New Triple-Drug strategy aims to boost remission in Hard-to-Treat leukemia
NCT ID NCT07712848
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether combining the targeted drug venetoclax with either a short course of decitabine or a modified DA regimen (daunorubicin and cytarabine) works better than the standard 3+7 DA regimen for adults newly diagnosed with acute myeloid leukemia. About 291 participants will be randomly assigned to one of three treatment groups. The study measures how many achieve complete remission after the first round of treatment, along with long-term survival and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- venetoclax combined with decitabine or daunorubicin and cytarabine
- What this could lead to
- If successful, this could identify a more effective and safer initial treatment for adults with acute myeloid leukemia, potentially improving remission rates and survival.
- What could go wrong
- This is an early-phase trial with a limited number of participants, so results may not apply to all patients. The treatments have significant side effects, including infection and bleeding risks.
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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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 291 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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Dec 2027
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 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: \- Subjects who are suitable for enrollment in this study must meet all of the following criteria: 1. Except for APL or carrying t(8) that meet the diagnostic criteria (WHO2022 criteria) of the World Health Organization; 21)/(RUNX1::RUNX1TI)、inv(16)(p13.1q22) 、 t(16; 16) (p13.1q22) 、 t(16; 16)/CBFβ::myh11) and other acute myeloid leukemia other than one of the abnormal karyotypes; 2. Except for acute panmyeloproliferative disease with myelofibrosis and myeloid sarcoma, the World Health Organization AML classification is AML without separate classification; 3. Newly diagnosed AML patients with male or female, age greater than or equal to 16 years old and less than 65 years old, patients are considered suitable for intensive chemotherapy; 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 at the time of enrollment; 5. The patient has not received previous AML therapy (except for hydroxyurea and Ara-C\<1.0g/d for reducing tumor compounds); 6. Pass the following laboratory test indicators (performed within 7 days before treatment): 1\) Aspartate aminotransferase (ALT), alanine aminotransferase (AST) and alkaline phosphatase (ALP) ≤3× upper limit of normal (ULN), serum bilirubin ≤2×ULN; Serum cardiac enzymes \< 2.0× ULN; Unless it is thought to be a leukemic organ involvement. Creatinine ≥ 30 mL/min, calculated by the Cockcroft Gault formula or measured by 24-hour urine collection; 7\. Female subjects of childbearing potential must have a negative pregnancy test result within 72 hours before the start of treatment; Not planning to become pregnant during the study and within 6 months after the last dose of study drug, and negative urine or serum pregnancy test results at screening. Men must use a latex condom during any sexual contact with WOCBP, even if they have had a successful vasectomy, and must agree to avoid childbearing (during treatment and for 6 months after the last dose of study drug). 8\. Life expectancy exceeds 2 months; 9\. Informed consent must be signed before the start of all specific study procedures, and the informed consent form must be signed by the patient or his immediate family; Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the legal guardian or the patient's immediate family will sign the informed consent form. Exclusion Criteria: * Subjects who meet any of the following criteria are not eligible for this study: 1. AML with BCR-ABL1; or CML sudden change period; 2. Treated patients (refers to those who have received induction chemotherapy in the past, regardless of the efficacy); 3. Subjects with acute panmyelopathy with myelofibrosis or myelosarcoma as defined by WHO 2016; 4. Secondary leukemia (mainly refers to those who belong to the treatment-related AML subcategory of the World Health Organization (WHO 2016) AML classification and those with a history of pre-stage MDS and/or MPD); 5. Patients with other hematological diseases (such as hemophilia, myelofibrosis, etc., who are not suitable for inclusion; Those with previous blood picture abnormalities, except for bone marrow examination, MDS and MPD are allowed to be selected); 6. Pregnant or lactating patients; 7. Those who are allergic to any drugs involved in this study; 8. Use of strong or moderate CYP7A inducers within 3 days before the start of study treatment; 9. Suffering from malignant tumors of other organs (those who need treatment); 10. Obvious abnormal liver and kidney function, exceeding the enrollment criteria; 11. Active cardiac disease, defined as one or more of the following: <!-- --> 1. Myocardial infarction less than 6 months from enrollment in the study; 2. History of arrhythmias requiring medication or severe clinical symptoms; 3. Uncontrolled or symptomatic congestive heart failure (\> NYHA Grade 2); 4. Uncontrolled or symptomatic angina; 5. Left ventricular ejection fraction below the lower limit of the normal range; 12\. Patients with severe infectious diseases (uncured tuberculosis, pulmonary aspergillosis), known infection with human immunodeficiency virus (HIV) or active hepatitis B or C; Subjects with uncontrollable infection. 13\. Subjects with evidence of central nervous system leukemia before treatment; 14\. Subjects with epilepsy, dementia or other abnormal mental states that require medication and cannot understand or follow the protocol; 15\. Restriction of oral drug intake or gastrointestinal absorption; 16\. Those who are not suitable for enrollment in the opinion of the investigator;
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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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The Second Affiliated Hospital of Kunming Medical University
RECRUITINGKunming, Yunnan, 650106, China
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