招募中 NCT06855810

新确诊儿童T细胞ALL方案

淋巴瘤白血病Phase II

这是一项在中国儿童癌症协作组(CCCG)内进行的前瞻性、多中心研究。本研究旨在评估加入三种新型药物 dasatinib、venetoclax 及 homoharringtonine 能否提高新确诊T细胞急性淋巴细胞白血病(T-ALL)儿童患者的微量残留病灶(MRD)阴性缓解率、改善无事件生存期(EFS)及降低累积复发发生率(CIR)

适应症:Acute Lymphoblastic Leukemia、Childhood Leukemia, Acute Lymphoblastic、T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma

入组条件

纳入标准

  • Age older than 1 month to younger than 18 years.
  • Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
  • Diagnosis of T-ALL by immunophenotyping.

排除标准

  • B-ALL
  • Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
  • ALL evolved from chronic myeloid leukemia (CML).
  • Down's syndrome, or major congenital or hereditary disease with organ dysfunction
  • Secondary leukemia
  • Known underlying congenital immunodeficiency or metabolic disease
  • Congenital heart disease with cardiac insufficiency.
  • Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)
  • Severe malnutrition, active infections, heart failure, or chemotherapy intolerance.

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。