DRKS00015289招募中3 期
International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
niversitätsklinikum Schleswig-Holstein Campus Kiel0 个研究点目标入组 5,000 人开始时间: 2018年8月28日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 0 Days 至 17 Years（—）
- 性别
- All
入选标准
- •newly diagnosed acute lymphoblastic leukemia or
- •- newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:
- •biphenotypic with a dominant T or B lineage assignment
- •bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
- •- newly diagnosed acute undifferentiated leukemia
- •- age <18 years (up to 17 years and 365 days) at the day of diagnosis
- •- patient enrolled in a participating center
- •- written informed consent to trial participation and transfer and processing of data
排除标准
- •Ph+ (BCR-ABL1 or t(9;22)-positive) ALL2
- •- bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (= 10% of total cells) blast subset
- •- pre-treatment with cytostatic drugs
- •- glucocorticoid pre-treatment with =1 mg/kg/d Prednisolone equivalent for more than two weeks during the last month before diagnosis
- •- treatment started according to another protocol
- •- underlying disease that does not allow treatment according to the protocol
- •- ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
- •- evidence of pregnancy or lactation period
- •- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
- •- participation in another clinical trial except for add-on trials within the scope of supportive care approved by the sponsor
- •- live vaccine immunization within 2 weeks before start of protocol treatment
- •- other condition (either pre-existing or related to leukemia biology as present at diagnosis) or circumstances that significantly conflict with the treatment according to the protocol
研究者
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