ISRCTN15649711已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/34446853 Results of first stage (tolerability) of two-stage study (added 18/12/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 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:
- •1.1. Progression of cGvHD on 1 mg/kg/day prednisolone over 2 weeks
- •1.2. Stable cGvHD on =0.5 mg/kg/day prednisolone over 4 weeks
- •1.3. Inability to taper prednisolone below 0.5mg/kg/day without recurrence of clinical manifestations
- •1.4. Inability to tolerate first line therapy* (eg steroid myopathy, calcineurin inhibitorinduced 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.
- •2. 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)
- •3. Age =16 years of age
- •4. Life expectancy of at least 3 months with no imminent relapse expected
- •5. 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
- •6. Able to provide written informed consent
- •7. Patients must be able to comply with all study procedures
排除标准
- •1. Uncontrolled infection = grade 3 requiring treatment at study entry
- •2. Neutrophil count <1x109/L (support with GCSF permitted)
- •3. Platelet count <30 x109/L
- •4. Known HIV infection
- •5. Known hepatitis B or C
- •6. ECOG = 3
- •7. Patients with ocular GvHD only
- •8. Pulmonary GvHD
- •9. Patients receiving active therapy for cGvHD within 14 days of study entry (with the exception of corticosteroids and calcineurin inhibitors)
- •10. Any investigational agents within 14 days of study entry
- •11. Treatment with ECP within 6 months of study entry
- •12. Known hypersensitivity to azacitidine
- •13. Women who are pregnant or breastfeeding
- •14. 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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