Acute myeloid leukemia
Conditions
Interventions
Experimental group:lisatoclax (a BCL-2 inhibitor) combined with daunorubicin and cytarabine (modified "6+3" regimen)
Sponsors
Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 to 65 years, regardless of sex. 2.Newly diagnosed AML? according to the 2022 WHO Classification? (excluding the APL subtype [AML-M3]) and treatment-naïve? (no prior chemotherapy). 3.Deemed suitable for intensive chemotherapy; Eastern Cooperative Oncology Group (ECOG)? performance status 30 mL/min? calculated via the Cockcroft-Gault formula. 5. Liver function is good, as shown by: (1) Serum total bilirubin 25 × 10^9/L). 8.Female patients must be non-childbearing? or using highly effective contraception.Male subjects must agree to refrain from unprotected sexual intercourse and sperm donation from the first dose until 90 days after the last dose. 9.Written informed consent must be obtained prior to any study procedures. If signing the consent form is deemed detrimental to the patient's psychological well-being or clinical condition, it may be signed by a legal guardian? or immediate family member? on behalf of the patient.
Exclusion criteria
Exclusion criteria: 1.Acute Promyelocytic Leukemia (APL). 2.AML with BCR::ABL1; or Blast Phase of Chronic Myeloid Leukemia (CML-BP). 3.Prior exposure to chemotherapy, hypomethylating agents (HMAs), or venetoclax? for the treatment of AML. 4.History of Myelodysplastic Syndromes (MDS), Myeloproliferative Neoplasms (MPN), or MDS/MPN overlap syndromes. 5.Concurrent malignancy during the treatment period, except for:Basal cell carcinoma or squamous cell carcinoma of the skin;Cervical carcinoma in situ;Breast carcinoma in situ;Incidentally discovered prostate cancer (e.g., localized, low-grade) confirmed by histopathology. 6.Pregnant or breastfeeding women. 7. Active heart disease is defined by any of the following: (1) Uncontrolled or symptomatic angina; (2) Myocardial infarction within the past 6 months; (3) Arrhythmias that require medication or cause serious symptoms; (4) Uncontrolled or symptomatic congestive heart failure (NYHA > Class 2); (5) Left ventricular ejection fraction below the lower limit of the normal range; 8.Subjects with active, uncontrolled systemic fungal, bacterial, or viral infections that have not improved despite appropriate antibiotic, antiviral, and/or antifungal therapy. 9.Active HIV, Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection that is uncontrolled by therapy. 10.Evidence of Central Nervous System (CNS) leukemia? prior to treatment. 11.History of epilepsy, dementia, or other psychiatric conditions requiring pharmacological intervention that would impair the subject's ability to understand or comply with the protocol. 12.Conditions that may limit oral drug intake or gastrointestinal absorption (e.g., malabsorption syndrome, major bowel resection). 13.Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite Complete Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of relief;Severity of adverse events;Hematopoietic recovery time;Minimal residual disease Rate;Overall Survival;Event-Free Survival;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactZhangsong Yan
Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed