NCT07135973尚未招募4 期
A Multi-center, Single-arm Phase IV Clinical Trial to Evaluate the Safety of Belumosudil in Indian Participants, 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Sanofi
- 入组人数
- 26
- 主要终点
- Drug related Grade ≥ 3 treatment emergent adverse events (TEAE)
研究概览
简要总结
This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older.
Study details include:
- The study duration will be up to 12 months per participant.
- The treatment duration will be up to 24 weeks.
- The number of visits will be 7.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients at least 12 years of age inclusive, at the time of signing the informed consent
- •Participants who had an allogeneic hematopoietic cell transplantation (HCT)
- •Previously received at least 2 prior lines of systemic therapy for cGVHD
- •Received glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
- •Had persistent cGVHD manifestations and systemic therapy was indicated
- •Karnofsky (if aged ≥ 16 years)/Lansky (if aged <16 years) Performance Score of ≥ 60
- •Capable of giving signed informed consent as described in the protocol
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Absolute neutrophil count ≤1.5 X 109/L
- •Platelet count ≤ 50 X 109/L
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 X upper limit of normal (ULN) (>5 × ULN if due to cGVHD)
- •Total bilirubin ≥ 1.5 X ULN
- •Glomerular filtration rate (GFR) ≤ 30 mL/min/1.73m3
- •Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening
- •FEV1 ≤39% or has lung score of 3
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
belumosudil
Experimental
200 mg taken orally once daily with food for 24 weeks
干预措施: Belumosudil (Drug)
结局指标
主要结局
Drug related Grade ≥ 3 treatment emergent adverse events (TEAE)
时间窗: From baseline to 24 weeks
Drug related Grade ≥ 3 treatment emergent adverse events (TEAE) during the treatment period (24 weeks)
次要结局
- Best overall Response (BoR)(Baseline to end of study i.e. 12 months)
- Time to Response (TTR)(Baseline to end of study i.e. 12 months)
- Response by organ system (including GSR)(Baseline to end of study i.e. 12 months)
- Change in CNI dose(Baseline to end of study i.e. 12 months)
- Symptomatic improvement from baseline during treatment based on modified Lee Symptom Scale(Baseline to end of study i.e. 12 months)
- Duration of Response (DOR)(Baseline to end of study i.e. 12 months)
- Time taken for New Treatment (TTNT) or death(Baseline to end of study i.e. 12 months)
- Change in Corticosteroid dose.(Baseline to end of study i.e. 12 months)
- Failure-free survival (FFS)(Baseline to end of study i.e. 12 months)
- Pulmonary Function Test (PFT)(Baseline to end of study i.e. 12 months)
- Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs)(Baseline to end of study i.e. 12 months)
- Overall survival (OS)(Baseline to end of study i.e. 12 months)
研究者
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