EUCTR2014-005659-19-GB进行中（未招募）不适用
A phase II study of the use of azacitidine for the treatment of patients with chronic graft-versus-host-disease who have failed therapy with corticosteroids - AZTEC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- 性别
- All
入选标准
- •Patients with moderate or severe cGvHD OR progressive, recurrent or delayed-onset acute GvHD as defined by the NIH Consensus Conference Diagnostic Criteria who have failed therapy with corticosteroids (+/- calcineurin inhibitors).
- •Failure of corticosteroid is defined as either:
- •o progression of cGvHD on 1mg/kg/day prednisolone over 2 weeks
- •o stable cGvHD on =0.5mg/kg/day prednisolone over 4 weeks
- •o inability to taper prednisolone below 0.5mg/kg/day without recurrence of clinical manifestations
- •o inability to tolerate first line therapy* (eg steroid myopathy, calcineurin inhibitor-induced renal toxicity)
- •*Patients must have proven steroid toxicity to meet this criterion for having failed corticosteroid therapy. These cases must be discussed with the Chief Investigator prior to trial entry.
- •Patients must be unable to receive treatment with extracorporeal photophoresis (ECP) therapy (either refractory/intolerant to ECP, lack of ECP availability at local institution or patient/physician preference)
- •Age =16 years of age
- •Life expectancy of at least 3 months with no imminent relapse expected
- •Women of childbearing potential and all men must be using adequate birth control measures throughout the study and for a minimum of 3 months following the end of trial treatment
- •Able to provide written informed consent
- •Patients must be able to comply with all study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •Uncontrolled infection = grade 3 requiring treatment at study entry
- •Neutrophil count <1x109/L (support with GCSF permitted)
- •Platelet count <30 x109/L
- •Known HIV infection
- •Known hepatitis B or C
- •ECOG = 3
- •Patients with ocular GvHD only
- •Pulmonary GvHD
- •Patients receiving active therapy for cGvHD within 14 days of study entry (with the exception of corticosteroids and calcineurin inhibitors)
- •Any investigational agents within 14 days of study entry
- •Treatment with ECP within 6 months of study entry
- •Known hypersensitivity to azacitidine
- •Women who are pregnant or breastfeeding
- •Any other condition that in the Investigator's opinion will affect the patient's participation in this trial
研究者
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