New triple-drug attack aims to wipe out stubborn leukemia
NCT ID NCT07563179
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs (bugitinib, venetoclax, and cytarabine) in adults with acute myeloid leukemia that has come back or not responded to treatment. The goal is to see if the treatment can clear hidden cancer cells from the bone marrow and keep them away. About 10 participants will receive the drugs in cycles, with adjustments if needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 70 years
- 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: Participants must meet all of the following criteria: * Age 18-70 years (inclusive), regardless of sex; * Diagnosis of non-M3 acute myeloid leukemia (AML), and meeting at least one of the following conditions: * Failure to achieve complete remission (CR) after standard induction chemotherapy; * First CR duration ≤12 months; * First CR duration \>12 months, followed by relapse and failure of at least one line of standard chemotherapy; * Relapsed disease after ≥2 prior lines of therapy; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; * Estimated life expectancy ≥3 months; * Adequate organ function, defined as: * Cardiac: left ventricular ejection fraction (LVEF) ≥50% by echocardiography, with no clinically significant ECG abnormalities; * Renal: serum creatinine ≤2.0 × upper limit of normal (ULN) and creatinine clearance ≥60 mL/min (Cockcroft-Gault); * Hepatic: ALT and AST ≤3.0 × ULN; * Total bilirubin ≤2.0 × ULN (≤3.0 × ULN for patients with Gilbert syndrome); * Oxygen saturation ≥92% on room air; * Ability to take oral medications and comply with study procedures; * Willingness to participate and provide written informed consent. Exclusion Criteria: Participants meeting any of the following criteria will be excluded: * Known hypersensitivity to any study drug or its excipients; * Active central nervous system (CNS) leukemia (patients with prior CNS involvement who achieved complete remission and are clinically stable may be eligible); * Active, uncontrolled bacterial, viral, or systemic fungal infection; * Known hereditary bleeding or coagulation disorders, history of non-traumatic bleeding or thromboembolism, or other conditions that may increase bleeding risk; * Evidence of active infection, including: * Hepatitis B virus (HBV) infection with positive HBsAg or HBcAb and HBV DNA \>100 copies/mL; * Hepatitis C virus (HCV) antibody positive with detectable HCV RNA; * Human immunodeficiency virus (HIV) infection; * Positive test for syphilis; * Active bleeding or clinically significant bleeding tendency, including but not limited to: * Active gastrointestinal bleeding, intracranial hemorrhage, or bleeding in other vital organs; * Grade ≥3 bleeding event within 4 weeks prior to enrollment (per CTCAE); * Known hereditary bleeding disorders (e.g., hemophilia); * Severe platelet dysfunction not correctable; * Significant cardiovascular disease, including but not limited to: * New York Heart Association (NYHA) class III-IV heart failure; * Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment; * Clinically significant ventricular arrhythmias or unexplained syncope (excluding vasovagal or dehydration-related causes); * Severe cardiomyopathy; * History of or concurrent other malignancies (except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix); * Clinically significant central nervous system disorders (e.g., epilepsy, stroke, psychiatric disorders) that may affect compliance or safety; * Participation in another interventional clinical trial within 30 days prior to enrollment; * Pregnant or breastfeeding women, or subjects planning pregnancy during the study period or within 6 months after the last dose and unwilling to use effective contraception; * Known or suspected drug abuse or alcohol dependence; * Requirement for concomitant use of strong CYP3A inhibitors or inducers that cannot be discontinued or dose-adjusted per protocol; * Any other condition that, in the investigator's opinion, would make the subject unsuitable for participation.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Shenzhen University general hospital
RECRUITINGShenzhen, Guangdong, 0755, China
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Other studies related to the condition(s) this trial covers.
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- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?
- New drug combination targets Hard-to-Treat blood cancers