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New hope for tough leukemia: experimental drug combo enters human testing

NCT ID NCT04501120

Disease control Sponsor: Ascentage Pharma Group Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called lisaftoclax, alone or combined with other medicines, in people with acute myeloid leukemia that has come back or not responded to treatment. The main goals are to check safety and find the best dose. About 682 adults will take part across multiple groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lisaftoclax (APG-2575), homoharringtonine, azacitidine, olverembatinib
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-treat acute myeloid leukemia.
What could go wrong
This is an early-phase trial (Phase 1b/2) focused on safety and dosing, so it is too soon to know if the drug combination will be effective. Side effects are possible, and the results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 682 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subjects who meet each of the following inclusion criteria are eligible to participate in this study: 1. 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. 2. 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). 3. Subjects can accept oral administration of Lisaftoclax (APG-2575). 4. Life expectancy ≥ 3 months. 5. Adequate renal and liver function. 6. 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. 7. 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). 8. Willingness and ability to comply with study procedures and follow-up examination. Exclusion Criteria: Patients who meet any of the following exclusion criteria are not to be enrolled in this study: 1. Patients diagnosed with acute promyelocytic leukemia or t(9;22)(q34.1;q11.2); BCR-ABL1 positive AML patients. 2. 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). 3. Known leukemia infiltration of the central nervous system. 4. Symptomatic active fungal, bacterial and/or viral infections. 5. Prior history of allogeneic hematopoietic stem cell transplantation or adoptive cell immunotherapy, autologous hematopoietic stem cell transplantation within 12 months. 6. 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. 7. Within 7 days before the first dose of study drug, received a strong and/or moderate CYP3A inducer and/or Inhibitor. 8. At the discretion of the investigator, gastrointestinal diseases that affect the absorption of Lisaftoclax (APG-2575). 9. Any other condition or circumstance, at the discretion of the investigator, that patients would be unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia CD4+/CD56+ hematodermic neoplasm chronic myelomonocytic leukemia mixed phenotype acute leukemia myelodysplastic syndrome myeloid neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myeloid malignancy Relapsed/refractory acute myeloid leukaemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chongqing University Cancer Hospital

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Henan Tumor Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Shanghai The Sixth People' s Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guandong, China

  • The First affiliated hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, China

  • Union Hospital medical college Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610044, China

  • Xiangya Hospital Central South University

    RECRUITING

    Changsha, Hunan, China

  • Zhongnan Hospital of Hunan university

    RECRUITING

    Wuhan, Hubei, 430071, China

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

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

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