A phase 2, multi-centre study to evaluate the efficacy and safety of Dexamethasone, ifosfamide, carboplatin, and etoposide in treating patients with refractory lymphoblastic lymphoma - JPLSG ALB-R13

Mitsui Tetsuo0 个研究点目标入组 24 人开始时间: 2019年3月29日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Satisfy all the following conditions.
•1) Precursor B/T-cell lymphoblastic lymphoma (LBL) which was diagnosed through histological or cellular pathological analysis. Specimens submission is mandatory for central pathological review.
•2) Recurrent or refractory (LBL) without central nervous infiltration. Criterion of recurrent or refractory is described in 3.6.2. of the protocol.
•3) Primary disease onset was more than one year old and less than 18yo. Refractory or recurrent diagnosis was made less than 20yo.
•4) Sufficient organs functions are mandatory, as bellows. The inspections for the criterion should be done within 14days from study registration.
•Total bilirubin <= 3.0mg/dl
•Serum creatinine <= 0.8 mg/dl (under 4yo)
•<= 1.2 mg/dl (5 to 9yo)
•<= 1.5 mg/dl (from 10yo)
•There is no need of medication for arrhythmia. Electrocardiogram shows no QT prolongation. The cardiothoracic ratio is beneath 55% in chest X-ray. No heart failure sign under physiological studies.
•If heart failure is suspected, an echo-cardiogram should be done. Ejection fraction >=50% and fractioning shortening >=25% is competent for the study.
•If above all abnormal criterion are due to the LBL and the protocol therapy are probably made improvement of functions, the patient is competent for the study.

•1) Down syndrome.
•2) Central nervous infiltration.
•3) The presence of Philadelphia chromosome under chromosomal or chimeric gene analysis.
•4) Myelodysplastic syndrome.
•5) The past history of other cancer.
•6) The past history of organ transplantation including allogeneic blood stem cell transplantation.
•7) The past history of congenital and acquired immunodeficiency.
•8) When the doctor in charge think that the patient should be excluded for a suitable reason.

发起方

Mitsui Tetsuo