Dose-escalation Study of D-CMG Regimen for the Treatment of Elderly Newly Diagnosed AML Patients

Más betegség

• History of myeloproliferative neoplasms (MPN), including myelofibrosis, primary thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and AML with BCR-ABL1 translocation.
• HIV-positive patients and/or active HBV or HCV infection (as documented by positive HBV-DNA and HCV-RNA tests).
• Active, uncontrolled severe infection.
• History of other malignancies within the past 2 years, except for adequately treated in situ carcinoma of the cervix or breast; skin basal cell carcinoma or localized squamous cell carcinoma of the skin.
• Mental impairment that would compromise the ability to participate in the study.

Laborértékek

• Clinically significant QTc prolongation (men > 450 ms; women > 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block, history of myocardial infarction within the past year, congestive heart failure, and coronary artery disease requiring medication.
• White blood cell count > 25 x 10\^9/L. (This criterion can be met with hydroxyurea or leukapheresis.)

Egyéb

• Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16).
• Active central nervous system leukemia.
• Any other situation in which the investigator believes that it would not be in the best interest of the patient to participate in the trial.

• Histologically confirmed acute myeloid leukemia (non-M3) that has not been previously treated and cannot receive standard cytarabine and anthracycline induction therapy due to age, comorbidities, or patient preference.
• Aged 60-75 years, both male and female, with an expected survival time of more than 3 months.
• Estimated creatinine clearance rate ≥ 30 mL/min.
• AST and ALT ≤ 3.0 x ULN (unless considered due to leukemic organ involvement). Bilirubin ≤ 1.5 x ULN (unless considered due to leukemic organ involvement).
• ECOG Performance Status ≤ 2.
• Able to understand and voluntarily provide informed consent.