招募中 NCT06764238

新诊断的中/高风险儿童B细胞ALL计划

白血病Phase II

因此,在CCCG-ALL-2015、CCCG-ALL-2020多中心研究队列、同时研究结果和最新临床试验结果的基础上,开发了CCCG-ALL-2025 I/HR-B-ALL ,以进一步改善中高风险B细胞儿童急性淋巴母细胞白血病( I/HR-B-ALL )儿童的无事件生存期( EFS )、总生存期( OS )和生活质量( QOL ) ,同时减少不良反应和移植

适应症:Acute Lymphoblastic Leukemia ALL、Childhood Leukemia, Acute Lymphoblastic、B Cell Acute Lymphoblastic Leukemia (B-ALL)

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 B-ALL by immunophenotyping.

排除标准

  • Low-risk ALL
  • sIgM+
  • 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)

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。