Decitabine and Vaccine Therapy for Patients With Relapsed AML Following Allogeneic Stem Cell Transplantation (AML)
2017年5月8日 更新者:University of Louisville
Pharmacologic Upregulation of Cancer Testis Antigens Followed by Vaccine Therapy for Patients With Relapsed Acute Myelogenous Leukemia (AML) Following Allogeneic Stem Cell Transplantation
Patients with Acute Myelogenous Leukemia (AML) who relapse after an allogeneic stem cell transplant cell receive decitabine to up regulate cancer antigen expression, followed by a donor lymphocyte infusion and an autologous dendritic cell (DC).
Vaccine Dendritic cells are pulsed with overlapping peptides derived from MAGE-A1, MAGE-A3, and NY-ESO-1.
研究概览
详细说明
For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.
研究类型
介入性
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。
学习地点
-
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Kentucky
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Louisville、Kentucky、美国、40202
- University of Louisville
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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 75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 for study enrollment:
- Signed informed consent after discussion of alternative therapies.
- The first six patients be18 to 65 years old. Patients # 7-10 will range in age from 2 - 65 years.
Histologically or cytogenetically confirmed diagnosis of acute myelogenous leukemia prior to allogeneic SCT, with the following risk factors:
- > second complete response, or in relapse, at the time of transplant
- monosomy 5 or 7
- the presence of a high FLT3/ITD allelic ratio
- patients with detectable minimal residual disease (MRD) post-transplant
- < 0.5% positive for recipient leukemia cells by flow cytometry
Inclusion criteria to begin study therapy:
- Patient is at least three months post-transplant.
- Patients must be off systemic immunosuppression for at least two weeks prior to the start of therapy on the study.
- ECOG performance status 0-2, Lansky performance status >70 (see Appendix 1).
- Hematologic Function: ANC: ≥ 500; Platelet count: ≥ 75.
Renal Function:
- Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR a serum creatinine based on age/gender using the Schwartz formula:
Cardiac Function: Patient must have normal cardiac function documented within two weeks before starting of a treatment cycle 1 by:
- Ejection fraction (> 55%) documented by echocardiogram or fractional shortening (≥ 28%) documented by echocardiogram.
- Liver Function: Total bilirubin ≤ 1.5 x normal for age, and ALT (SGPT) and AST (SGOT) ≤ 3 x normal for age.
- Room air pulse oximetry > 94%.
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of enrollment.
- Male and female patients must agree to use a medically acceptable barrier and/or chemical contraceptive method during the study and for a minimum of 3 months after the last dose of chemotherapy on this study.
- Subjects must be > 3 months and < 12 months post-SCT at the time of the first vaccination.
- Donor chimerism must be > 90%, assist at least two weeks prior to beginning treatment
- Subjects must be at least 30 days post-transplant to enroll on the study and to undergo apheresis, and must be at least three months post-transplant to begin therapy with DAC/vaccine.
- Stem cell donor source may be related or unrelated donor cord blood, related or unrelated donor bone marrow, and related or unrelated donor peripheral blood stem cell product. Donors may be no more than two HLA (A, B, C, DR, DQ) antigen mismatched with the recipient.
Exclusion Criteria:
- Patient has a history of autoimmune disease, specifically inflammatory bowel disease, systemic lupus erythematosis, or rheumatoid arthritis.
- Patient has a known systemic hypersensitivity to DAC, imiquimod, or any vaccine component.
- Patient has evidence of recurrent leukemia.
- Patient is receiving systemic corticosteroids or other immunosuppression.
- Persistent clinically significant toxicity from prior anticancer therapy that is > Grade 2 (NCI CTCAE v3.0).
- Pregnant or lactating females are excluded.
- Other active systemic malignancy other than leukemia expected to require therapy within 4 months.
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- Any condition which, in the opinion of the investigator, would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
- Patients with a positive result for any of the following diagnostic tests: Hep B Ag, Hep B Core Ab, Hep C Ab, HIV-1 Ab, HIV-2 Ab, HTLV-1 Ab, HTLV-2 Ab, RPR.
- Received any investigational new drug within 30 days prior to the first dose of vaccine , or are scheduled to receive an investigational new during the course of the study
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:非随机化
- 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 |
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实验性的:Safety
Decitabine and donor lymphocyte infused dendritic cell (DC).
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Decitabine followed by donor lymphocyte infusing and Dendritic cells pulsed with MAGE-A1, MAGE-A3, and NEY-ESO-1 vaccine
其他名称:
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有源比较器:Vaccine
Decitabine and Dendritic cell (DC) pulsed with MAGE-A1, MAGE-A3, NY-ESO-1 Peptides
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Decitabine followed by donor lymphocyte infusing and Dendritic cells pulsed with MAGE-A1, MAGE-A3, and NEY-ESO-1 vaccine
其他名称:
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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 |
---|---|---|
Tolerance of study treatment
大体时间:4 years
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Tolerance to DAC, at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles
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4 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Disease Response
大体时间:4 years
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Assessment of Bone Marrow aspiration to check for complete or partial remission, stable disease, and disease progression by bone marrow draws at week 6 and week 12.
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4 years
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Immune Response
大体时间:4 years
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Assessment of post-vaccination T cell responses to MAGE-A1, MAGE-A3, and NY-ESO-1 by immunoassay
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4 years
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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
- 首席研究员:Kenneth G Lucas, MD、University of Louisville
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
2015年3月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2011年11月3日
首先提交符合 QC 标准的
2011年11月30日
首次发布 (估计)
2011年12月1日
研究记录更新
最后更新发布 (实际的)
2017年5月9日
上次提交的符合 QC 标准的更新
2017年5月8日
最后验证
2017年5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.
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