Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2024-09-29
Last updated
2026-05-13
Condition(s) studied
AML (Acute Myelogenous Leukemia)
Investigational drug(s) / intervention(s)
DaunorubicinCytarabineVenetoclaxAzacitidine
Daunorubicin: 60mg/m2/d d1-3 in Induction therapy
Cytarabine: Cytarabine 100mg/m2/d d1-7 in Induction therapy, 2g/m2 q12h d1-3 in Consolidation therapy
Venetoclax: 100mg d-2, 200mg d-1, 400mg d1-7 in Induction therapy, 400mg d1-7 in Consolidation therapy and Maintenance treatment
Azacitidine: 75mg/m2/d d1-5
Study summary
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.
Eligibility
Sex
ALL
Min age
14 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards.
2. Age ≥14 years old, ≤ 60 years old, male or female.
3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
4. Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :
1. Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);
2. AST and ALT≤ 2.5 times the upper limit of normal value (same age);
3. Blood creatinine \< 2 times the upper limit of normal (same age);
4. Myocardial enzymes \< 2 times the upper limit of normal (same age);
5. 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 Criteria:
Subjects who meet any of the following criteria are excluded from the study:
1. Acute promyelocytic leukemia with PML-RARA fusion gene
2. Acute myeloid leukemia with BCR-ABL fusion gene
3. Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden).
4. Concurrent malignant tumors of other organs (those requiring treatment).
5. Active heart disease, defined as one or more of the following:
1. A history of uncontrolled or symptomatic angina;
2. Myocardial infarction less than 6 months after enrollment;
3. Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;
4. Uncontrolled or symptomatic congestive heart failure (\> NYHA level 2);
6. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).
7. Those who were not considered suitable for inclusion by the researchers.
Primary outcome measure(s)
Event-free survival (EFS) — up to 2 years after the date of the last enrolled participants All patients definitions for the trial; From the date of enrollment to the time of treatment failure after two courses of induction therapy, recurrence after CRc, date of all-cause death, or the date of last survival follow-up.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.