New drug cocktail aims to boost remission in tough AML cases
NCT ID NCT07643636
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new combination of drugs (chidamide, venetoclax, azacitidine, and homoharringtonine) as a first treatment for adults aged 18-60 with intermediate- to high-risk acute myeloid leukemia (AML). The goal is to see if this mix can improve remission rates and reduce the chance of the cancer coming back. About 46 participants will receive the treatment and be followed for up to 2 years.
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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 46 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 60 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Newly diagnosed fit-AML patients classified per the World Health Organization (WHO) classification criteria. 2. Age ranging from 18 to 60 years, no restriction on gender. 3. No prior anti-AML systemic therapy after AML diagnosis; cytoreductive treatment (e.g., hydroxyurea or cytarabine at a daily dose \<1.0 g) is permitted as exception. 4. Estimated overall survival ≥12 weeks. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤3 points. 6. Renal function: calculated creatinine clearance (CrCl) ≥30 mL/min. 7. Hepatic function: alanine aminotransferase (ALT) \<5× upper limit of normal (ULN); total bilirubin \<3× ULN. 8. Able to provide written informed consent and understand as well as comply with all study-specified procedures. Exclusion Criteria: 1. Patients stratified as favorable-risk AML defined by NCCN Guidelines 2022, including cytogenetic aberrations: t(8;21)(q22;q22.1); RUNX1-RUNX1T1, inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11. 2. Confirmed acute promyelocytic leukemia (APL). AML complicated with central nervous system (CNS) leukemia infiltration. 3. Cardiac function exceeding NYHA functional class II. 4. Confirmed human immunodeficiency virus (HIV) infection or other uncontrolled clinically significant comorbidities, including but not limited to: * Uncontrolled or active systemic infection (viral, bacterial or fungal); ② Concurrent second primary malignancy requiring urgent clinical intervention. 6\. Patients unable to receive oral chidamide and/or venetoclax administration. 7. Known hypersensitivity to any investigational product. 8. Pregnant or breastfeeding female subjects. 9. Inability to understand or adhere to the study protocol requirements. 10.Subjects deemed unsuitable for enrollment at the investigator's discretion
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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 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
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