2024-517477-24-00招募中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
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The probability of progression-free survival in 24 month FU.
研究概览
简要总结
The main objective of the CLARA STUDY is to assess the tolerance and effectiveness of total body irradiation and cladribine in adult patients diagnosed with AML and myelodysplastic syndromes. The primary research question of this project is to determine the percentage of patients with progression-free survival in 24 month FU
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years (inclusive).
- •Patient is a candidate for allo-HSCT due to AML (intermediate or high risk AML in complete remission, low risk with positive MRD) or high risk myelodysplastic syndrome.
- •Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.
- •Patient signed informed consent form (ICF) prior to any study related screening procedures are performed.
- •Patient has ECOG performance status score of 0 or
- •Patient is a candidate for allo-HSCT from sibling or unrelated donor (full matched or 9/10 mismatched) or from haploidentical donor.
排除标准
- •Has recived more than 1 allo-HCT.
- •Women of childbearing potential who do not agree tmoust use two effective methods of contraception.
- •Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).
- •Known active HIV, HBV or HCV infection (positive PCR test) or risk of HBV reactivation (HBsAg positive).
- •Presence of active disease in AML patients.
- •History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.
- •Presence of severely renal or liver dysfunction (creatinine, ALT, AST or bilirubin concentration > 3.0 ULN (upper limit of normal).
- •Currently pregnancy or breast feeding.
- •Treatment of any other investigational agent in the same time as this study.
- •Known allergies, hypersensivity, or intolerance to cladribine or similar compounds.
结局指标
主要结局
The probability of progression-free survival in 24 month FU.
The probability of progression-free survival in 24 month FU.
次要结局
- Frequency of adverse events in 24 month FU.
- 24-month overall survival probability.
- Disease recurrence probability.
- Mortality unrelated with disease recurrence.
- Likelihood of acute and chronic graft-versus-host disease.
- Time of neutrophil and platelet implantation.
研究者
Clinical Research Support Center
Scientific
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
研究点 (1)
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