The multicenter study for purposes of detection of prognostic factor of advanced stage pediatric lymphoblastic lymphoma treated with standard chemotherapy - ALB-NHL-14

Mori Takeshi0 个研究点目标入组 90 人开始时间: 2019年3月29日最近更新: 2023年10月17日

试验速览

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•(1) diagnosis of precursor T-cell lymphoblastic lymphoma or precursor B-cell lymphoblastic lymphoma (ratio of blast in bone marrow is less than 25%)
•(2) diagnosis of stage III/IV disease
•(3) age under 20 year old at diagnosis
•(4) registration at JPLSG CHM-14 study
•(5) no history of previous anti-cancer therapy except listed below ;
•a) biopsy or surgical resection
•b) emergency irradiation therapy within 7days
•c) prednisolone therapy within 7 days
•d) VCR or DNR therapy within 7 days in order to improve severe dyspnea
•(6) ECOG performance status (PS) score of 0-2, or worsening to 4 due to lymphoma
•(7) sufficient hepatic and renal function satisfying the laboratory data listed below ;
•a) T-Bili: within 3x of age adjusted upper-limit of normal range.
•b) Creatinine: within 3x of age adjusted upper-limit of normal range.
•(8) observation for at least 3 years after biginning treatment
•(9) written informed consent obtained from patient or guardians.

•(1) Down syndrome.
•(2) Other previous illness of malignant tumor or previous therapy of organ transplantation including hematopoietc stem cells.
•(3) history of congenital or acquired immunodeficiency.
•(4) uncontrolled infection, including active tuberculosis infection and positive of HIV antibody.
•(5) pregnancy or high possibility of pregnancy and giving suck woman.
•(6) QTfc, corrected by Friderics formula as QTfc = QT/RR*1/3, is more than 0.45 seconds.
•(7) CNS hemorrage more than grade 3 of CACAE v4.0
•(8) MDS, Ph1 positive
•(9) any inappropriate status judged by

发起方

Mori Takeshi