Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Mye… (NCT07514936) | Clinical Trial Compass
RecruitingPhase 2
Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia
China120 participantsStarted 2024-11-18
Plain-language 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.
Who can participate
Age range60 Years – 75 Years
SexALL
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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
✕
What they're measuring
1
Composite Complete Remission (CRc) Rate after 1 course of treatment
. 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.).