招募中 NCT07152041

新確診兒童Ph陽性B-ALL方案

白血病Phase IIICD19

這項前瞻性臨床試驗評估採用第三代TKI olverembatinib、雙特異性CD3/CD19 T細胞銜接器 blinatumomab 及BCL-2選擇性抑制劑 venetoclax 的「輕化療」方案,用於新確診兒童/青少年Ph+ ALL患者的療效與安全性。與CCCG-ALL-2020方案相比,CCCG-Ph+ B-ALL-2025方案將作以下修改

適應症:Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)、Childhood Leukemia, Acute Lymphoblastic

收案條件

納入條件

  • Must meet all items below:
  • Age older than 1 month to younger 18 years.
  • Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.
  • Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.

排除條件

  • Should be excluded if had any item below:
  • ALL evolved from CML.
  • Known underlying congenital immunodeficiency or metabolic disease.
  • Congenital heart disease with cardiac insufficiency.
  • Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug.
  • Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases.
  • Subjects with significant CNS disorder (e.g., uncontrolled seizure disorder, autoimmune disease involving CNS).
  • Treated with glucocorticoids for ≥14 days, or targeted inhibitor for \> 7 days within one month before enrollment, or any chemotherapy or any systemic anticancer therapy (including but not limited to any TKI) or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression).

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。