NL-OMON37016已完成2 期
Administration of leukemia-reactive donor T cells after allogeneic stem cell transplantation or donor lymphocyte infusion to patients with persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement - Leukemia reactive donor T cells
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
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
- •- allo-SCT patient with a sibling or unrelated stem cell donor matched for at least HLA-A, -B, -C, and -DR alleles (8/8).;
- •- Age 18-75 years;
- •- WHO performance score 0-2;
- •- Persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement at least 3 months after allo-SCT or DLI;
- •- Possibility to collect > 5 x 10^7 mononuclear cells containing > 25% malignant B cells from blood or bone marrow of patient, or availability of patient malignant B cells cryopreserved at a GMP-facility;
- •- Donor willing to donate PBMC, or cryopreserved donor PBMC available in an amount of >=1 x 10^9 MNC/ total;
- •- Written informed consent
排除标准
- •- Life expectation <3 months
- •- End stage irreversible multi-system organ failure
- •- Acute GvHD overall grade >= II
- •- Treatment with corticosteroids in an equivalent dose of >0.5 mg/kg prednisone
- •- Pregnant or lactating women
- •- Severe psychological disturbances
研究者
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