NCT06558253招募中1 期
An Exploratory Study to Assess the Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery After Single-unit Unrelated Cord Blood Transplantation in Patients With Hematological Malignancies
Anhui Provincial Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年11月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adverse Event(AE)
研究概览
简要总结
To assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.
详细描述
A single-center, open-label, dose-escalation study to assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years (inclusive) at screening; gender is not restricted;
- •Diagnosed with hematological malignancies to receive sUCBT for the first time;
- •No severe organ failure and no active infections
- •ECOG performance status of 0-2;
- •Voluntarily participating in the clinical trial, with full understanding of the trial details and having signed the informed consent form.
排除标准
- •Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;
- •Pregnant patients;
- •Patients and/or authorised family members who refuse to receive Coenzyme I for Injection;
- •Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at undue risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive impairment;
- •Participants in other clinical studies affecting hematopoietic recovery within 3 months;
- •Those who are considered by the investigator to be unsuitable for enrolment (e.g., those who anticipate that the patient will not be able to adhere to the examination and treatment due to financial or other issues).
研究组 & 干预措施
Coenzyme I for Injection
Experimental
Subjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection with three dose groups.
干预措施: Coenzyme I for Injection (Drug)
结局指标
主要结局
Adverse Event(AE)
时间窗: From the date of initial treatment to 30 days after transplantation
Number of treatment-related adverse events as assessed by CTCAE v5.0
次要结局
- Probability of overall survival(180 days post transplantation)
- Probability of leukemia-free survival(180 days post transplantation)
- Cumulative incidence of platelet engraftment on day 60(60 days post transplantation)
- Cumulative incidence of primary graft failure on day 30(30 days post transplantation)
- Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100(100 days post transplantation)
- Cumulative incidence of relapse on day 180(180 days post transplantation)
- Cumulative incidence of transplant-related mortality on day 180(180 days post transplantation)
- Probability of GVHD-free relapse-free survival(180 days post transplantation)
- Neutrophil engraftment time(42 days post transplantation)
- Cumulative incidence of neutrophil engraftment on day 16(16 days post transplantation)
- platelet engraftment time(180 days post transplantation)
研究者
研究点 (1)
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