NCT04861207进行中（未招募）2 期
Assessment of Tolerance and Effectiveness of Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Maria Sklodowska-Curie National Research Institute of Oncology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年10月7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
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The probability of progression-free survival in 24 month follow up
研究概览
简要总结
A single center, prospective, one arm clinical study to assess the tolerance and effectiveness of total body irradiation and cladribine in adult patients diagnosed with AML( acute myeloid leukemia) and myelodysplastic syndromes.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years.
- •Patient is a candidate for allogeneic hematopoietic cell transplantation due to acute myeloid leukemia(intermediate or high risk acute myeloid leukemia in complete remission, low risk with positive Minimal residual disease) or high risk myelodysplastic syndrome.
- •Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.
- •Patient signed informed consent form prior to any study related screening procedures are performed.
- •Patient has Eastern Cooperative Oncology Group performance status score of 0 or
- •Patient is a candidate for allogeneic hematopoietic cell transplantation from sibling or unrelated donor (full matched or 9/10 mismatched) or from haploidentical donor.
排除标准
- •Has received more than 1 allogeneic hematopoietic cell transplantation.
- •Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).
- •Known active human immunodeficiency virus, hepatitis B virus or hepatitis C virus infection (positive polymerase chain reaction test) or risk of hepatitis B virus reactivation (Hepatitis B surface antigen positive).
- •Presence of active disease in acute myeloid leukemia patients.
- •History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.
- •Presence of severe renal or liver dysfunction (creatinine, alanine aminotransferase,aspartate aminotransferase or bilirubin concentration > 3.0 upper limit of normal
- •Currently pregnancy or breast feeding.
- •Treatment of any other investigational agent in the same time as this study.
- •Known allergies, hypersensitivity, or intolerance to cladribine or similar compounds.
- •Women of childbearing potential who do not agree to use two effective methods of contraception.
研究组 & 干预措施
Cladribine
Experimental
干预措施: Cladribine (Drug)
结局指标
主要结局
The probability of progression-free survival in 24 month follow up
时间窗: 24 month follow up
次要结局
- 24-month overall survival probability(24 month follow up)
- Likelihood of acute and chronic graft-versus-host disease(24 month follow up)
- Time of neutrophil and platelet implantation(24 month follow up)
- Mortality unrelated with disease recurrence(24 month follow up)
- Frequency of adverse events(24 month follow up)
- Disease recurrence probability.(24 month follow up)
研究者
研究点 (1)
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