Clinical trial to evaluate the safety of Bortezomib combined with chemotherapy in children with refractory childhood acute lymphoblastic leukemia - Clinical trial to evaluate the safety of Bortezomib combined with chemotherapy in children with refractory childhood acute lymphoblastic leukemia

Department of Pediatrics, Hokkaido University Hospital0 个研究点目标入组 6 人开始时间: 2013年4月23日最近更新: 2023年10月17日

适应症

试验速览

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•1. patients of Ph1-positive ALL which never receives treatment with tyrosine kinase inhibitor(TKI). 2.patients with Down syndrome. 3.patients with central nerve bleeding and the leukoencephalopathy more than CTCAE ver3.0 Grade3 affecting treatment accomplishment. 4.patients who had the past histories such as epilepsy, Guillain-Barre syndrome, and encephalitis. patients who have intractable epilepsy. 5.patients with uncontrolable infectious disease (including active tuberculosis and HIV infection) 6.patients during the pregnancy or patients who may be pregnant. 7.patients who had the past histories such as congenital or acquired immune deficiency 8. patients whom higher than one of the drugs included in this treatment plan cannot use by past treatment at all. 9.patient who had the past history of more than grade 2 peripheral neuropathy according to CTCAE ver4.0. 10.patients with allergy to mannitol and boron. 11.patients who received anthracyclines more than 350 mg/m2 by doxorubicin conversion in the past. 12.patients who had the past history of treatment-related interstitial pneumonia. Or patients with the abnormal interstitial shadow at the time of start of this study in CT. 13. patients who complicated with a second cancer other than recurrence ALL. 14.In addition, when physicians judge that it is inappropriate that the medical attendant participates in this clinical trial.

发起方

Department of Pediatrics, Hokkaido University Hospital