癌研連線CancerLink
已完成 NCT05155709

Siremadlin 聯合 Venetoclax 加 Azacitidine 用於不適合化療的成人急性髓系白血病（AML）患者的研究

白血病Phase IEGFR

一項 Siremadlin 聯合 Venetoclax 加 Azacitidine 用於不適合化療的成人 AML 患者的研究。 本研究的主要目的為評估 Siremadlin 聯合 Venetoclax 加 Azacitidine 能否在不產生不可接受程度的治療期間出現的毒性下，提升不適合化療的 AML 患者的臨床緩解。

適應症：Acute Myeloid Leukemia

收案條件

納入條件

  • Age at the date of signing the informed consent form (ICF):
  • Arm 1 and Arm 2: ≥ 18 years
  • Participants diagnosed with AML based on WHO 2016 classification (Arber et al 2016) who are ineligible for standard induction chemotherapy and:
  • Arm 1 : have received at least 2 cycles and not more than 4 cycles of first-line venetoclax plus azacitidine treatment and have not achieved a CR, CRi, CRh or MLFS.
  • Arm 2 : newly diagnosed AML with adverse genetic risk stratification (according to ELN 2022) (except TP53 mutation positive participants).
  • Participant (in both arms) must be considered ineligible for standard of care intensive induction chemotherapy defined by the following:
  • years of age; OR
  • to 74 years of age with at least one of the following co-morbidities: Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3; Cardiac history of congestive heart failure (CHF) requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina; DLCO ≤ 65% or FEV1 ≤ 65%.
  • Participants must have an ECOG performance status:
  • to 2 for participants ≥ 75 years of age. OR 0 to 3 for participants ≥ 18 to 74 years of age.
  • WBC \< 25x109/L
  • AST and ALT ≤ 3 × ULN
  • Estimated Glomerular Filtration Rate (eGFR)≥ 60 mL/min/1.73 m2

排除條件

  • Prior exposure to MDM2-inhibitor therapy at any time.
  • Participants with TP53 mutation positive.
  • Participants with del17p.
  • Participants with AML-M3 / APL (Acute promyelocytic leukemia) with PML-RARA (Promyelocytic leukemia/retinoic acid receptor alpha) or with AML secondary to Down's syndrome.
  • Participants treated with FLT3 inhibitors for AML indication are not eligible.
  • Participants who require treatment with moderate or strong CYP3A4 inducers within 14 days prior to starting study treatment, or are expected to receive moderate or strong CYP3A4 inducers during the entire study
  • Participants who require treatment with substrates of CYP3A4/5 with a narrow therapeutic index.

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。