A Pilot, Prospective, Randomized, Double-Blinded, Vehicle- and Comparator-Controlled Trial on Safety and Efficacy of a Topical Inhibitor of Janus Kinase 1/2 (Ruxolitinib INCB018424 Phosphate 1.5% Cream) for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease

Memorial Sloan Kettering Cancer Center1 个研究点分布在 1 个国家目标入组 24 人2019年5月14日

适应症Non-sclerotic Cutaneous Chronic Graft-versus-host Disease

干预措施topical ruxolitinib 1.5% cream Topical vehicle/moisturizer cream

相关药物topical ruxolitinib 1.5% cream

概览

阶段: 2 期
干预措施: topical ruxolitinib 1.5% cream
疾病 / 适应症: Non-sclerotic Cutaneous Chronic Graft-versus-host Disease
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 24
试验地点: 1
主要终点: Reduction in Body Surface Area (BSA) From Day 1 and Day 28
状态: 进行中（未招募）
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this study is to compare the safety and effects of ruxolitinib 1.5% cream with those of standard moisturizers in people with non-sclerotic chronic cutaneous GVHD.

注册库

clinicaltrials.gov

开始日期

2019年5月14日

结束日期

2027年2月6日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Memorial Sloan Kettering Cancer Center

责任方

Sponsor

入排标准

入选标准

•Patients (≥ 12 years)
•History of allogeneic hematopoietic stem cell transplantation
•BSA of at least 2% of clinically or histologically confirmed non-sclerotic cutaneous chronic graft-versus-host disease (diagnosed and BSA calculated in accordance with the National Institutes of Health Chronic Graft-versus-Host Disease Consensus for Clinical Trials: I. The 2014 Diagnosis and Staging Working Group Report)
•Patients age ≥ 18 years must provide written informed consent; or patients age ≥12 years and \<18 years must provide assent and have at least one guardian provide written informed consent to participate in the study.
•Able to self-administer topical interventions or provide for another person to apply the topical interventions (while wearing nitrile gloves)
•If on systemic therapy for GVHD, systemic therapy must be stable for past 4 weeks; however, any planned systemic corticosteroid taper during the study will be permitted.Changes in systemic therapy during the study period will be allowed for the management of non-skin GVHD.
•Any concurrent topical therapies including topical corticosteroids, topical calcienurin inhibitors, moisturizers, phototherapy (narrowband UVB or UVA1); or excimer laser therapy must be discontinued on Study Day 0.

排除标准

•Known history of allergy to any ingredient of the study medication
•Patients with deep sclerotic cutaneous graft-versus-host disease including deep sclerotic subtypes of chronic cutaneous GVHD
•Use of concurrent topical therapy including topical corticosteroids, topical calcienurin inhibitors, moisturizers, phototherapy (narrowband UVB or UVA1); or excimer laser therapy after Study Day 0 up to and including Study Day
•Changes in systemic therapy during study period for the purpose of treating skin GVHD.
•Special populations:
•vulnerable populations e.g. decisionally impaired (cognitive, psychiatric), terminally ill, prisoners
•patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent
•Concurrent participation in another topical trial of a drug(s) or medical device, or the subject is in an exclusion period after a previous trial of drug(s) or medical device
•Pregnancy or lactation
•Patients with inadequate liver function (ALT above 4 × upper limit of normal \[ULN\] for the patient's age or direct bilirubin 4 × ULN for the patient's age and the laboratory abnormalities are considered to be due to underlying liver dysfunction) unless attributed to GVHD (if direct bilirubin is not in the medical record, it is acceptable to use total bilirubin x4 ULN).

研究组 & 干预措施

Participants with graft-versus-host disease (GVHD)

Participants will have non-sclerotic chronic cutaneous graft-versus-host disease (GVHD) or you have a condition called superficially sclerotic chronic cutaneous graft-versus-host disease (GVHD) after having received an allogeneic hematopoietic stem cell transplant.

干预措施: topical ruxolitinib 1.5% cream

Participants with graft-versus-host disease (GVHD)

干预措施: Topical vehicle/moisturizer cream

结局指标

主要结局

Reduction in Body Surface Area (BSA) From Day 1 and Day 28

时间窗: 28 days (+/-3 days)

The difference in BSA of non-sclerotic cutaneous cGVHD between ruxolitinib treated side and vehicle treated sides of the face/body at study completion