NCT00943293终止1 期
A Phase I/II Study of Vaccination Against Minor Histocompatibility Antigens HA1 or HA2 After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- To determine in HLA A2 positive patients with hematological malignancies undergoing transplantation from HLA-identical donors, if HA1/2-peptide vaccinations can induce or enhance short- and long-term allogeneic HA1/2-specific T cell immunity.
研究概览
简要总结
This is a clinical research study designed to evaluate whether the administration of a vaccine to patients after transplant consisting of a minor histocompatibility antigen (mHag peptide) mixed with G-CSF (a drug intended to stimulate the immune system) can stimulate increased graft versus leukemia (GVL) responses without causing graft-versus-host disease (GVHD).
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
- •Relapsed or refractory acute myelogenous or lymphoid leukemia.
- •Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.
- •Chronic myelogenous leukemia in accelerated phase or blast-crisis.
- •Chronic myelogenous leukemia in second or subsequent chronic phase
- •Recurrent or refractory malignant lymphoma or Hodgkin's disease
- •Multiple myeloma at high risk for disease recurrence.
- •Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
- •Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features.
排除标准
- •Clinical progression.
- •Contra-indications for vaccination.
研究组 & 干预措施
Vaccine
Experimental
干预措施: Fludarabine (Drug)
Vaccine
Experimental
干预措施: Melphalan (Drug)
Vaccine
Experimental
干预措施: Campath (Drug)
结局指标
主要结局
To determine in HLA A2 positive patients with hematological malignancies undergoing transplantation from HLA-identical donors, if HA1/2-peptide vaccinations can induce or enhance short- and long-term allogeneic HA1/2-specific T cell immunity.
时间窗: 5 years
次要结局
- To evaluate if HA1/2 peptide vaccination induces toxicity, especially acute GVHD after HLA-identical transplantation.(5 years)
研究者
研究点 (1)
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