Donor Immune Cell Therapy for Acute Myeloid Leukemia
2022年4月17日 更新者：First Affiliated Hospital Xi'an Jiaotong University
Trial of Donor Immune Cell Therapy for Acute Myeloid Leukemia.
This study aims to introduce a new technology of donor NK cell infusion.
NK cells defend against viruses and cancer cells in vivo whereas this effect declines in patiens with tumors.
In this study, NK cells will be separated from donated peripheral blood or umbilical cord blood.
Eligible NK cells will be infused to patients with Acute myeloid leukemia (AML).
This new therapy will probably induce their sustained remission and reduce recurrences.
研究概览
详细说明
Primary end point:
To determine the rate of overall survival at 2 years of Interventional cohort
Secondary end point:
To determine the cumulative incidence of relapse at 2 years. To determine the rate of disease-free survival at 2 years. Describe the safety and toxicity of donor NK cell infusion.
Study Design:
This study is a phase I clinical trial. 15 eligible AML patients will be enrolled sequentially to receive detached NK cells product during induction or consolidation therapy. Refractory or relapsed patients and patients who achieved complete remission (CR) after induction therapy are included. They will receive anthracycline-based chemotherapy according to NCCN guidelines. At the same time, Cultured NK cells will be infused into patients after chemotherapy. Anti-allergic therapy and prophylaxis of graft versus host disease (GVHD) will be given before infusion. Treatment effect will be measured and adverse effect will be treated and documented after intervention.
研究类型
介入性
注册 (预期的)
15
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：huaiyu Wang, doctor
- 电话号码：0086-18991232410
- 邮箱：whymed@126.com
研究联系人备份
- 姓名：sha Gong, doctor
- 电话号码：0086-18710720955
- 邮箱：314621649@qq.com
学习地点
-
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Shaanxi
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Xi'an、Shaanxi、中国、710016
- 招聘中
- First Affiliated Hospital of Xian Jiaotong University
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接触：
- Huaiyu Wang, Doctor
- 电话号码：0086-15809207527
- 邮箱：whymed@126.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients must have been diagnosed as acute myeloid leukemia in accordance with "Chinese Diagnosis and Treatment Guidelines of AML". Those who achieved CR after chemotherapy are mainly included. Refractory/relapsed AML can also be enrolled.
- Patients with normal heart function (ejection fraction ≥ 50%), normal liver function(ALT and AST ≤ 2.5 times the upper limit of normal value, bilirubin ≤ 2 times the upper limit of normal value) and normal renal function with blood creatinine ≤ 3.0 mg/dL (≤ 260 µmol /L) can be enrolled.
- Patients will be required to sign an informed consent.
Exclusion Criteria:
- Patients with severe infection or other malignant tumors.
- Women during pregnancy or lactation.
- Other patients deemed unsuitable by the investigator.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：immune cell arm
Umbilical cord blood or donated peripheral blood of healthy donors were collected and NK cells were cultured.
NK cell production will be infused after chemotherapy.
|
Umbilical cord blood or donated peripheral blood of healthy donors were collected and NK cells were sorted and cultured.
NK cell production will be infused after chemotherapy
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
hematological response rate
大体时间：up to 2 years, from treatment begining to death
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Hematological Complete Remission (HCR): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x10^9/L; platelet count >100x10^9/L.
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up to 2 years, from treatment begining to death
|
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Overall survival
大体时间：Up to 2 years after beginning treatment
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Overall survival (OS) is measured from the date of first infusion of NK cells to the date of death from any cause; patients not known to have died at last follow up are censored on the date they were last known to be alive.
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Up to 2 years after beginning treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative incidence of relapse
大体时间：Up to 2 years after beginning treatment
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Relapse was defined as the recurrence of above 5%bone marrow blasts and the reappearance of blasts in the blood or the development of extramedullary disease infiltrates at any site.
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Up to 2 years after beginning treatment
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Disease free survival (DFS)
大体时间：Up to 2 years after beginning treatment
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Disease free survival (DFS) is defined as the time from the date of first infusion of NK cells to the date of relapse or death as a result of any cause.
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Up to 2 years after beginning treatment
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Incidence of adverse effects
大体时间：Up to 2 years after beginning treatment
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Toxic effects were graded according to the National Cancer Institute's Common Toxicity Criteria.
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Up to 2 years after beginning treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：huaiyu Wang, doctor、First Affiliated Hospital Xi'an Jiaotong University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ruggeri L, Capanni M, Casucci M, Volpi I, Tosti A, Perruccio K, Urbani E, Negrin RS, Martelli MF, Velardi A. Role of natural killer cell alloreactivity in HLA-mismatched hematopoietic stem cell transplantation. Blood. 1999 Jul 1;94(1):333-9.
- Miller JS, Soignier Y, Panoskaltsis-Mortari A, McNearney SA, Yun GH, Fautsch SK, McKenna D, Le C, Defor TE, Burns LJ, Orchard PJ, Blazar BR, Wagner JE, Slungaard A, Weisdorf DJ, Okazaki IJ, McGlave PB. Successful adoptive transfer and in vivo expansion of human haploidentical NK cells in patients with cancer. Blood. 2005 Apr 15;105(8):3051-7. doi: 10.1182/blood-2004-07-2974. Epub 2005 Jan 4.
- Bachanova V, Cooley S, Defor TE, Verneris MR, Zhang B, McKenna DH, Curtsinger J, Panoskaltsis-Mortari A, Lewis D, Hippen K, McGlave P, Weisdorf DJ, Blazar BR, Miller JS. Clearance of acute myeloid leukemia by haploidentical natural killer cells is improved using IL-2 diphtheria toxin fusion protein. Blood. 2014 Jun 19;123(25):3855-63. doi: 10.1182/blood-2013-10-532531. Epub 2014 Apr 9.
- Curti A, Ruggeri L, Parisi S, Bontadini A, Dan E, Motta MR, Rizzi S, Trabanelli S, Ocadlikova D, Lecciso M, Giudice V, Fruet F, Urbani E, Papayannidis C, Martinelli G, Bandini G, Bonifazi F, Lewis RE, Cavo M, Velardi A, Lemoli RM. Larger Size of Donor Alloreactive NK Cell Repertoire Correlates with Better Response to NK Cell Immunotherapy in Elderly Acute Myeloid Leukemia Patients. Clin Cancer Res. 2016 Apr 15;22(8):1914-21. doi: 10.1158/1078-0432.CCR-15-1604. Epub 2016 Jan 19.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年7月1日
初级完成 (预期的)
2024年7月1日
研究完成 (预期的)
2024年9月1日
研究注册日期
首次提交
2022年3月23日
首先提交符合 QC 标准的
2022年4月17日
首次发布 (实际的)
2022年4月19日
研究记录更新
最后更新发布 (实际的)
2022年4月19日
上次提交的符合 QC 标准的更新
2022年4月17日
最后验证
2021年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.