ISRCTN80896844已完成不适用
Vaccination with human minor H antigen (HA-1) peptide in patients showing minimal residual disease or mixed chimerism after allogeneic stem cell transplantation and donor lymphocyte infusion
eiden University Medical Centre (LUMC) (Netherlands)0 个研究点目标入组 24 人开始时间: 2008年11月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with acute myeloid leukaemia (AML), myelodysplasia (MDS), acute lymphoblastic leukaemia (ALL), chronic myeloid leukaemia (CML) in accelerated phase or blastic transformation before transplantation, chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or aggressive lymphoma, who underwent allo-SCT (both myeloablative and non-myeloablative) followed by DLI for persistent mixed chimerism or smoldering disease
- •2. Patient and donor HLA-A2 positive, patient HA-1 positive, donor HA-1 negative
- •3. World Health Organization (WHO) performance status of 0, 1 or 2
- •4. Female patients of childbearing potential must be neither pregnant nor breastfeeding and must agree to use effective contraception (birth control pills, condoms, approved implant, or intra-uterine device [IUD]) during the course of this trial and for at least three months after the last injection
- •5. Mixed chimerism or persisting disease 8 weeks after DLI
- •6. Male and female, aged 18 years and older
排除标准
- •1. Life expectation of less than 3 months
- •2. Psychological disturbances
- •3. Severely limited life expectation due to diseases other than the malignancy
- •4. Human immunodeficiency virus (HIV) positivity
- •5. Persistent treatment with high-dose corticosteroids (greater than 20 mg prednisone a day), chemotherapy or other immunosuppressive drugs
- •6. Rapidly progressive disease
- •7. GVHD grade 3 or 4
- •8. HA-1 specific immune response (defined by greater than 0.2% of total CD8+ cells in first six patients and defined by greater than 1.0% of total CD8+ cells in patients 4 - 24 if no toxicity greater than grade II in first three patients). No important increase in percentage HA-1 specific CD8+ cells between 6 and 8 weeks after DLI (defined as a doubling of this percentage resulting in a percentage of greater than 0.2%).
研究者
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