Efficacy and Safety of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 4, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | December 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
MRD[ Time Frame: up to 32 weeks ] Any change in MRD (flow cytometric) as compared to baseline MRD Immune responses[ Time Frame: up to 32 weeks ] Any change in immunoreactivity (specific and non-specific) as compared to baseline |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Efficacy and Safety of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia | ||
| 正式标题 ICMJE | An International, Multicentre, Open-label Study To Evaluate The Efficacy and Safety of Two Different Vaccination Regimens of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia That Are In Remission With Persistent MRD | ||
| 简要概况 | Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD |
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| 详细说明 | International, multicentre, open-label proof of concept study exploring two different dose groups of the allogeneic dendritic cell vaccine, DCP-001. Cohort 1 consists of 10 patients that will receive 25E6 DCP-001 cells per vaccination and Cohort 2 consists of 10 patients who will receive 50E6 DCP-001 cells per vaccination. All patients will be given two additional booster vaccinations of 10E6 cells. Each patient will be followed up for 12 months after the 4th vaccination. Safety will be monitored throughout the study. Sera and cell samples (blood and bone marrow) will be collected for assessment of efficacy (MRD evaluation) and immune response monitoring. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: Non-Randomized 干预模型: Sequential Assignment 干预模型描述: First 10 patients will get the lowest dose and next 10 patients will receive the highest dose 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
20 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 2021 | ||
| 预计主要完成日期 | December 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Confirmed diagnosis of AML according to WHO2016 criteria, including cytological, molecular and cytogenetic criteria (except acute pro-myelocytic leukaemia/APL). 2. In CR1 (first complete remission) or CRi (incomplete blood count recovery) documented by bone marrow examination up to one month before vaccination; CR defined as less than 5% blasts in normo-cellular bone marrow, ANC >1*E9/L, platelet count >100*E9/L, no evidence of extra-medullary disease. Patients in CRi (patients with <5% blasts but with incomplete blood count recovery) should have platelets >50 E9/L. 3. MRD as defined by multicolour flow cytometry (MFC) at a value of > 0.1%, or detection of specific molecular abnormalities such as NPM1 mutation. 4. Patients that are in CR1 or CRi. Patients not having undergone consolidation therapy must have been in CR1 for at least 1 month prior to enrolment. 5. Expected and willing to undergo all study procedures, including outpatient evaluations for clinical and immunological monitoring. 6. Male or female of ≥ 18 years of age. 7. Women of childbearing potential must be using anti-conceptive therapy or use two (2) barrier contraceptive methods (one by each partner and at least one of the barrier methods must include spermicide (unless spermicide is not approved in the country or region). See section 12.8 for birth control methods deemed acceptable for this study. 8. ECOG (WHO) performance status 0-2. 9. Willing and able to provide written informed consent for participation in the study Exclusion Criteria: 1. Acute Promyelocytic (APL; M3) type of AML. 2. Patients who have undergone or are scheduled for allogeneic stem cell transplantation. 3. History of previous allogeneic bone marrow or solid organ transplantation. 4. Uncontrolled or serious infections 5. Ongoing immunosuppressive therapy, other than short use of low dose steroids, i.e. equivalent to an average dose of ≤10mg of prednisone/day. 6. Chemotherapy and antineoplastic hormonal therapy within 28 days prior to the screening visits. 7. Active autoimmune disease. 8. Inadequate liver function (AST and ALT > 3 x ULN, serum bilirubin >3 x ULN). 9. Other active Malignancies within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin or adequately controlled limited basal cell skin cancer. 10. Pregnant or lactating females. 11. Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment. 12. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease. 13. Evidence of any other medical conditions (such as psychiatric illness, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications. 14. Known HIV, Hepatitis B and/or Hepatitis C infections. 15. History of hypersensitivity to the investigational medicinal product or to any excipient present in the pharmaceutical form of the investigational medicinal product. | ||
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Germany|Netherlands | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | DCPrime BV | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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