New drug combo shows promise for AML patients
NCT ID NCT05471700
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a combination of two drugs, azacitidine and venetoclax, in 40 adults aged 45 to 65 with newly diagnosed acute myeloid leukemia (AML). The goal was to see how safe and effective the combo is at shrinking the cancer. Participants received the drugs in 28-day cycles, and researchers measured how many achieved remission.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- azacitidine and venetoclax
- What this could lead to
- If successful, this combination could offer a new treatment option for acute myeloid leukemia, potentially improving remission rates.
- What could go wrong
- This is a small, single-arm study with no comparison group, so results may not be definitive. Side effects from the drugs are possible.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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40 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Apr 2023
- 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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45 to 65 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: * 1.Age 45 to 65 years old,both male and female * 2.Be able to understand and sign informed consent * 3.Untreated AML patients (non-APL) diagnosed according to the 2016 World Health Organization (WHO) classification and diagnostic criteria for acute myeloid leukemia * 4.Patients with an ECOG performance status 0,1,2 or 3 * 5.Expected survival time≥3 months * 6.Laboratory indicators meet the following standards: 1. Bilrubin, ALT and AST were all less than 3 times the upper limit of normal within 7 days before the first day of treatment 2. Serum creatinine clearance rate is greater than 30ml/min Exclusion Criteria: * 1.patients participating in other interventional or observational clinical studies currently * 2.Patients has a history of myeloproliferative neoplasm \[MPN\] * 3.Patients with acute promyelocytic leukemia * 4.Active CNS involvement in patients with acute myeloid leukemia * 5.Patients with active hepatitis B or C, HIV infection before enrollment * 6.Cardiovascular status of patients evaluate by NYHA classification method \> 2 * 7.Patients have chronic respiratory disease requiring continuous oxygen treatment, or any sitiuation investigator believes will adversely affect this study (including renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular disease and known history of allergy to any study drug) * 8.Patients suffering from malabsorption syndrome or other diseases that prevent the enteral route of administration * 9.patients present with an uncontrolled systemic infection (viral, bacterial, or fungal) * 10.Patients with a history of other malignancies within 2 years before enrollment, except for the following cases: 1. Adequately treated carcinoma in situ of the cervix or carcinoma of the breast 2. Basal cell carcinoma or localized squamous cell carcinoma of skin
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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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Nanfang Hospital of Southern Medical University
Guanzhou, Guandong, 510250, China
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