Elderly Patients, Newly Diagnosed Acute Myeloid Leukemia (AML)
Conditions
Keywords
Elderly Patients, newly diagnosed, Acute Myeloid Leukemia
Brief 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.
Interventions
DRUGthe 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.
DRUGAzacytidine; 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.
Sponsors
Chinese PLA General Hospital
940 Hospital of the People's Liberation Army Joint Logistic Support Force
The General Hospital of Western Theater Command
First Affiliated Hospital of Harbin Medical University
960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Fourth Medical Center of PLA General Hospital
The First Medical Center of Chinese PLA General Hospital
The 306 Hospital of People's Liberation Army
Air Force General Hospital of the PLA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized, controlled clinical trial,
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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; 2. Age between 60-75 years at the time of screening, with no gender restrictions; 3. Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition; 4. No severe allergic constitution; 5. Liver function: ALT and AST \<= 2.5 times the upper limit of normal values, bilirubin \<= 2 times the upper limit of normal values; 6. Renal function: creatinine \<= upper limit of normal values; 7. No uncontrollable infections or severe mental illnesses; 8. Performance status score is 0-3 (ECOG), with an expected survival of at least 4 months.
Exclusion criteria
1. Patients who are allergic to the study medication or have contraindications to it; 2. Pregnant or breastfeeding women; 3. Patients with active infections; 4. Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results; 5. Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures; 6. Patients who have undergone major organ surgery within the last 6 weeks; 7. 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; 8. Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Complete Remission (CRc) Rate after 1 course of treatment | 1 months after study treatment | a combination of complete remission (CR) and complete remission with incomplete blood count recovery (CRi) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) after 1 course of treatment | 1 months after the start of study 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. |
| Complete Remission (CR) Rate after 1 courses of treatment | after 1 courses of chemotherapy (each course is 28 days) | 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. |
| Rate of Minimal Residual Disease (MRD)-Negative Response | after each courses of chemotherapy (each course is 28 days) | 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) |
| Event-free survival | 180 days after study treatment | Defined as the time interval from treatment initiation to the occurrence of induction failure,relapse,or death,whichever came first. |
| Overall Survival | 180 days after study treatment | Defined as the time from joining the clinical study to death due to any cause. |
| Treatment-related adverse events | From the first dose of study treatment to 30 days after the discontinuation of treatment | Defined as adverse events that occurred from the first dose of study treatment to 30 days after the discontinuation of treatment. |
| Disease-free survival | 180 days after study treatment Outcome Measure | Defined as the time interval from disease remission to the occurrence of relapse or death,whichever came first. |
| Early death | Within 30 days of the start of the first course of treatment | Defined as death within 30 days of chemotherapy. |
| Complete Remission with Incomplete Blood Count Recovery (CRi)after 1 courses of treatment | after 1 courses of chemotherapy (each course is 28 days | Disappearance of leukemia blasts in the bone marrow (\<5% blasts) but without full recovery of blood counts (neutrophils \<1.0 x 10⁹/L and/or platelets \<100 x 10⁹/L). |
Countries
China
Contacts
CONTACTDahong Liu Liu, doctor
CONTACTLiping Dou, Doctor
STUDY_CHAIRDahong Liu, Doctor
Chinese PLA General Hospital
Outcome results
None listed