癌研連線CancerLink
进行中（不再招募） NCT03286634

ASIA 唐氏综合症急性淋巴细胞白血病 2016

白血病Phase II

在亚洲范围研究内，评估以 prednisolone 及低剂量 methotrexate 为基础的方案，用于患有 ALL 的唐氏综合症儿童（DS-ALL）的治疗结果。治疗方案以台湾儿童肿瘤协作组（TPOG）-ALL 方案为骨干作出修改，其中风险分类将改以流式微量残留病灶（MRD）水平作指引。

适应症：Down Syndrome、Acute Lymphoblastic Leukemia、Childhood Cancer

入组条件

纳入标准

  • Down syndrome diagnosed clinically or cytogenetically (including Mosaic Down)
  • Newly diagnosed ALL according to WHO 2016 classification.
  • Age \< 21 years old at time of enrollment.
  • ECOG performance status (PS) score of 0-2.
  • Written informed consent obtained from legally acceptable representatives.

排除标准

  • Second malignancy.
  • Philadelphia positive ALL.
  • Mature B-ALL.
  • Mixed phenotype acute leukemia.
  • Any previous treatment with cytotoxic chemotherapy excluding treatment for TAM or radiation therapy. Patient pre-treated with short term steroid (\< 7 days of duration within last 1 month prior to treatment start) can be enrolled into this study.
  • Renal dysfunction with creatinine \>2x upper limit of normal (ULN). Patients whose creatinine has improved to \<2x ULN before treatment commencement can enrol subject to discretion of site PI.
  • Liver dysfunction with direct bilirubin \> 5x ULN.
  • Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy, including:
  • History of coronary arterial disease, cardiomyopathy, heart failure, arrhythmia (other than sinus arrhythmia) or severe cardiac malformation which with residual abnormalities or requires further major corrective surgery within 2 years.
  • Ongoing uncontrolled hypertension.
  • Ongoing uncontrolled diabetes mellitus.
  • Ongoing uncontrolled infection.
  • History of congenital or acquired immunodeficiency including HIV infection.
  • History of interstitial pneumonia, pulmonary fibrosis, bronchiectasis or severe pulmonary emphysema.
  • CNS hemorrhage.
  • Psychiatric disorder.
  • Other concurrent active neoplasms.
  • Pregnant or lactating women.
  • Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator.

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。