Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML (NCT05654194) | Clinical Trial Compass
CompletedPhase 3
Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML
China60 participantsStarted 2022-10-31
Plain-language summary
This is a single arm study to evaluate the safety and efficiency of azacitidine (AZA) combination with venetoclax and ATRA in Patients With Newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax and ATRA, may stop the growth of cancer cells, either by demethylation, by promoting cells differentiation or by killing the cells.
Who can participate
Age range
18 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 AML according to the WHO (2016) classification of acute myeloid leukemia.
* Age ≥ 18years.
* ECOG score: 0-3.
* White blood cell count ≤ 25\*10\^9/L
* Total bilirubin ≤ 3X the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic disease
* AST (SGOT) and ALT (SGPT) ≤ 3X the institutional upper limit of normal
* Creatinine clearance ≥30ml/min
Exclusion Criteria:
* Pregnancy or lactation.
* Acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
* Another malignant disease.
* Uncontrolled active infection.
* Left ventricular ejection fraction \< 0.3 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
* Active hepatitis B or hepatitis C infection.
* HIV infection.
* Other commodities that the investigators considered not suitable for the enrollment.
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 combined three drugs — azacitidine, venetoclax, and ATRA — for newly diagnosed AML; can you explain why adding ATRA to the azacitidine and venetoclax combination might matter for my specific type of AML, and whether my disease would have been similar to what this trial studied?
2Since this is a completed Phase 3 trial measuring bone marrow complete response rates, has any results data been published yet, and what did it show about how well this three-drug combination actually worked?
3How does the bone marrow complete response rate from this trial compare to what I might expect from the standard treatments you're already considering for me?
4A trial like this likely had strict eligibility criteria for newly diagnosed AML patients — are there reasons based on my diagnosis, age, or health profile that would make this combination approach more or less suitable for me?
5If the results from this completed trial look promising, is this three-drug combination something you could offer me now as part of my treatment plan, or would I need to wait for it to become a standard approved regimen?
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.
What they're measuring
1
Rate of the bone marrow complete response
Timeframe: after completion of one induction courses (1st Induction Course is 28 days) and before starting of the 2nd cycle
Trial details
NCT IDNCT05654194
SponsorThe First Affiliated Hospital of Soochow University