NCT05675930招募中2 期
A Multi-Center, Phase II, Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of Photobiomodulation for the Treatment of Oral Chronic Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation (the LIGHT Trial)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 9
- 主要终点
- Response rate of participants
研究概览
简要总结
The purpose of this study is to find out whether photobiomodulation/PBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral Graft-Versus-Host Disease/GVHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double-blind
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allo-HCT recipients
- •Age ≥ 4 years-old
- •Oral cGvHD with NIH-modified OMRS score ≥ 3 who have failed ≥ 1 line of therapy, including topical corticosteroids..
- •No change in systemic immunosuppressive therapy (type or intensity level) within 2 weeks prior to enrollment.
- •If a patient is currently using another oral topical treatment for mouth lesions/symptoms, patient must be stable on this treatment for ≥2 weeks prior to study enrollment. Patient may continue same topical dose/frequency during the study period.
排除标准
- •Presence of an active uncontrolled infection. Subjects with a controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible.
- •Personal history of mucosal head and neck cancer in the past 5 years.
- •Pregnant or breastfeeding.
- •The subject or guardian is unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests.
- •Any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
研究组 & 干预措施
Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)
Active Comparator
Participants are Allo-HCT recipients
干预措施: Photobiomodulation Therapy (Device)
Adult and pediatric patients who received a placebo treatment
Placebo Comparator
Participants are Allo-HCT recipients
干预措施: Placebo sham device (Other)
结局指标
主要结局
Response rate of participants
时间窗: 28 days
To assess the primary objective, we will compare the treatment response rates, defined as the the proportion of oral GvHD allo-HCT patients who achieve a CR or a PR at Day 28, for the PBM and Placebo arms. The treatment response rate will be calculated within each study arm for all patients who completed at least one PBM or placebo treatment.
次要结局
未报告次要终点
研究者
研究点 (9)
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