Tests venetoclax with intensive chemotherapy in adults with acute myeloid leukemia
Tests venetoclax added to chemotherapy in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults and teenagers aged 14 to 60 with acute myeloid leukemia (AML) who have not been treated yet. It tests venetoclax added to intensive chemotherapy.
- Age
- 14 to 60 years
- Sex
- Men and women
- Disease stage
- Acute myeloid leukemia (AML) as defined by WHO 2022 or ICC standards, including MDS/AML. Daily-life fitness score (ECOG) of 0 to 2.
- Earlier treatment
- No earlier treatment for the leukemia. Hydroxyurea or cytarabine to lower the amount of leukemia is allowed.
- Biomarker or test result
- Blood tests within 7 days before treatment: bilirubin up to 1.5 times the upper limit of normal; AST and ALT up to 2.5 times; creatinine and heart enzymes under 2 times; heart ejection fraction above 50%.
Main reasons for not taking part
- Acute promyelocytic leukemia with the PML-RARA fusion gene
- Acute myeloid leukemia with the BCR-ABL fusion gene
- Another cancer that needs treatment
- Active heart disease, such as a heart attack in the last 6 months or heart failure above NYHA level 2
- Serious infection, such as untreated tuberculosis or lung aspergillosis
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 60 years old?
Source: NCT06635681, who can take part
Where in China
- Blood Diseases HospitalTianjin, ChinaContact: hui wei, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06635681
- Record updated
- 13 May 2026
- Original description
Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients.Read full original descriptionShow less
Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of Acute Myeloid Leukemia : a Multi-center, Single-arm Clinical Trial
Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients.
Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival.
Since AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy.
Therefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.
Inclusion: Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards; Age ≥14 years old, ≤ 60 years old, male or female; The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points; Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :; Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); AST and ALT≤ 2.5 times the upper limit of normal value (same age); Blood creatinine < 2 times the upper limit of normal (same age); Myocardial enzymes < 2 times the upper limit of normal (same age); Left ventricular ejection fraction \>50% by measure of echocardiogram (ECHO). Informed consent must be signed before the commencement of all specific study procedures, and signed by the patient himself or his immediate family. Considering the patient\'s condition, if the patient\'s signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient\'s immediate family.
Exclusion: Concurrent malignant tumors of other organs (those requiring treatment); Active heart disease, defined as one or more of the following:; A history of uncontrolled or symptomatic angina; Myocardial infarction less than 6 months after enrollment; Have a history of arrhythmia requiring drug treatment or severe clinical symptoms; Uncontrolled or symptomatic congestive heart failure (> NYHA level 2); Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis); Subjects who meet any of the following criteria are excluded from the study:; Acute promyelocytic leukemia with PML-RARA fusion gene; Acute myeloid leukemia with BCR-ABL fusion gene; Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden); Those who were not considered suitable for inclusion by the researchers.