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)
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.
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