NCT04886206招募中1 期
Phase I Study Testing the Injection of Lymphocytes From Haplo-identical Donor Following Chemotherapy in Patients With High-risk Acute Myeloblastic Leukemia Not Eligible for an Allogeneic Hematopoietic Stem Cell Transplantation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- number of DLT
研究概览
简要总结
Patients with high risk AML non eligible for an intensive treatment and for an allogeneic transplantation will be treated with azacitidine and venetoclax. The fourth, fifth and sixth injection of azacitidine will be followed by injection of haplo-identical lymphocytes (HLI). This is a single-center phase I study to identify the dose of HLI with the most tolerable toxicity. TheBayesian continuous reassessment method (CRM) will be used
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •age ≥18 years
- •patients with de novo or secondary AML, with an unfavorable or intermediate karyotype (according to the 2017 ELN classification), or patients with relapsing AML who may receive second-line treatment
- •not candidates for intensive induction, for the following reasons
- •75 years or ≥ 18 to 74 years and at least one of the following comorbidities: PS ≥ 2 or a history of heart failure requiring treatment or LVEF ≤ 50% or chronic stable angina or FEV1 ≤ 65% or DLCO ≤ 65% or creatinine clearance <45 ml / min; or liver damage with total bilirubin> 1.5 N or other comorbidities that the hematologist considers incompatible with intensive treatment
- •ineligible for a classic allogeneic hematopoietic stem cell transplant due to the presence of co-morbidities or too high a risk of toxicity >70 years old or at least one of the following comorbidities: PS ≥ 2 or a history of heart failure requiring treatment or LVEF ≤ 50% or chronic stable angina or FEV1 ≤ 65% or DLCO ≤ 65% or creatinine clearance <45 ml / min; or liver damage with total bilirubin> 1.5 N
- •may receive chemotherapy with hypomethylating agents have a partially compatible (haplo-identical) major family donor (≥18 years old) eligible for lymphocyte donation.
排除标准
- •AML with favorable karyotype (according to ELN 2017) in RC1
- •Patient with refractory or progressive AML
- •Other progressive cancer in progress
- •Karnosky index <60% or PS> 2
- •Severe hepatic function disturbance: transaminases> 5 N, hyperbilirubinemia> 30 µm / L
- •Severe infection requiring hospitalization.
- •Psychiatric illness compromising the understanding of the information or the carrying out of the study.
- •woman of childbearing potential and refusing an effective method of contraception.
- •Adult under tutorship or curatorship, under legal protection or under family authorization
- •Minor family donor (<18 years old)
结局指标
主要结局
number of DLT
时间窗: by day 14
次要结局
- relapse-free survival(1 YEAR)
- cumulative incidence of relapse(1 YEAR)
- overall survival(1 YEAR)
研究者
研究点 (2)
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