Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60-75
SponsorChinese PLA General Hospital
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- the standard "3+7" regimen
- Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chinese PLA General Hospital
Lead sponsor
940 Hospital of the People's Liberation Army Joint Logistic Support Force
Collaborator
The General Hospital of Western Theater Command
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Collaborator
Source ClinicalTrials.gov