JPRN-jRCTs031180237已完成1 期
HLA-mismatched allogeneic hematopoietic stem cell transplantation for high-risk advanced hematological disease with the adjustments of immunosuppressants and low-dose alemtuzumab
Kanda Yoshinobu0 个研究点目标入组 27 人开始时间: 2019年3月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
研究概览
简要总结
The rate of the achievement of primary outcome measure was more than 80%, but the RR at 1 year was high. Most patients had uncontrollable, non-remission disease, and in addition, many patients had a history of previous allogeneic transplantation. These affected outcomes a lot, but we need to decrease a relapse rate by inducing new methods, such as the further reduction of immunosuppressants after transplantation and donor lymphocyte infusion (DLI) at the early phase after transplantation.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •1.Patients who do not have an available HLA-matched or one locus-mismatched related donor.
- •2.Patients who have a two- or three-locus-mismatched haploidentical related donor in good condition. (This donor should precede an HLA-matched or one locus-mismatched related donor according to the disease status.)
- •3.Patients who do not have an HLA-matched or one allele-mismatched unrelated donor, or patients whose disease status preclude time-consuming donor coordination.
- •4.Patients with high-risk advanced hematological disease. Leukemia and malignant lymphoma in non-remission, MDS with more than 20% of blast, and relapsed disease after allogeneic transplantation are included in high-risk group.
- •5.Patients who are 16 to 70 years old
- •6.Patients in performance status of 0 or 1.
- •7.Patients whose major organ functions are preserved.
排除标准
- •1.Patients with poorly controlled active infection.
- •2.Patients with coexistence of malignancy.
- •3.Patients who are pregnant or nursing.
- •4.Patients with serious mental disorder.
- •5.Patients with HIV antibody positive.
- •6.Patients who are allergic to drugs used in conditioning regimen or GVHD prophylaxis.
研究者
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