Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

ovartis Pharma K.K0 个研究点目标入组 20 人开始时间: 2017年8月15日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•Histologically confirmed diagnosis of Ph+ or bcr-abl + ALL. Refractory to or ineligible for initial remission induction therapy remission induction therapy
•Patients with histologically confirmed diagnosis of ALL.
•Patients confirmed to be Ph chromosome positive or bcr-abl gene positive.
•Patients in relapse
•Patients refractory to initial remission induction therapy
•Patients ineligible for initial remission induction therapy
•Patients with an ECOG Performance Status Score from 0 to 2
•Serum creatinine concentration of not more than 2 × the upper limit of the normal range (ULN)
•AST (SGOT) and ALT (SGPT) of not more than 3 × ULN. In patients with hepatic dysfunction from leukemic involvement, AST (SGOT) and ALT (SGPT) should be not more than 5 × ULN
•Serum bilirubin level not more than 3 × ULN
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug
•Patients with findings indicative of leukemic involvement of the central nervous system
•Patients with any serious concomitant medical condition (e.g., poorly controllable infection, interstitial pneumonia, pulmonary fibrosis, congestive cardiac failure, poorly controlled diabetes mellitus, mental disorder)
•Patients expected to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug
•Patients having received any hematopoietic stem cell transplantation who have a Grade 3 or 4 GVHD.

发起方

ovartis Pharma K.K