AzTrials
AzTrials

Chronic Lymphocytic LeukemiaPhase 1NCT03913949

A Study to Evaluate the Safety,PK and PD of APG-2575 in Patients With Hematologic Malignancies

A Phase 1 study testing APG-2575 in people with Chronic Lymphocytic Leukemia and Non Hodgkin Lymphoma, run by Ascentage Pharma Group Inc. at 5 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic properties of APG-2575 in patients with relapse or refractory chronic lymphocytic leukemia and non-hodgkin's lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
APG-2575
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
5 sitesChina
Study dates
3 Jun 2019to 31 Dec 2026
Phase
Phase 1
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

  • Age ≥18 years old.
  • Histologically confirmed diagnosis of chronic lymphocytic leukemia, or non-Hodgkin's lymphoma such as mantle cell lymphoma, diffuse large B cell lymphoma, Waldenstrom macroglobulinemia (WM).
  • Patient must have relapsed or refractory to, intolerant to, or are considered ineligible for therapies known to provide clinical benefit.
  • Life expectancy ≥ 3 months.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose escalation; 0-2 in dose expansion.
  • Corrected QT interval ≤450ms in males, and ≤470ms in females.
Show all 19Show fewer
  • Adequate bone marrow function independent of growth factor:
  • Absolute neutrophil count (ANC) ≥1.0 X 10E9/L.
  • Hemoglobin ≥ 8.0 g/dL.
  • Platelets count ≥ 30 X 10E9/L (entry platelet count must be independent of transfusion within 7 days of first dose).
  • Adequate renal and liver function as indicated by:
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN); if serum creatinine is >1.5 X ULN, creatinine clearance must be ≥60 mL/min.
  • Total bilirubin ≤1.5 x ULN, except subject with known Gilbert's syndrome.
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <2.5 x ULN.
  • Alkaline phosphatase < 2.5 x ULN and < 5 x for bone metastases \&/or no hepatic parenchymal metastases on screening radiographic examination.
  • Thromboplastin time (aPTT)≤1.5 X ULN unless the subject is receiving anticoagulant therapy as long as prothrombin time (PT) or aPTT is within therapeutic range of intended use of anticoagulants.
  • Willingness by both males, and female patients of child bearing potential, to use contraception by a method that is deemed effective by the investigator, throughout the treatment period and for at least three months following the last dose of study drug Postmenopausal women must be amenorrheal for at least 12 months to be considered of non-childbearing potential. All partners must have the same willingness for contraception methods throughout the treatment period and for at least three months following the last dose of study drug as well.
  • 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:
  • Prior history of allogeneic cell transplant.
  • Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia.
  • Received chemotherapy within 14 days prior to entering the study.
  • Received biologic (< 28 days), small molecule targeted therapies (< 5 half-life) or other anti-cancer therapy within 21 days of study entry.
  • Concurrent treatment with an investigational agent, 14 days for small molecular agents and/or 28 days for biologics treatment prior to the first dose of therapy.
Show all 21Show fewer
  • Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry.
  • Has gastrointestinal conditions that could affect the absorption of APG-2575 in the opinion of the Investigator.
  • Has known active central nervous system (CNS) involvement.
  • Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy.
  • Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients with active wound healing, 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.
  • Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry.
  • Active rheumatoid arthritis (RA), active inflammatory bowel disease, or any other disease or condition associated with chronic inflammation.
  • Active infection requiring systemic antibiotic/ antifungal medication, known clinically active hepatitis B or C infection, or known HIV disease.
  • Known or suspected Wilson's Disease, or other conditions that affect copper accumulation or regulation.
  • Uncontrolled concurrent illness including, but not limited to: symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
  • The last treatment for the subject before signing the informed consent was bcl-2 targeted drug treatment (if the subject had received bcl-2 inhibitor treatment but did not develop drug resistance, it could be included in this study).
  • History of secondary active malignancies within the past 2 years. However, adequately treated superficial skin cancer other than melanoma, in-situ cervix cancer more than 4 weeks, or prostate cancer not requiring any treatment and under surveillance prior to enrollment will not be considered exclusionary.
  • Known to be allergic to study drug ingredients or their analogues.
  • Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of APG-2575.
  • Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • The First Affiliated Hospital, Zhejiang University School of Medicin

    Hangzhou, Zhejiang

  • Anhui Procincial hospital

    Hefei, Anhui

  • Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • Henan Provincial Oncology Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Properties of Orally Administered APG-2575 in Patients With Hematologic Malignancies

The purpose of this study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic properties of APG-2575 in patients with relapse or refractory chronic lymphocytic leukemia and non-hodgkin's lymphoma.

Read the detailed description

This is a multi-center, single-agent, open-label, Phase I study of APG-2575. The study consists of the dose escalation stage and the dose expansion stage. APG-2575 will be administered orally, once daily for consecutive 4 weeks as one cycle. Initially, the start dose is 20mg. Single patient cohorts will be evaluated, the dose of APG-2575 will be increased in subsequent cohorts, to 50 mg, 100 mg, 200 mg, 400 mg, 600mg and 800mg accordingly. If there is any one of the following event is observed, a dose-limiting toxicity (DLT), two drug related Grade 2 toxicities or one drug related ≥ Grade 3 toxicity, or laboratory or clinical tumor lysis syndrome (TLS), or suspected hypersensitivity reaction occur in Cycle 1, the dose escalation will convert to the standard 3+3 design, If ≥ 2/6 patients develop DLT at any dose level dose escalation will cease and the dose level immediately below will be expanded to 6 patients. If ≤ 1/6 patients develop a DLT at the highest dose reached this will be declared the MTD. After the MTD/Recommended Phase II Dose (RP2D) is defined, a maximum of 40 patients will be treated at that dose level.

Being tested
APG-2575
Keywords
APG-2575, B-cell lymphoma 2 (BCL-2), Chronic lymphocytic leukemia, non-hodgkin's lymphoma
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

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

  • APG-2575Drug

    Multiple dose cohorts, PO, every day (QD) of a 28-day cycle

Study groups in NCT03913949
Study groupRoleWhat they receive
single-agent, open-label, Phase I study of APG-2575ExperimentalThe study consists of the dose escalation stage and the dose expansion stage
Receives: Drug: APG-2575

What is being measured

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

  1. Maximum Tolerated Dose (MTD)

    Patients with APG-2575 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 5.0

    Measured: 28 days

Secondary outcomes (3)

  1. Maximum plasma concentration (Cmax)

    Maximum plasma concentration (Cmax) will be assessed in the patients treated with APG-2575

    Measured: 28 days

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

    Area under the plasma concentration versus time curve (AUC) of APG-2575 will be assessed in the patients treated with APG-2575

    Measured: 28 days

  3. Anti-tumor effects of APG-2575

    Response will be evaluated every 2 cycles (8 weeks), by the investigator based on disease specific criteria.

    Measured: up to 3 years

Timeline

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

  1. First posted12 Apr 2019
  2. Study start3 Jun 2019
  3. Primary completion20 Oct 2024
  4. Study completion31 Dec 2026 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03913949
Sponsor's protocol ID
APG-2575-CN-001
Status last verified
Apr 2026
First submitted
10 Apr 2019
Last updated
1 May 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 study testing APG-2575 in people with Chronic Lymphocytic Leukemia and Non Hodgkin Lymphoma, run by Ascentage Pharma Group Inc. at 5 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 19 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: 28 days). 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 NCT03913949.

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 1 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in