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临床试验/EUCTR2011-003430-13-IE
EUCTR2011-003430-13-IE进行中(未招募)1 期

Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)

Children's Oncology Group0 个研究点目标入组 9,483 人开始时间: 2013年10月10日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
9,483

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients must be enrolled on the classification study AALL08B1 prior to treatment and enrollment on AALL0932 (except for B-LLy patients who are not eligible for AALL08B1).
  • B-ALL patients must be >365 days and <10 years of age. B-LLy patients must be >365 days and =<30.99 years of age.
  • B-ALL patients must have an initial white blood cell count <50000/µL.
  • Patients must have newly diagnosed NCI Standard Risk B-ALL or B-LLy Murphy Stage I or II. Patients with Down syndrome are also eligible.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed previously, with the exception of steroid pretreatment and intrathecal cytarabine.
  • Patients with CNS3 positive disease.
  • B-ALL patients with testicular leukemia.
  • B-LLy patients with
  • - T-lymphoblastic lymphoma
  • - Morphologically unclassifiable lymphoma
  • - Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
  • - M2 (5%-25% blasts) or M3 (>25% blasts) marrow.

研究者

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