PHASE II STUDY OF CLOFARABINE IN COMBINATION WITH CYTARABINE AND LIPOSOMAL DOXORUBICIN IN CHILDREN WITH EITHER LYMPHOBLASTIC OR MYELOID RELAPSE OR REFRACTORY ACUTE LEUKEMIA AND IN CHILDREN WITH SECONDARY ACUTE MYELOID LEUKEMIA - CLA-MYOCET

AZIENDA SANITARIA OSPEDALIERA O.I.R.M. - S. ANNA0 个研究点开始时间: 2012年3月8日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•- Age at diagnosis between 1 and 21 years (20 years and 364 days) - Second or subsequent isolated bone marrow relapses of ALL - Refractory ALL - First or subsequent isolated bone marrow relapses of AML - Either refractory or secondary AML in patients who received previous chemotherapy - Lansky or Karnofsky Performance Status score > 60% - Life expectancy > 6 weeks - Normal Heart function (VEF = 55% 2-D echocardiography) and history negative for concomitant medication to treat cardiopathy -Good organ function defined by: 1) serum creatinine <2 times the upper limit for age, 2) total bilirubin <1.5 times the upper limit of age, 3) transaminases = 2.5 times the upper limit for age, 4) alkaline phosphatase = 2.5 times the upper limit for age -For female patients with childbearing potential, a negative test for pregnancy is to be considered before entry on study -Male and female patients must use an effective contraceptive method during the study and for a minimum of 3 months after study treatment; -Written signed informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Isolated extramedullary relapse of ALL and AML -First isolated bone marrow relapse of ALL -Patients with involvement of central nervous system (CNS) at diagnosis of refractory / relapse of ALL and AML or of secondary AML -Early (<3 months) bone marrow relapse after HSCT (hematopoietic Stem Cell Transplantation) -acute promyelocytic leukemia -Acute leukemia in first or subsequent isolated bone marrow relapse or refractory in patients with Down Syndrome - Current or recent (<30 days) history of either fungal or bacterial infections requiring treatment at diagnosis of either relapsed/refractory ALL/AML or secondary AML -Chemotherapy treatment in the 2 weeks before study entry. Granulocyte growth factor, leukapheresis and cranial irradiation should be discontinued at least 48 hours before the beginning of the protocol - Severe organ dysfunction, especially liver, kidneys, heart and lungs -Other concurrent severe disease that makes it inappropriate to enroll the patient in the study - History of a previous veno-occlusive disease (VOD) -Expected non-compliance to protocol schedule or unable to have regular follow-up due to psychological, social, familial reasons -Hypersensitivity to cytarabine, clofarabine, liposomal daunorubicin -Concomitant administration of any other experimental drug under investigation, or concurrent treatment with any other anti-cancer therapy other than specified in the protocol is not allowed -Pregnant or lactating patients

发起方

AZIENDA SANITARIA OSPEDALIERA O.I.R.M. - S. ANNA