这项前瞻性临床试验评估采用第三代TKI olverembatinib、双特异性CD3/CD19 T细胞衔接器 blinatumomab 及BCL-2选择性抑制剂 venetoclax 的「轻化疗」方案,用于新确诊儿童/青少年Ph+ ALL患者的疗效与安全性。与CCCG-ALL-2020方案相比,CCCG-Ph+ B-ALL-2025方案将作以下修改
适应症:Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)、Childhood Leukemia, Acute Lymphoblastic
入组条件
纳入标准
- 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.
排除标准
- 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).
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。