Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia

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

Overview

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.

Interventions

• Drug 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.
• Drug Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte
  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.

Primary outcome measures

• Composite Complete Remission (CRc) Rate after 1 course of treatment [Time frame: 1 months after study treatment]

Secondary outcome measures (9)

• Overall Response Rate (ORR) after 1 course of treatment [Time frame: 1 months after the start of study treatment]
• Complete Remission (CR) Rate after 1 courses of treatment [Time frame: after 1 courses of chemotherapy (each course is 28 days)]
• Rate of Minimal Residual Disease (MRD)-Negative Response [Time frame: after each courses of chemotherapy (each course is 28 days)]
• Event-free survival [Time frame: 180 days after study treatment]
• Overall Survival [Time frame: 180 days after study treatment]
• Treatment-related adverse events [Time frame: From the first dose of study treatment to 30 days after the discontinuation of treatment]
• Disease-free survival [Time frame: 180 days after study treatment Outcome Measure]
• Early death [Time frame: Within 30 days of the start of the first course of treatment]
• Complete Remission with Incomplete Blood Count Recovery (CRi)after 1 courses of treatment [Time frame: after 1 courses of chemotherapy (each course is 28 days]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Patients who are allergic to the study medication or have contraindications to it;
• Pregnant or breastfeeding women;
• Patients with active infections;
• Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results;
• Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures;
• Patients who have undergone major organ surgery within the last 6 weeks;
• 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;
• Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT07514936 · KY-2024-9-140-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗