EUCTR2005-004599-19-AT进行中（未招募）1 期
International collaborative treatment protocol for infants under one year with acute lymphoblastic or biphenotypic leukemia - INTERFANT 06
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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. Children aged 365 days or less with newly diagnosed acute lymphoblastic leukemia (ALL) or biphenotypic leukemia according to EGIL criteria. Children with CNS or testicular leukemia at diagnosis are eligible.
- •2. Morphological verification of the diagnosis, confirmed with cytochemistry and immunophenotyping. In case a bone marrow aspiration results in a dry tap”, a trephine biopsy is advised unless it is possible to confirm the diagnosis by peripheral blood examination.
- •3. Informed consent of the parents or other legally authorized guardian of the patient.
- •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
- •1. Mature B-ALL, defined by the immunophenotypical presence of surface immunoglobulines or t(8;14) and breakpoint as in B-ALL.
- •2. the presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if these data are not known, the patient is eligible).
- •3. Age > 365 days
- •4. Relapsed ALL
- •5. Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.
研究者
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