這是一項開放標籤、第二期研究，評估口服三氧化二砷（Arsenol ®）聯合抗壞血酸及研究者選擇的低強度治療，用於既往未接受治療或復發／難治性TP53突變型急性髓系白血病（AML）、骨髓增生異常綜合症（MDS）、慢性粒單核細胞白血病（CMML）患者。
適應症：Acute Myeloid Leukemia、Myelodysplastic Neoplasm、Chronic Myelomonocytic Leukemia、TP53 Gene Mutation、Arsenic Trioxide
收案條件
納入條件
- 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.
排除條件
- 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
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。