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Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia
NCT07514936 · Chinese PLA General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus Daunorubicin and Cytarabine in Fit Older Patients With Acute Myeloid Leukaemia:A Multicenter, Randomized, Controlled, Phase 3 Trial
About this study
This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard "3+7" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.
Eligibility criteria
Inclusion Criteria:
1. Voluntary participation in the clinical study; the subject or legal guardian fully understands and is informed about the study and has signed the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures;
2. Age between 60-75 years at the time of screening, with no gender restrictions;
3. Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition;
4. No severe allergic constitution;
5. Liver function: ALT and AST \<= 2.5 times the upper limit of normal values, bilirubin \<= 2 times the upper limit of normal values;
6. Renal function: creatinine \<= upper limit of normal values;
7. No uncontrollable infections or severe mental illnesses;
8. Performance status score is 0-3 (ECOG), with an expected survival of at least 4 months.
Exclusion Criteria:
1. Patients who are allergic to the study medication or have contraindications to it;
2. Pregnant or breastfeeding women;
3. Patients with active infections;
4. Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results;
5. Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures;
6. Patients who have undergone major organ surgery within the last 6 weeks;
7. Abnormal liver function, with total bilirubin \> 1.5 times the upper limit of normal, ALT/AST \> 2.5 times the upper limit of normal, or liver-infiltrated patients with ALT/AST \> 5 times the upper limit of normal; abnormal renal function, with serum creatinine \> 1.5 times the upper limit of normal;
8. Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-11-18
Estimated completion: 2027-12-31
Last updated: 2026-04-07
Interventions
Drug: the standard "3+7" regimenDrug: Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte
Primary outcomes
- • Composite Complete Remission (CRc) Rate after 1 course of treatment (1 months after study treatment)
Sponsor
Chinese PLA General Hospital · other
With: 940 Hospital of the People's Liberation Army Joint Logistic Support Force, The General Hospital of Western Theater Command, First Affiliated Hospital of Harbin Medical University, 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Contacts & investigators
ContactDahong Liu Liu, doctor · contact · daihongrmg@163.com · +8613681171597
ContactLiping Dou, Doctor · contact · lipingruirui@163.com · +8613681207138
InvestigatorDahong Liu, Doctor · study_chair, Chinese PLA General Hospital
All locations (1)
Chinese PLA General HospitalRecruiting
Beijing, None Selected, China