NCT04239989终止1 期
A Phase I Study to Assess Safety of Selective JAK 1 Inhibitor, Itacitinib, in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplant (HCT)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Monitoring the Dose Limiting Toxicities (DLT) of administering Itacitinib
研究概览
简要总结
This phase I trial studies how well itacitinib works for the treatment of bronchiolitis obliterans syndrome after donor hematopoietic cell transplant. Itacitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVE:
I. To assess the safety of itacitinib in patients with bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic cell transplantation (HCT).
SECONDARY OBJECTIVES:
I. To assess treatment failure at 3 months and 6 months.
II. To assess change in symptom-based lung score at 3 months and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Prior treatment with any other JAK inhibitor (including Ruxolitinib) for BOS or any other indication within the past 6 months of enrolment.
- •Patients on mechanical ventilation or resting by pulse oximetry O2 saturation <88%
- •FEV1 <40% predicted
- •Relapsed primary malignancy for which SCT was performed
- •History of progressive multifocal leuko-encephalopathy (PML)
- •Active uncontrolled bacterial, fungal, parasitic, or viral infection
- •Known human immunodeficiency virus (HIV) infection or active hepatitis B or C infections.
- •History of tuberculosis anytime after SCT
- •Severe renal dysfunction defined by serum creatinine > 2 mg/dL, creatinine clearance <60 mL/minute or dialysis dependence
- •Serum transaminases > 5 × upper limit of normal
- •inability to perform PFT reliably
- •Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- •Lactating/nursing women
- •Life expectancy < 6 months
- •Other severe organ dysfunction unrelated to underlying GVHD. For example, uncontrolled or significant cardiac disease, including any of the following: recent myocardial infarction (within last 6 months from randomization); New York Heart Association Class III or IV congestive heart failure; unstable angina (within last 6 months prior to randomization); clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular; tachycardia, and clinically significant second or third degree AV block without a pacemaker); uncontrolled hypertension. Or any other concurrent severe and/or uncontrolled medical conditions which, in the opinion of the investigator, could compromise participation in the study, pose a significant risk to the subject, or interfere with study results.
研究组 & 干预措施
Treatment (itacitinib)
Experimental
Patents receive itacitinib PO QD for up to 1 year in the absence of disease progression or unacceptable toxicity.
干预措施: Itacitinib (Drug)
Treatment (itacitinib)
Experimental
Patents receive itacitinib PO QD for up to 1 year in the absence of disease progression or unacceptable toxicity.
干预措施: Itacitinib Adipate (Drug)
结局指标
主要结局
Monitoring the Dose Limiting Toxicities (DLT) of administering Itacitinib
时间窗: Up to 6 months
Number of participants who develop DLT's after the administration of the study drug
次要结局
- Treatment failure(At 3 and 6 months)
- Changes in National Institutes of Health (NIH) symptom-based lung score(At 3 and 6 months)
- Change in well-established patient reported outcomes used in chronic graft versus host disease (GVHD) studies(Baseline and at 3 and 6 months)
- Change in 6-minute walk test(Baseline and at 3 and 6 months)
- Failure-free survival(At 6 months)
- Non-relapse mortality(At 6 months)
- Overall survival(At 6 months)
研究者
研究点 (1)
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