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New pill shows promise for Hard-to-Treat blood cancers

NCT ID NCT03913949

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing an experimental oral drug called APG-2575 in people with relapsed or refractory chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). The main goal is to check the drug's safety and find the best dose. About 74 participants will take the drug daily in 28-day cycles. This is a Phase 1 study, so it is primarily looking at safety and how the body processes the drug, not yet whether it works.

What this could mean

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

Active substance
APG-2575 (an experimental oral drug)
What this could lead to
If successful, this could lead to a new treatment option for people with certain blood cancers that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 74 participants, focused on safety and dosing. The drug may not prove effective or could have side effects.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 74 people

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

Started

Jun 2019

Expected to finish

Dec 2026

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: 1. Age ≥18 years old. 2. 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). 3. Patient must have relapsed or refractory to, intolerant to, or are considered ineligible for therapies known to provide clinical benefit. 4. Life expectancy ≥ 3 months. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose escalation; 0-2 in dose expansion. 6. Corrected QT interval ≤450ms in males, and ≤470ms in females. 7. Adequate bone marrow function independent of growth factor: 1. Absolute neutrophil count (ANC) ≥1.0 X 10E9/L. 2. Hemoglobin ≥ 8.0 g/dL. 3. Platelets count ≥ 30 X 10E9/L (entry platelet count must be independent of transfusion within 7 days of first dose). 8. Adequate renal and liver function as indicated by: 1. 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. 2. Total bilirubin ≤1.5 x ULN, except subject with known Gilbert's syndrome. 3. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \<2.5 x ULN. 4. Alkaline phosphatase \< 2.5 x ULN and \< 5 x for bone metastases \&/or no hepatic parenchymal metastases on screening radiographic examination. 5. 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. 9. 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. 10. 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). 11. 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. Prior history of allogeneic cell transplant. 2. Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia. 3. Received chemotherapy within 14 days prior to entering the study. 4. Received biologic (\< 28 days), small molecule targeted therapies (\< 5 half-life) or other anti-cancer therapy within 21 days of study entry. 5. 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. 6. Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry. 7. Has gastrointestinal conditions that could affect the absorption of APG-2575 in the opinion of the Investigator. 8. Has known active central nervous system (CNS) involvement. 9. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not recover to ≤ Grade 1 except alopecia or neuropathy. 10. 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. 11. Unstable angina, myocardial infarction, or a coronary revascularization procedure within 180 days of study entry. 12. Active rheumatoid arthritis (RA), active inflammatory bowel disease, or any other disease or condition associated with chronic inflammation. 13. Active infection requiring systemic antibiotic/ antifungal medication, known clinically active hepatitis B or C infection, or known HIV disease. 14. Known or suspected Wilson's Disease, or other conditions that affect copper accumulation or regulation. 15. 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. 16. 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). 17. 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. 18. Known to be allergic to study drug ingredients or their analogues. 19. Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of APG-2575. 20. Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Anhui Procincial hospital

    Hefei, Anhui, China

  • Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020, China

  • Henan Provincial Oncology Hospital

    Zhengzhou, Henan, China

  • The First Affiliated Hospital, Zhejiang University School of Medicin

    Hangzhou, Zhejiang, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, China

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Other studies related to the condition(s) this trial covers.