Phase II Study of the Tolerability and Efficacy of the Histone Deacetylase Inhibitor Sodium Valproate given in Conjunction with 5-azacytidine and ATRA (all trans retinoic acid ) in Patients with Acute Myeloid Leukaemia. - Val/Aza

niversity of Birmingham0 个研究点目标入组 80 人开始时间: 2006年1月31日最近更新: 2019年6月30日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: niversity of Birmingham
入组人数: 80

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

入选标准

•1) Satisfy WHO criteria for diagnosis of AML or high risk MDS
•2) Relapsed/refractory AML/high risk MDS
•3) de novo AML aged over 70
•4) High risk MDS/AML in whom intensive chemotherapy is not clinically indicated
•5) Age equal or greater than 18 years
•6) WHO performance status 0,1,2
•7) Able to swallow capsules
•8) At least 2 weeks from previous chemotherapy
•9) Men and women to practive effective contraception
•10) Women of child bearing potential must have a negative pregnancy test
•11) Aspartate transaminase/alanine aminotransaminases, total bilirubin, alk phosphatase less than or equal to 2.5 times the upper limit of normal
•12) Calculated creatinine clearance greater than or equal to 50 ml/min
•13) Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1) Patients with contraindications to receiving sodium valproate, ATRA or 5-azacitidine will be excluded
•2) Patients who are high medical risks because of non-malignant systemic disease and those with active uncontrolled infection
•3) Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the trial
•4) Pregnant or lactating women
•5) Patients known to be serologically positive for Hepatitis B, C or HIV
•6) Concurrent congestive heart failure or prior history of New York Heart Association Class III/IV cardiac disease

研究者

发起方

niversity of Birmingham

相似试验

已完成

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Phase II study of the tolerability and efficacy of the histone deacetylase inhibitor sodium valproate administered in conjunction with 5-azacitidine, theophylline and all trans-retinoic acid in patients with acute myeloid leukaemia and high risk myelodysplasiaAcute myeloid leukaemia or high risk myelodysplasiaLeukamiaCancer

ISRCTN68418952niversity of Birmingham (UK)20

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