NCT04971551尚未招募2 期
A Phase 2 ,Safety and Efficacy Study of Jaktinib Hydrochloride Tablets for the Treatment of Steroid-Refractory Acute 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
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) at Day 28
研究概览
简要总结
This is an single-arm, Phase II multi-center study. The purpose of this study is to assess the efficacy and safety of Jaktinib in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease.
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
- •Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible.
- •Clinically suspected Grades II to IV acute GVHD according to NCCN guidelines 2020 V2.0, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program.
- •Subjects with steroid-refractory acute GVHD, defined as any of the following:
- •Subjects with progressive GVHD (ie, increase in stage in any organ system or any new organ involvement) after 3-5 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors（CNI）；Subjects with GVHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 5-7 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors（CNI）；Subjects who Corticosteroid dependence（ie, begin corticosteroids at 2.0 mg/kg per day, demonstrate response, but progress before decrease from the initial starting dose of corticosteroids is achieved）.
- •ECOG: 0-2；
- •Life expectancy > 4 weeks；
- •Ability for oral drug intake；
- •Willingness to comply with all study visits and procedures.
排除标准
- •Has received more than 2 allo-HSCT.
- •Acute GvHD occurring after non-scheduled donor leukocyte infusion (DLI) administered.
- •Has received more than 1 systemic treatment in addition to corticosteroids for acute GVHD.
- •Presence of an active uncontrolled infection.
- •Serum creatinine > 1.5 ULN or creatinine clearance < 30 mL/min calculated by Cockcroft-Gault equation.
- •Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
研究组 & 干预措施
Jaktinib treatment
Experimental
Participants began oral administration of Jaktinib at 75mg twice daily (BID); if stable after the first 3 days of treatment, the dose could be increased to 100mg BID Or continue 75mg BID treatment .
干预措施: Jaktinib Hydrochloride Tablets (Drug)
结局指标
主要结局
Overall Response Rate (ORR) at Day 28
时间窗: Day 28
Defined as the percentage of participants demonstrating a complete response (CR), or partial response (PR).
次要结局
- Overall Survival (OS)(From the first day of Jaktinib treatment to death due to any cause，up to 24 months)
- Incidence and Severity of Adverse Events(From the first day of Jaktinib treatment to 28 days after end of treatment, up to 24 months)
研究者
研究点 (1)
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