招募中 NCT06882057

新确诊低风险儿童B细胞ALL方案

白血病Phase II

CCCG-ALL2025 LR-B-ALL计划是基于CCCG-ALL2020计划设计。这是一项临床试验,在所有新确诊暂定低风险(LR)儿童急性淋巴细胞白血病(ALL)患者中,于诱导治疗后使用14天 blinatumomab(Blina-14)作为早期强化治疗,并于巩固治疗中使用第二次Blina-14,不论可测量残留病灶(MRD)状态如何。

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

  • Must meet all items below:
  • Age older than 1 year and younger than 18 years.
  • Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
  • Diagnosis of B-ALL by immunophenotyping.
  • Low risk group

排除标准

  • Should be excluded in the presence of any item below:
  • T-ALL
  • I/HR B-ALL group
  • sIgM+
  • Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
  • Philadelphia chromosome positive ALL (Ph-ALL)
  • 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.
  • Glucocorticoid treatment 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。