NL-OMON37222已完成不适用
Vaccination with HA-1 peptide in patients showing minimal residual disease or mixed chimerism after allogeneic stem cell transplantation and donor lymphocyte infusion. - HA-1 peptide vaccination after stem cell transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria for DLI-group:
- •- Patients with AML, myelodysplasia (MDS), ALL, CML in accelerated phase or blastic transformation, CLL, MM or aggressive lymphoma, who underwent allo SCT (both myeloablative and non-myeloablative) followed by DLI for persistent mixed chimerism or smoldering disease, or patients who underwent an allo SCT for the same diseases who are not eligible for standard DLI but have persistent mixed chimerism or smoldering disease.
- •- Patient and donor HLA-A2 positive, patient HA-1 positive, donor HA-1 negative.
- •- WHO performance status of 0, 1 or 2
- •- 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 IUD) during the course of this trial and for at least three months after the last injection.
- •- Informed consent given by patient;Inclusion criteria for non-DLI group:
- •- Patients with AML, myelodysplasia (MDS), ALL, CML in accelerated phase or blastic transformation before transplantation, CLL, MM or aggressive lymphoma, who underwent allo SCT (both myeloablative and non-myeloablative)
- •- At least three months after allo SCT presence of persisting disease or mixed chimerism as indication for Donor Lymphocyte Infusion.
- •- Contra indication for the infusion of unselected Donor Lymphocyte Infusion (because of presence of GVHD or major HLA mismatch between donor and patient), as decided by the treating physician.
- •- Patient and donor HLA-A2 positive, patient HA-1 positive, donor HA-1 negative.
- •- WHO performance status of 0, 1 or 2 (see appendix)
- •- 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 IUD) during the course of this trial and for at least three months after the last injection
- •- Informed consent given by patient;Inclusion criteria at time of vaccination (DLI group):
- •Mixed chimerism or persisting disease 8 weeks after DLI
- •No necessity of persistent treatment with high-dose corticosteroids (> 20 mg prednisone a day), chemotherapy or other immunosuppressive drugs.
- •No rapidly progressive disease
- •No GVHD grade 3 or 4
- •No HA-1 specific immune response (defined by <0.2% of total CD8+ cells in first six patients and defined by <1.0% of total CD8+ cells in patients 7-12 if no toxicity >grade II in first six 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 > 0.2%);Inclusion criteria at time of vaccination (non-DLI group):
- •No necessity of persistent treatment with high-dose corticosteroids (> 20 mg prednisone a day), chemotherapy or other immunosuppressive drugs.
- •No rapidly progressive disease
- •No GVHD grade 3 or 4
- •No HA-1 specific immune response (defined by <0.2% of total CD8+ cells in first six patients and defined by <1.0% of total CD8+ cells in patients 7-12 if no toxicity >grade II in first six patients).
排除标准
- •Exclusion criteria for both groups:
- •Life expectation of < 3 months
- •psychological disturbances
- •Severely limited life expectation due to diseases other than the malignancy
- •HIV positivity
研究者
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