🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06635681
Recruiting Phase 2

Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML

NCT06635681 · tracked via the Priya Life Science China tracker
Sponsor
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 \&gt;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\&#39;s condition, if the patient\&#39;s signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient\&#39;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)

Trial sites (1)

FacilityCityRegionStatus
Blood Diseases Hospital Tianjin Tianjin Municipality Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

More Institute of Hematology & Blood Diseases Hospital, China trials in China

Other trials for the same condition

Official registry record

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.

View NCT06635681 on ClinicalTrials.gov ↗ ← All trials in China