Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Korábbi kezelés

• 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;
• 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；
• Previously received organ, bone marrow, or peripheral blood organ transplantation；

Más betegség

• 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;
• 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；
• Patients who are known to have hypersensitivity reactions to any component in the study protocol;

Egyéb

• Acute promyelocytic leukemia (APL)；
• Known central nervous system involvement in AML;
• Participate in another therapeutic clinical study simultaneously；
• Pregnant or lactating women, or male and female patients planning to have children during the study period.

• Newly diagnosed untreated acute myeloid leukemia patients;
• Age range from 18 to 75 years old;
• The Eastern Cooperative oncology Group (ECOG) score is ≤ 2 points;
• The following organ functional conditions must be met:
  • Liver function (bilirubin<2mg/dL, AST and/or ALT<3 x ULN)
  • Renal function (blood creatinine clearance rate ≥ 30 mL/min)
  • Cardiac function (left ventricular ejection fraction ≥ 50%)
• If the age is ≥ 60 years old, the following conditions must be further met;
  • Charlson comorbidity index (CCI) ≤ 1
  • Activity of Daily Living Scale (ADL)>100
  • No cognitive impairment, Mini Mental State Examination (MMSE) ≥ 28
  • No impairment of living ability, Short Physical Performance Battery Protocol (SPPB) ≥ 9
• Women with fertility must have a negative serum pregnancy test ≤ 7 days before the first administration. In addition, they must use efficient contraceptive methods before the first dose of study medication, during the study treatment period, and for ≥ 180 days after the last dose of study medication.
• Non infertile males must use efficient contraceptive methods during the study treatment period and within ≥ 90 days after the last dose of the study medication. During this period, they are not allowed to donate sperm.
• The patient fully understands this study, obtains an informed consent form (ICF) signed by the patient or their legal representative, and follows the research protocol and follow-up process.
• The expected lifespan is greater than 12 weeks.