 days).

  4. progression free survival (PFS)

    From date of treatment start until the date of progression or the date of death due to any cause.

    Measured: Up to 2 years.

  5. duration of response (DOR)

    From date of response until the date of progression.

    Measured: Up to 2 years.

  6. overall survival (OS)

    From date of treatment start until the date of death due to any cause.

    Measured: Up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start28 Sep 2020
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
682 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04501120
Sponsor's protocol ID
APG2575AC101
Status last verified
Apr 2026
First submitted
3 Aug 2020
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lisaftoclax (APG-2575), Reduced-dose HHT and standard-dose HHT in people with Relapsed/Refractory Acute Myeloid Leukaemia and Myeloid Malignancy, run by Ascentage Pharma Group Inc. at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jie Jin, M.D. (+86 571-87236896, jiej0503@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLT) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04501120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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