The phase II clinical trial of the novel induction therapy by low-dose cytarabine and blinatumomab for relapse/refractory ALL and investigational biological studies - JPLSG-ALL-R19-BLI

Goto Hiroaki0 个研究点目标入组 45 人开始时间: 2021年11月24日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Subjects who meet all inclusion criteria can be enrolled to the study.
•1) Patients who were diagnosed to have B cell precursor-ALL (including Pre-B ALL) when they were at 18-year-old or younger age.
•2) either of disease status of;
•1. 1st or later bone marrow relapse including relapse after SCT (in patients with 1st relapse ALL, only when phsicians consider that intensive cytotoxic chemotherapy is inappropriate because of physical conditions or other reasons.)
•2. refractory ALL (patients with primary or relapsed ALL who cannot achieve CR after intensive chemotherapy)
•3) Patients with informed consent or with guardian's informed consent
•4) Patients who have registered into the study of Classification of newly diagnosed Hematological Malignancy - 2014 (CHM-14) of Japanese Pediatric Leukemia/Lymphoma Study Group and have the JPLSG number

•Subjects who have either f these criteria cannot enroll to the study.
•1)CD19-negative ALL (20% or lower blasts are positive for CD19 by FCM)
•2)CNS or testis disease at the study enrollment
•3)Isolated extramedullary relapse
•4)Patients who have other cancer
•5)Refractory disease after blinatumomab
•6)Chemotherapy except for glucocorticoid as a single agent or intratechal chemotherapy within 2 weeks
•7)Radiation therapy within 2 weeks
•8)Drug allergy for cytarabine or blinatumomab
•9)Uncontrolled convulsion
•10)Past or present autoimmune disease involving CNS disease
•11)Grade 2 or higher grade acute GVHD or chronic GVHD requiring systemic therapy
•12)Laboratory data abnormalities (either of)
•1.AST and/or ALT; 5 or more times higher than normal upper limit
•2.Total bilirubin; 1.5 or more times higher than normal upper limit
•3.eGFR; lower than 30 ml/min/1.73m2
•13)HIV, HBV, or HCV infection
•14)Pregnant or lactating woman

发起方

Goto Hiroaki