Chidamide, Venetoclax, Azacitidine, and Homoharringtonine for High-risk Fit AML (NCT07643636) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Chidamide, Venetoclax, Azacitidine, and Homoharringtonine for High-risk Fit AML
46 participantsStarted 2026-06-30
Plain-language summary
This study aims to explore a superior first-line induction remission regimen by incorporating Chidamide into the modified VAH chemotherapy combined with targeted therapy regimen, leveraging its dual epigenetic modulation mechanism.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Newly diagnosed fit-AML patients classified per the World Health Organization (WHO) classification criteria.
. Age ranging from 18 to 60 years, no restriction on gender.
. 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.
. Estimated overall survival ≥12 weeks.
. Eastern Cooperative Oncology Group (ECOG) performance status ≤3 points.
. Hepatic function: alanine aminotransferase (ALT) \<5× upper limit of normal (ULN); total bilirubin \<3× ULN.
. Able to provide written informed consent and understand as well as comply with all study-specified procedures.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines four drugs — chidamide, venetoclax, azacitidine, and homoharringtonine — which is a more intensive combination than some other regimens; can you help me understand what the side effect profile of combining all four of these might look like compared to standard options for high-risk AML?
2Since this is a Phase 2 trial, the researchers are still working to establish how well this combination works and confirm its safety — given that it hasn't reached Phase 3 yet, how does the current level of evidence compare to standard-of-care treatments you might recommend for me?
3The trial is listed as 'not yet recruiting,' so it isn't open to patients yet — do you know when it might open, and does waiting for this trial make sense given how quickly AML typically needs to be treated?
4The trial is specifically designed for 'high-risk fit' AML patients — can you help me understand whether my specific AML subtype, mutation profile, and overall health would likely meet that definition, and whether this trial would even be worth pursuing for my situation?
5The main goal of this trial is measuring composite complete remission rate, meaning CR and CRi combined — what does achieving a CRi rather than a full CR typically mean for long-term outcomes, and how does that goal compare to what standard treatment would aim for in my case?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.