The Efficacy and Safety of VA Alternating With Low-dose CHA in the Treatment of Newly Diagnosed Unfit AML: a Prospective, Multi-centers, Single Arm Phase II Study
This phase II trial tests how well VA alternating with low-dose CHA works in treating unfit patients with newly diagnosed acute myeloid leukemia (AML). This is a prospective, multi-centers, single arm phase II study aimed to overcome VEN resistance and achieve greater MRD negative rate, providing better control of treatment for unfit AML.
• Understand the research and sign a written informed consent form;
• Be newly diagnosed with AML according to WHO 2022 criteria without prior treatment;
• or unwilling to undergo IC. Ineligibility for IC is defined as meeting any of the following criteria:
• Age ≥ 60 years
• Age 18-59 years but ineligible for intensive chemotherapy (IC) , meet ≥1 of the following:
‣ Eastern Cooperative Oncology Group (ECOG) performance status ≥2 at screening;
⁃ Severe heart failure (congestive heart failure requiring treatment or myocardial infarction history with ejection fraction ≤50%);
⁃ Severe pulmonary dysfunction (DLCO ≤65%, FEV1 ≤65%, dyspnea at rest, or oxygen dependence);
⁃ Severe renal insufficiency requiring dialysis;
⁃ Child-Pugh B or C cirrhosis, or hepatic impairment with total bilirubin \>1.5×ULN;
• Mental illness requiring inpatient psychiatric treatment;
• Any comorbidity deemed by physician to contraindicate IC.