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Chronic Lymphocytic LeukemiaPhase 2NCT05147467

Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL

A Phase 2 study testing APG2575 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Ascentage Pharma Group Inc. at 11 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
Search all trials

Trial summary

The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
APG2575
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
11 sitesChina
Study dates
28 Dec 2021to Dec 2027
Phase
Phase 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:
  • Age ≥18 years old.
  • Pathologically confirmed CLL/SLL according to the 2018 revised IWCLL NCI-WG guidelines, subject with measurable lesions or splenomegaly due to CLL.
  • Expected survival is at least 12 weeks.
  • Refractory, recurrent, or intolerant to BTK inhibitors and immunochemotherapy,or first-line treatment with BTK inhibitors fails and is not suitable for immunochemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2.
  • Ability to understand and willingness to sign a written informed consent form approved by EC committee (the consent form must be signed by the patient prior to any screening or study-specific procedures).
  • Willingness and ability to comply with study procedures and follow-up examination.

Who cannot join

  • Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
  • Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy or autologous hematopoietic stem cell transplantation within 24 months.
  • Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
  • Received Bcl-2 inhibitor treatment.
  • Invasive NHL transformation or central nervous system (CNS) involvement has occurred.
  • Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
Show all 11Show fewer
  • Within 2 years before entering the study, the subject had a history of active malignant tumors other than CLL / SLL, except that:
  • Fully treated cervical carcinoma in situ;
  • Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
  • Confinement and resection of previously cured malignancies (or other treatment).
  • Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.

Trial locations and contacts

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

Zi Chen, Doctor contact

+8618117275173

Zi.Chen@ascentage.com

Min Yu, Doctor contact

+8615000679101

Min.Yu@ascentage.com

11 sites in 1 country

China11 sites, 11 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Yang Liang, Postdoc

    Yang Liang, Postdoc

    Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Rui Huang, M.D., Ph.D.

    Rui Huang, M.D., Ph.D.

    Not yet recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

    Ru Feng

    Ru Feng, M.D.

    Recruiting

  • Hainan General Hospital

    Haikou, Hainan, 570311

    Li'e Lin, M.D.

    Li'e Lin, M.D.

    Not yet recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hanzhou, Zhejiang, 310003

    Jie Jin, M.D., Ph.D.

    Jie Jin, M.D., Ph.D.

    Not yet recruiting

  • The First Affilated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Fei Li, M.D., Ph.D.

    Fei Li, M.D., Ph.D.

    Not yet recruiting

  • The First Affilated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Caixia Li, M.D., Ph.D.

    Caixia Li, M.D., Ph.D.

    Not yet recruiting

  • People's hospital of Jiangsu Province

    Suzhou, Jiangsu

    Jianyong Li, M.D., lijianyonglm@medmail.com.cn

    Jianyong Li, M.D.

    Not yet recruiting

  • Institute of blood transfusion of Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 215127

    Tingyu Wang, M.D., Ph.D.

    Tingyu Wang, M.D., Ph.D.

    Not yet recruiting

  • Union Hospital medical college Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Guohui Cui, M.D.

    Guohui Cui, M.D.

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Keshu Zhou, M.D., Ph.D.

    Keshu Zhou, M.D., Ph.D.

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Pivotal Registration Phase II Study of the Efficacy and Safety of APG-2575 Monotherapy in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL.

Read the detailed description

This is an single-arm, open-label, multi-center, pivotal registration Phase II study of efficacy and safety of APG-2575 as a single agent in relapsed/refractory CLL/SLL patients.

This study plans to enroll approximately 75 CLL/SLL subjects who have failed or are intolerant to prior immunochemotherapy and BTK inhibitor therapy. Eligible subjects will receive APG-2575 600mg, orally administered once daily (QD), within half an hour of a low-fat meal, for a cycle of 28 days. Participants will continue to accept APG - 2575 until the "end of treatment" that are consistent with the provisions in the solution of the termination of any specified standards.

Being tested
APG2575
Keywords
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, APG-2575, Lisaftoclax
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • APG2575Drug

    APG-2575 orally once daily at 600mg dose levels, every 28 days as a cycle.

Study groups in NCT05147467
Study groupRoleWhat they receive
APG-2575 single agent in Relapse/Refractory CLL/SLLExperimentalAPG-2575 orally once daily at 600mg dose levels, every 28 days as a cycle.
Receives: Drug: APG2575

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR is defined by Complete Remission (CR)+ CR with incomplete marrow recovery (CRi) + Partial Remission (PR) (according to NCI-WG CLL(2018)) and by CR+PR ( according to Lugano (2014)).Response will be evaluated every 2 cycles (8 weeks) till complete treatment or one month after last dose.

    Measured: Up to 9 months after the last subject enrolled.

Secondary outcomes (9)

  1. Progress Free Survival (PFS)

    PFS is defined as the time from the first administration to disease progression(PD) or death from any cause.

    Measured: Up to 9 months after the last subject enrolled.

  2. Time To Progression (TTP)

    TTP is defined as the time from the first administration to PD.

    Measured: Up to 9 months after the last subject enrolled.

  3. Time To Response (TTR)

    TTR is defined as the time from the first administration to the subjects' first CR, CRi, or PR.

    Measured: Up to 9 months after the last subject enrolled.

  4. Duration of Response (DOR)

    DOR is defined as the time from the subject's first CR, CRi, or PR to PD or death from any cause.

    Measured: Up to 9 months after the last subject enrolled.

  5. Overall Survival (OS)

    OS is defined as the time from the first administration to death.

    Measured: Up to 9 months after the last subject enrolled.

  6. the time of half absolute lymphocyte value (ALC)

    The time of half absolute lymphocyte value (ALC) is defined as the time from the first administration to 50% reduction of ALC of baseline.

    Measured: Up to 9 months after the last subject enrolled.

  7. Adverse events

    Adverse events (AE) and serious adverse events (SAE) will be graded according to NCI CTCAE Version 5.0.

    Measured: Up to 9 months after the last subject enrolled.

  8. Maximum plasma concentration (Cmax)

    Maximum plasma concentration (Cmax) will be assessed on all participants with APG-2575 treatments.

    Measured: Up to 4 cycles (each cycle is 28 days).

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

    Area under the plasma concentration versus time curve (AUC) will be assessed on all participants with APG-2575 treatments.

    Measured: Up to 4 cycles (each cycle is 28 days).

Timeline

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

  1. First posted7 Dec 2021
  2. Study start28 Dec 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05147467
Sponsor's protocol ID
APG2575CC201
Status last verified
Mar 2026
First submitted
24 Nov 2021
Last updated
27 Mar 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 2 study testing APG2575 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Ascentage Pharma Group Inc. at 11 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 8 inclusion and 11 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 phase mean?

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 Zi Chen, Doctor (+8618117275173, Zi.Chen@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 9 months after the last subject enrolled.). 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 NCT05147467.

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 27 Mar 2026.

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