Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Toxicity
研究概览
简要总结
Acute myelogenous leukemia (AML) arises from leukemia stem cells that are difficult to eradicate and serve as a reservoir for disease relapse following chemotherapy. A promising area of investigation is the development of immunotherapeutic approaches that stimulate the immune system to recognize leukemia stem cells as foreign and eliminate them. The purpose of this research study is to determine the safety of the Dendritic Cell AML Fusion Vaccine (DC AML vaccine) after participants have achieved a remission with chemotherapy. In this clinical trial, patients are treated with a tumor vaccine alone following standard of care chemotherapy. The DC AML vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. It is hoped that DC AML vaccine will prevent or delay the disease from coming back.
详细描述
- On this study participants will receive the DC AML vaccine and GM-CSF 4-8 weeks after completion of chemotherapy for acute myelogenous leukemia (AML). GM-CSF is a drug that stimulates white blood cells and is given with the DC AML Vaccine in an effort to enhance the effect of the vaccine. Participants will receive 2-3 doses of the vaccine at 4 week intervals.
- All participants will undergo the following procedures: Isolation of tumor cells by either bone marrow biopsy or blood draw; Initial chemotherapy for AML with standard therapy; Leukopheresis (collection of white blood cells from the blood).
- All participants will also have blood tests, a physical exam, and an electrocardiogram prior to each dose of vaccine.
- Four weeks following the final vaccination, participants will undergo a skin test called "delayed-type hypersensitivity" (DTH). This is an injection of the tumor cells under the skin to measure how the immune system responds. The tumor cells are broken up and irradiated to prevent their growth.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AML at initial diagnosis or at first relapse
- •18 years of age or older
- •ECOG Performance Status 0-2
- •Life expectancy of greater than 9 weeks
- •Laboratory values within limits outlined in the protocol
- •Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
- •Prior to Cell Collections for Dendritic Cell Generation:
- •Patients must have obtained complete remission with chemotherapy defined by the absence of circulating blasts, and less then 5% blasts on bone marrow examination following hematopoietic recovery
- •Resolution of all chemotherapy related Grade III-IV toxicity as per CTC criteria 4.0
- •Laboratory values as outlined in the protocol
- •For patients with evidence of minimal residual disease prior to vaccination, assessment of minimal residual disease status by cytogenetics or FISH will be followed post vaccination
- •Prior to Post-Chemotherapy Immunotherapy:
- •Resolution of all chemotherapy related grade III-IV toxicity
- •Laboratory values as outlined in the protocol
- •At least 2 doses of fusion vaccine produced
排除标准
- •Active or history of autoimmune disorders/conditions including Type 1 diabetes. Type II diabetes, vitiligo or stable hyperthyroidism will not be considered exclusion criteria
- •HIV positive
- •Significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia
- •Pregnant women
- •Individuals with a history of a different malignancy are ineligible except for circumstances outlined in the protocol document
- •Prior to Cell Collection for Dendritic Cell Generation:
- •Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
- •Patients who choose to proceed with allogeneic or autologous transplant at the time of remission will not be vaccinated and will come off study
研究组 & 干预措施
Group 1
DC AML Fusion Vaccine
干预措施: DC AML Vaccine (Biological)
结局指标
主要结局
Toxicity
时间窗: 2 years
To assess the toxicity associated with treating AML patients with DC/AML fusion cells in the post-chemotherapy setting
Number of Participants With Adverse Events Associated With DC/AML Tumor Vaccine
时间窗: 6 months after the last vaccine, up to 9 months
Participants were assessed for adverse events associated with treating AML patients with DC/AML fusion cells in the post-chemotherapy setting. Adverse event monitoring occurred monthly through 6 months following the last vaccine (up to 9 months) or until time of disease progression (whichever occurred first.)
次要结局
- Immune Response(2 years)
- T-cell and Immune Response(2 years)
- Disease Response(2 years)
- Immune Expansion After Vaccination(6 months after last vaccine, up to 9 months)
- Number of Patients Who Had Expansion of Leukemia-Specific CD4 and CD8 T-cells After Vaccination(6 months after last vaccine, up to 9 months)
研究者
Jacalyn Rosenblatt
Principal Investigator
Beth Israel Deaconess Medical Center