Newly Diagnosed Acute Myeloid Leukemia (TN AML) That Can Tolerate Intensive Therapy (fit)
Conditions
Interventions
Experimental group:Sonrotoclax combined with chemotherapy
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed untreated acute myeloid leukemia; 2. Age 18 to 75 years old; 3. Eastern Cooperative Oncology Group (ECOG) score = 30 mL/min) Cardiac function (left ventricular ejection fraction >=50%); 5. If the age >=60 years old, the following conditions must be met; Charlson comorbidity index (CCI)100 No cognitive impairment, Mini-Mental State Examination (MMSE)>=28 No impairment of ability to live, Short Form Physical Status Scale (short). physical performance battery protocol, SPPB)>=9; 6. Women of childbearing potential must have a negative serum pregnancy test =180 days after the last dose of study drug. 7. Non-sterile males must use a highly effective method of birth control during study treatment and for 90 days = after the last dose of study drug. During this time, they are not allowed to donate sperm. 8. Patients fully understand this study, obtain the informed consent form (ICF) signed by the patient or his legal representative, and follow the study protocol and follow-up process. 9. Life expectancy greater than 12 weeks.
Exclusion criteria
Exclusion criteria: 1.Acute promyelocytic leukemia (APL); 2.Malignant tumor in the past 2 years, except for cured localized skin cancer, superficial bladder cancer, cervical cancer or cancer in situ of breast cancer, and localized prostate cancer with Gleason score = 6; 3.Uncontrolled concurrent diseases, including but not limited to: ongoing or active uncontrolled infections, cardiovascular or mental illnesses/social situations that may limit compliance with research requirements; 4.It is known that the subjects are positive for hepatitis B or hepatitis C infection, except those whose viral load cannot be detected within 3 months (Note: patients with HBcAb+but HBsAg - can only meet the condition if hepatitis B virus (HBV) DNA cannot be detected in the detection with sensitivity = 20 IU/mL. In this case, patients should receive regular monitoring of HBV DNA and receive prophylactic antiviral drug treatment according to the central diagnosis and treatment routine; Patients with HCV antibody+are eligible only if they cannot detect HCV RNA and are willing to monitor HCV reactivation; 5.Receive any moderate or strong CYP3A4 inhibitor (7 days or 5 half-lives, whichever is longer) or moderate or strong CYP3A4 inducer (14 days or 5 half-lives, whichever is longer) treatment before the first use of Sonrotoclax; 6.Patients who are known to have hypersensitivity reactions to any component in the study protocol; 7.Known central nervous system involvement in AML; 8.Previously received organ, bone marrow, or peripheral blood organ transplantation; 9.Participate in another therapeutic clinical study simultaneously; 10.Pregnant or lactating women, or male and female patients planning to have children during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year event free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite complete remission rate;The complete remission rate of MRD negative at the end of induction therapy, consolidation therapy,;Relapse-free survival;2-year overall survival (OS) rate;Mortality within 30 days after first study and mortality within 60 days after first study; | — |
Countries
China
Contacts
Public ContactJunmin li
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed