JPRN-jRCTs051230126招募中3 期
International collaborative treatment protocol for infants under one year with KMT2A-rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia - Interfant-21
Miyamura Takako0 个研究点目标入组 16 人开始时间: 2023年11月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 12month old（—）
- 性别
- All
入选标准
- •1. Patients with newly diagnosed B- precursor ALL or B-cell MPAL according to the WHO classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017), with KMT2A-rearrangement.
- •2. -<365 days of age at the time of diagnosis of ALL.
- •3. Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.
排除标准
- •1. KMT2A-germline patients.
- •2. T-ALL.
- •3. Age > 365 days at the time of diagnosis.
- •4. Relapsed ALL.
- •5. Treatment with systemic corticosteroids (equivalent prednisone >10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.
- •Additional exclusion criteria for blinatumomab:
- •1. CD19 negative B-precursor ALL at diagnosis
- •2. CNS involvement (CNS2/CNS3 status) at the EOI. Patients with CNS disease at the time of diagnosis are eligible if CNS1 status is achieved prior to the start of the first blinatumomab cycle (lumbar puncture at ~day 33 of induction).
- •3. Proven hypersensitivity to the active substance or any of the excipients in blinatumomab.
- •4. Patients who have received a live vaccine 28 days prior to blinatumomab administration or plan to receive a live vaccine prior to B-cell recovery after the last dose of blinatumomab.
- •If exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.
研究者
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