Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia
Trial statusRecruiting
Trial phasePhase 3
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
the standard "3+7" regimen
DrugIA 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.
Azacytidine; Cytarabine; Aclacinomycin; Chidamide; Venetoclax; Granulocyte
DrugIA 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Venetoclax Combined With CACAG RegimenExperimental treatment 1 intervention
Group B: the standard "3+7" regimenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite Complete Remission (CRc) Rate after 1 course of treatment
a combination of complete remission (CR) and complete remission with incomplete blood count recovery (CRi)
Time frame
1 months after study treatmentSecondary outcomes
1
Overall Response Rate (ORR) after 1 course of treatment
Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).Biological characteristics exploratory studies were analyzed by single-cell sequencing and Atac-seq. Further, according to European LeukemiaNet risk group, we analyzed the outcomes of patients by molecular subtype as a sub-group analysis.
Time frame
1 months after the start of study treatment2
Complete Remission (CR) Rate after 1 courses of treatment
Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts\<5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 10\^9/L (1000/µL); platelet count \>100 x 109/L (100,000/µL); independence of red cell transfusions.
Time frame
after 1 courses of chemotherapy (each course is 28 days)3
Rate of Minimal Residual Disease (MRD)-Negative Response
Percentage of participants who achieved MRD-negative response, defined as \< 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry after each courses of chemotherapy (each course is 28 days)
Time frame
after each courses of chemotherapy (each course is 28 days)4
Event-free survival
Defined as the time interval from treatment initiation to the occurrence of induction failure,relapse,or death,whichever came first.
Time frame
180 days after study treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Fourth Medical Center of PLA General Hospital
Collaborator
The First Medical Center of Chinese PLA General Hospital
Collaborator
The 306 Hospital of People's Liberation Army
Collaborator
Air Force General Hospital of the PLA
Collaborator
Source ClinicalTrials.gov