NCT01146262Unknown1 期
Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
Dendritic cells vaccinations are increasingly used in order to develop antitumoral immune response. This will be a Phase 2 trial using autologous dendritic cells pulsed with leukemic apoptotic corpse in acute myelogenous leukemia (AML) patients in first or second Complete remission (CR).
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Informed consent signed
- •Serology HIV, hepatitis B, hepatitis C, HTLV 1 and 2 and Syphilis always negative (new achievement tests)
- •Performance Statute <=2
- •Must not be eligible for allogeneic transplantation
- •No progressive disease
- •Bone marrow and/or peripheral blasts >50% before chemotherapyBlasts >=2.4 10*8 (collected prior to chemotherapy) available No contraindication to cytapheresis
- •AML in CR2, except M3-AML
- •Patients with refractory AML after induction treatment and a patient eligible for salvage treatment may allow the production of a first complete remission.
- •Patient with newly diagnosed AML with unfavorable cytogenetics and for whom (which) a course of intensive induction and consolidation treatment for outpatients are possible
- •Patient with newly diagnosed AML with a non-adverse cytogenetics AND either refused to participate in the protocol GOELAMS LAMS-2007, against the
排除标准
- •, indicating participation in the protocol GOELAMS LAMS-2007 and for whom (which) a course of induction and intensive out patient treatment for consolidation are possible
- •Absence of donor HLA-compatible family or non-family and absence of placental blood available for performing an allograft.
- •Exclusion Criteria
- •Patients who, for reasons psychological, social or geographical boundaries, could be monitored during the study
- •No infections or visceral (cardiac, lung, brain, ...) serious uncontrolled
- •History of positive allogeneic bone marrow or solid organ transplantation.
- •Previous history of autoimmune disease other than vitiligo
- •History of other cancer, except cervical carcinoma in situ or basal cell carcinoma of the skin unless deemed cured for over 5 years.
- •Inability to collect at the diagnosis of relapsed AML, enough leukemic cells (> 2.4 x108)
- •Inability to collect during remission, a sufficient number of monocytes in two leukapheresis maximum
- •Failure to obtain a maturation of monocytes
- •Patient with AML 3
- •Patient may receive an allogeneic hematopoietic stem cell
- •No treatment related to treatment of molecules in preclinical development underway or completed MA within the last 4 weeks
结局指标
主要结局
Adverse events
时间窗: 6 weeks
Primary objective: assess the tolerability of autologous apoptotic corps pulsed dendritic cells vaccine in acute myelogenous leukemia patients in first or second Complete remission. (CR2)
次要结局
- immune response(Day 14)
- Complete remission(18 months)
- Survival(18 months after injection)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Dendritic Cell Vaccination in Patients With Advanced Colorectal CancerColorectal NeoplasmsNCT00311272University Hospital, Gentofte, Copenhagen40
已完成
1 期
Dendritic Cell-based Immunotherapy in MesotheliomaMalignant Pleural MesotheliomaNCT00280982Erasmus Medical Center10
已完成
2 期
Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumor Lysate or Homogenate Combined With Immunomodulating Radiotherapy and/or Preleukapheresis IFN-alfa in Patients With Metastatic Melanoma: a Randomized "Proof-of-principle" Phase II StudyMalignant Melanoma of Skin Stage IIIMalignant Melanoma of Skin Stage IVNCT01973322Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS34
已完成
2 期
Dendritic Cells in Lung CancerNon Small Cell Lung CancerNCT00442754Herlev Hospital50
已完成
不适用
Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple MyelomaMultiple Myeloma and Plasma Cell NeoplasmLymphomaNCT00937183Jan Walewski12