这是一项开放标签、第二期研究，评估口服三氧化二砷（Arsenol ®）联合抗坏血酸及研究者选择的低强度治疗，用于既往未接受治疗或复发／难治性TP53突变型急性髓系白血病（AML）、骨髓增生异常综合症（MDS）、慢性粒单核细胞白血病（CMML）患者。
适应症：Acute Myeloid Leukemia、Myelodysplastic Neoplasm、Chronic Myelomonocytic Leukemia、TP53 Gene Mutation、Arsenic Trioxide
入组条件
纳入标准
- Willing and able to provide informed consent
- Age ≥18 years
- Diagnosis of acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS) or chronic myelonocytic leukaemia (CMML) by World Health Organization (WHO) 2022 criteria (1, 3)
- Presence of TP53 mutation
- Previously untreated patients for Cohort A (Treatment-naïve), or Patients failing 1 or more lines of prior treatment for Cohort B (Relapsed and Refractory)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Women of childbearing potential and fertile men must agree to use an approved method of contraception from Screening until 30 days after the last dose of oral arsenic trioxide, ascorbic acid, venetoclax and azacitidine/decitabine/oral-decitabine-cedazuridine.
- Willing and able to provide informed consent
- Age ≥18 years
- Diagnosis of acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS) or chronic myelonocytic leukaemia (CMML) by World Health Organization (WHO) 2022 criteria (1, 3)
- Presence of TP53 mutation
- Previously untreated patients for Cohort A (Treatment-naïve), or Patients failing 1 or more lines of prior treatment for Cohort B (Relapsed and Refractory)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Women of childbearing potential and fertile men must agree to use an approved method of contraception from Screening until 30 days after the last dose of oral arsenic trioxide, ascorbic acid, venetoclax and azacitidine/decitabine/oral-decitabine-cedazuridine.
排除标准
- Use of an investigational agent within 14 days of study treatment (or at least 7 half-lives of that agent, whichever is longer), prior to the first dose of oral arsenic trioxide
- Known hypersensitivity to arsenic trioxide, ascorbic acid, venetoclax or azacitidine/decitabine/oral-decitabine-cedazuridine or their excipients.
- Uncontrolled, active infection
- Major surgery within 4 weeks of starting the study drug, or not recovered from side effects of surgery
- Any other serious medical conditions that could compromise study participation, in the opinion of the investigator
- Known HIV infection or known, active hepatitis B or hepatitis C infection
- Concurrent second active and non-stable malignancy (patients with a concurrent second active but stable malignancy, i.e., non-melanoma skin cancers, are eligible)
- Known history of long QT syndrome (LQTS) or corrected QT interval by Fridericia formula (QTcF) ≥ 480 ms
- Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to hemolysis) as defined by any of the following local laboratory parameters:
- Calculated glomerular filtration rate (GFR; using the Cockcroft-Gault equation or eGFR; using CKD-EPI) \< 40 mL/min
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x the local upper limit of normal
- Pregnant or lactating females, or females planning to become pregnant at any time during the study
- Unwilling or unable to comply with the study protocol
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。