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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 75
Healthy Volunteers: f
View:
• 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;
• Age between 60-75 years at the time of screening, with no gender restrictions;
• Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition;
• No severe allergic constitution;
• Liver function: ALT and AST \<= 2.5 times the upper limit of normal values, bilirubin \<= 2 times the upper limit of normal values;
• Renal function: creatinine \<= upper limit of normal values;
• No uncontrollable infections or severe mental illnesses;
• Performance status score is 0-3 (ECOG), with an expected survival of at least 4 months.
Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Dahong Liu Liu, doctor
daihongrmg@163.com
+8613681171597
Backup
Liping Dou, Doctor
lipingruirui@163.com
+8613681207138
Time Frame
Start Date:2024-11-18
Estimated Completion Date:2027-12-31
Participants
Target number of participants:120
Treatments
Experimental: Venetoclax Combined With CACAG Regimen
The entire treatment period for the CACAG+Venetoclax regimen in the trial is 2 week, with a treatment cycle of every 4 weeks, and a total of 2 course of treatment.~Chidamide: 30 mg, twice a week, for a total of 4 administrations; Azacitidine: 75 mg/m\^2 from day 1 to day 7; Cytarabine (Ara-C): 75-100 mg/m\^2 every 12 hours from day 1 to day 7; Aclarubicin: 20 mg/m\^2 on days 1, 3, and 5; Recombinant human granulocyte colony-stimulating factor (G-CSF): 300 μg/day, to be discontinued when neutrophils recover and white blood cell count is ≥20,000/μL; Venetoclax: 100 mg on day 1, 200 mg on day 2, 400 mg from day 3 to day 14, used in combination with azoles, with a reduced dosage of 100 mg/day.
Active_comparator: the standard 3+7 regimen
IA Regimen:~Idarubicin: 8-12 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7.~Or DA Regimen:~Daunorubicin: 60 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7.~Or MA Regimen:~Mitoxantrone: 6-10 mg/m\^2 on days 1 to 3; Cytarabine (Ara-C): 100 mg/m\^2 every 12 hours on days 1 to 7.
Collaborators: 940 Hospital of the People's Liberation Army Joint Logistic Support Force, 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China, First Affiliated Hospital of Harbin Medical University, The General Hospital of Western Theater Command