癌研連線CancerLink
已完成 NCT05155709

Siremadlin 联合 Venetoclax 加 Azacitidine 用于不适合化疗的成人急性髓系白血病（AML）患者的研究

白血病Phase IEGFR

一项 Siremadlin 联合 Venetoclax 加 Azacitidine 用于不适合化疗的成人 AML 患者的研究。 本研究的主要目的为评估 Siremadlin 联合 Venetoclax 加 Azacitidine 能否在不产生不可接受程度的治疗期间出现的毒性下，提升不适合化疗的 AML 患者的临床缓解。

适应症：Acute Myeloid Leukemia

入组条件

纳入标准

  • 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

排除标准

  • 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.

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。