New pill shows promise for Hard-to-Treat blood cancers
NCT ID NCT03913949
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Anhui Procincial hospital
Hefei, Anhui, China
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Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
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Henan Provincial Oncology Hospital
Zhengzhou, Henan, China
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The First Affiliated Hospital, Zhejiang University School of Medicin
Hangzhou, Zhejiang, China
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Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Double-Drug attack on Hard-to-Treat lymphomas
- Patient's own t cells engineered to hunt lymphoma in early trial
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Triple drug combo targets mantle cell lymphoma
- New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma
- Can AI spot the lymphoma patients who Won't respond?