Interfant-21: International collaborative treatment protocol for infants under one year with KMT2A-rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia

Princess Maxima Center For Pediatric Oncology0 个研究点目标入组 205 人开始时间: 2022年11月29日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•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., = 365 days of age at the time of diagnosis of ALL., Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.

•KMT2A-germline patients., T-ALL., Age > 365 days at the time of diagnosis., Relapsed ALL., Additional exclusion criteria for blinatumomab: 1. CD19 negative B-precursor ALL at diagnosis, Additional exclusion criteria for blinatumomab: 2. CNS involvement (CNS2/CNS3/TLP+ 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)., Additional exclusion criteria for blinatumomab: 3. Proven hypersensitivity to the active substance or any of the excipients in blinatumomab., Additional exclusion criteria for blinatumomab: 4. Patients who have received a live vaccine 28 days prior to blinatumomab administration or plan to receive a live vaccine prior to Bcell recovery after the last dose of blinatumomab.

发起方

Princess Maxima Center For Pediatric Oncology