EUCTR2012-001477-82-Outside-EU/EEA进行中(未招募)不适用
A Children’s Oncology Group pilot study for the treatment of very high risk acute lymphoblastic leukemia in children and adolescents - COGAALL0031
Children's Oncology Group (COG)0 个研究点目标入组 160 人开始时间: 2012年3月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 160
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
- •1. Patients 1 to 20 years of age diagnosed with ALL who achieve remission after frontline induction therapy must have one of the features listed below:
- •a. Ph+ ALL: presence of t(9;22)(q34;q11) determined by institutional cytogenetics or FISH; and/or presence of BCR-ABL fusion transcript identified by RT-PCR
- •b. Hypodiploid with = 44 chromosomes
- •2. Patients 1 to 20 years of age diagnosed with ALL who do not achieve remission after frontline induction therapy must have one of the features listed below:
- •a. M3 (> 25% blasts) bone marrow status at the end of initial induction therapy
- •b. M2 (5-25% blasts) bone marrow status at the end of initial induction therapy and M2 or M3 bone marrow status at end of consolidation therapy (CCG studies) or at the end of the extended induction phase (POG studies).
- •3. Patients who are Ph+, hypodiploid with = 44 chromosomes, or M3 at the end of induction therapy must enroll on study within 42 days of initial diagnosis.
- •4. Patients who are M2 at the end of induction and M2 or M3 at the end of consolidation therapy (CCG) or extended induction therapy (POG) must enroll within 14 days of their last day of frontline therapy
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- 未提供
研究者
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