JPRN-jRCTs031180238已完成2 期
HLA-mismatched allogeneic hematopoietic stem cell transplantation for standard-risk advanced hematological disease using low-dose alemtuzumab
Kanda Yoshinobu0 个研究点目标入组 12 人开始时间: 2019年3月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
The primary outcome measure of this study was DFS at 1 year, but it was below 50%, which was DFS at 1 year in the previous study using alemtuzumab. In this study, MDS with complex karyotype was included as a standard risk, and such patients relapsed. Risk stratification should be reconsidered. NRM was in an acceptable range. The improvements to decrease the RR are needed, such as the reduction of methotrexate dose based on the protocol which had used in high-risk patients.
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.
- •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 standard-risk advanced hematological disease. High-risk acute leukemia, advanced CML, refractory malignant lymphoma, advanced MDS, acute or lymphoma type ATLL, advanced IPF or refractory severe aplastic anemia are regarded as advanced hematological disease, and in advanced disease, leukemia and malignant lymphoma in remission, MDS, IPF or severe aplastic anemia are included in stndard-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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