ACTRN12619000623190招募中2 期
A Phase 2a, open label, multicenter, study to evaluate the pharmacokinetic (PK) profile, safety and efficacy of multiple doses of Cannabidiol (CBD) for the prevention of Acute Graft-Versus-Host Disease (GVHD) after allogeneic hematopoietic cell transplantation (HSCT)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Any malignant hematological disease in CR or Myelodysplastic Syndrome (MDS)
- •2.Age greater than or equal to 18 years
- •3.Karnofsky Score (KS) greater than or equal to 60%
- •4.HSCT-Comorbidity Index (HSCT-CI) score less than or equal to 3
- •5.No major organ dysfunction
- •6.Myeloablative or reduced intensity conditioning regimen
- •7.matched (7/8 or 8/8) unrelated donor
- •8.Peripheral blood stem cell graft
- •9.Subject’s written informed consent
排除标准
- •1.Malignant hematological disease, other than MDS, not in CR
- •2.Myelofibrosis
- •3.Allogeneic transplantation from a matched or mismatched sibling donor
- •4.Cord blood transplantation
- •5.Positive serology for HIV
- •6.Serious psychiatric or psychological disorders
- •7.Any uncontrolled infection at time of registration
- •8. Study subjects must not be pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the trial, as well as within 30 days after the anticipated date the subjects would complete the study.
- •9.Active consumption of illicit drugs (such as: Crack cocaine, Heroin, Methamphetamines, Cocaine, Bath Salts, Amphetamines, Methadone, Benzodiazepine, Marijuana, Ecstasy)
- •10. Use of Cannabis and/or its derivatives fourteen days prior to HSCT and for the duration of study participation
- •11. QTc greater than 450ms per Friderica's correction and impaired cardiac function or clinically significant cardiac disease
- •12. Inadequate renal function defined as measured creatinine clearance greater than 2.0 mg/dl
- •13. Liver enzymes: ALT and AST greater than 3 times the upper limit of normal
- •14. Pregnant or breastfeeding (positive serum beta-HCG 7 days before first dose)
- •15. Treatment with another investigational drug, biological agent, or device within 30 days of first dose, or investigational cell therapy within 6 months of first dose..
研究者
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