NCT05975996招募中2 期
Cyclophosphamide Added to Standard Immunosuppressive Therapy With Herombopag as Front-line Therapy in Patients With Severe Aplastic Anemia
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年7月10日最近更新:
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
- 43
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
This is a prospective, single-center, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of Anti-lymphocyte globulin plus herombopag in combination with moderate-dose cyclophosphamide for severe aplastic anemia.
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 age ≥ 12 years
- •Subject has a diagnosis of naïve severe or very severe aplastic anemia
- •ECOG performance status ≤2
- •Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation.
- •Willing and able to comply with the requirements for this study and written informed consent.
排除标准
- •Previously received immunosuppressive therapy > 4 weeks
- •Previously treated with TPO-RA > 4 weeks
- •Have an allergy or intolerance to either herombopag or cyclophosphamide.
- •Have an allergy to ALG
- •Uncontrolled systemic fungal, bacterial, or viral infection
- •Poorly controlled hypertension (≥140/90mmHg) or diabetes (a fasting plasma glucose concentration ≥7.0mmol/L or a random venous plasma glucose concentration ≥11.1mmol/L)
- •Abnormal liver or kidney function: ALT or AST >3 ULN, or serum creatinine (sCr)≥ 2.5 ULN.
- •History of radiotherapy and chemotherapy for malignant solid tumors
- •Combined with other serious disorders
- •Pregnant or breast-feeding patients
- •Patients considered to be ineligible for the study by the investigator for reasons other than the above.
研究组 & 干预措施
Experiemental
Experimental
ALG/CsA(Cyclosporine) and herombopag and moderate-dose cyclophosphamide
干预措施: Cyclophosphamide added to standard immunosuppressive therapy with herombopag (Drug)
结局指标
主要结局
Overall response rate
时间窗: Within 3 months
Percentage of patients with hematological response. Hematological response includes complete rate, near complete rate(CR), very good partial response(VGPR), good partial response(GPR) and partial response(PR).
次要结局
- Robust response(Within 3 months)
- All-cause mortality(Within 3 months)
- Incidence of the adverse event(Within 6 months)
- Time to achieve robust hematological response(Within 6 months)
研究者
研究点 (1)
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