EUCTR2019-000718-13-ES进行中（未招募）1 期
A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation. - BOSTON-4
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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.Age = 18 years.
- •2. Patient must have a history of allo-HSCT, regardless of source of stem cell or donor or indication for allo-HSCT
- •3. Documented diagnosis of cGvHD in any organ other than the lung. If BOS is the only manifestation of cGvHD, lung biopsy must have been performed before entering the trial to confirm BOS diagnosis.
- •4.Confirmed diagnosis of BOS Score 1 within > 6 months and < 3 years after allo-HSCT:
- •FEV1/FVC < 0.7 at Screening Visit AND
- •Post-bronchodilator FEV1 = 60 and = 79% predicted at Screening Visit AND
- •=10% decline of FEV1 % predicted within 24 months prior to Screening Visit AND
- •Absence of acute infection in the respiratory tract.
- •5. Patient must be capable of understanding the purposes and risks of the study, has given written informed consent, and agrees to comply with the study requirements.
- •6. Patient is capable of aerosol inhalation.
- •7. Women of childbearing potential must have a negative serum or urine pregnancy test at screening and at randomization visit.
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Active bacterial, viral (as confirmed by multiplex PCR) or fungal infection not successfully resolved at least 4 weeks prior to the Screening Visit.
- •2.Chronic renal dysfunction with serum creatinine = 2.5 mg/dL or need for renal dialysis.
- •3.Chronic hepatic dysfunction with serum total bilirubin > 5x upper limit of normal (ULN), transaminases > 5x ULN, or alkaline phosphatase > 5x ULN.
- •4. Evidence of relapse of the primary malignancy which warranted allogeneic bone marrow transplant.
- •5. Use of azithromycin within 4 weeks prior to Randomization (Visit 1).
- •6. Use of zafirlukast during the study period.
- •7. Chronic oxygen use or use of non-invasive ventilation.
- •8. Active smokers (i.e. any kind of inhaled nicotine consumption).
- •9. Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy over the course of the clinical trial (for details see Appendix II).
- •10. Women who are currently breastfeeding.
- •11. Known hypersensitivity to L-CsA or to cyclosporine A.
- •12. Patients who do not tolerate administration of inhaled bronchodilators (e.g., salbutamol).
- •13. Patients with life-expectancy of less than 6 months.
- •14. Treatments with other Investigational Medicinal Products (IMPs) or previous therapies within four weeks or five times half-life of
- •the drug, whichever is longer prior to screening and during the study. Participation in registries, considering the before, is allowed.
- •15. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion
- •of the necessary procedures.
- •16. Any co-existing medical condition that in the Investigator’s judgment will substantially increase the risk associated with the patient’s participation in the clinical trial.
- •17. Pre-scheduled hospitalizations, surgeries or interventions planned
- •to be performed after obtaining Informed Consent for this study.
研究者
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