NCT06046248招募中2 期
Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of patients who achieve partial and complete responses after treatment
研究概览
简要总结
This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD)
- •Previously untreated, defined by having received <10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD
- •KPS >/= 70%
- •Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC >750 cells/mm3; Platelets >30,000 cells/mm#
排除标准
- •Late persistent or recurrent aGVHD
- •Active uncontrolled infection
- •History of HIV infection
- •Active HBV or HCV infection. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded.
- •Calculated CrCl <30mL/min
- •AST and/or ALT >5x ULN or direct bilirubin >3x ULN
- •Cardiac ejection fraction <40% or history of uncontrolled cardiac arrhythmias
- •Has received more than one allogeneic transplant prior to the occurrence of cGVHD
研究组 & 干预措施
Belumosudil Plus Rituximab
Experimental
Belumosudil plus Rituximab
干预措施: Belumosudil (Drug)
Belumosudil Plus Rituximab
Experimental
Belumosudil plus Rituximab
干预措施: Rituximab (Drug)
结局指标
主要结局
Number of patients who achieve partial and complete responses after treatment
时间窗: 2 years
次要结局
- Length of time patients remain on corticosteroid treatment(2 years)
- Number of patients who had treatment-related adverse events using CTCAE v5(2 years)
研究者
研究点 (2)
Loading locations...
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