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 myelodysplasia

niversity of Birmingham (UK)0 个研究点目标入组 20 人开始时间: 2006年10月5日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Patients satisfying World Health Organisation (WHO) criteria for diagnosis of AML or high risk MDS
•2. Relapsed or refractory AML who are considered unfit for intensive chemotherapy
•3. Patients with de novo AML who are either older than 70 years, or between 60 and 69 years of age with a history of cardiac disease
•4. Patients with high risk MDS judged to be ineligible for intensive chemotherapy or stem cell transplantation
•5. Age equal or greater than 18 years
•6. WHO performance status of zero to two
•7. Patients must be able to swallow capsules
•8. At least two weeks from previous chemotherapy
•9. Patients with White Blood Cell (WBC) count of more than 15 x 10^9/L may receive Hydroxyurea in order to keep the WBC less than 10 x 10^9/L
•10. All men and women must agree to practice effective contraception during the entire study period
•11. All women of child bearing potential must have a negative pregnancy test
•12. Aspartate transaminase less than or equal to 2.5 x the Upper Limit of Normal (ULN)
•13. Total bilirubin less than or equal to 2.5 x the ULN
•14. Calculated creatinine clearance more than or equal to 50 mL/minute
•15. Written informed consent, and the ability of the patient to co-operate with treatment and follow up must be ensured and documented

•1. Patients with contraindications to receiving sodium valproate, ATRA or 5-azacitidine will be excluded from the study. Contraindications are detailed as follows:
•a. sodium valproate - hypersensitivity to sodium valproate, acute liver disease, family history of severe hepatic dysfunction, porphyria, history of pancreatitis, active systemic lupus erythematosis
•b. ATRA - hypersensitivity to ATRA
•c. 5-azacitidine - hypersensitivity to 5-azacitidine
•d. history of sensitivity to theophylline
•2. Patients who are high medical risks because of non-malignant systemic disease, as well as 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 clinical trial
•4. Pregnant or lactacting women
•5. Patients known to be serologically positive for Hepatitis B, C or Human Immunodeficiency Virus (HIV)
•6. Concurrent congestive heart failure or prior history of New York Heart Association class III/IV cardiac disease

发起方

niversity of Birmingham (UK)