JPRN-jRCTs031180435招募中3 期
A randomized trial comparing conventional GVHD prophylaxis vs. anti-thymocyte globulin-combined GVHD prophylaxis in HLA 1-locus mismatched unrelated bone marrow transplantation for patients with hematological malignancies. - A randomized trial of ATG in HLA 1-locus mismatched unrelated bone marrow transplantation
Kanda Yoshinobu0 个研究点目标入组 130 人开始时间: 2019年3月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
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
- >= 16age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •1. Patients who have one of the following disease statuses
- •(a) AML: any stages with <=50% of blasts in BM and PB
- •(b) ALL: any stages with <=50% of blasts in BM and PB
- •(c) ATL: any stages with <=50% of malignant cells in BM and PB
- •(d) CML: stages with either >=CP2, AP, BP, or failure to 2 types of TKIs, with <=50% of blasts in BM and PB
- •(e) MDS: IPSS, intermediate-II or high; IPSS-R,intermediate or high or very high;WPSS, high or very high; relapse after remission
- •(f) NHL: patients who have one of the following statuses
- •(1)low-grade lymphoma: chemo-refractory, relapse after autologous SCT, CR or PR after >=3 lines of chemotherapy
- •(2) intermediate-grade lymphoma: PR,>=CR2
- •(3) high-grade lymphoma: PR, CR
- •(g) Hodgkin lymphoma: PR, >=CR2
- •2. Patients who are 16 to 70 years old
- •3. Patients who do not have an available HLA-A, -B, -DR matched related donor
- •4. Patients who do not have an HLA-A, -B, -C, -DRB1 8/8 allele matched unrelated donor candidate, or it takes long time for donor coordination because of lack of allele information, etc, despite many HLA-A, -B, -DR antigen matched donor candidates.
- •5. Patients who have an unrelated bone marrow donor with an HLA-1 locus mismatch at HLA-A, -B, -C, and -DRB1 locus.
- •6. Donors who are 20 to 55 years old
- •7. Patients with ECOG performance status of 0, 1, or 2
- •8. Patients whose major organ functions (heart, lung, liver, kidney) are preserved and who meet all of the following criteria
- •(a) Ejection fraction>=40%
- •(b) SaO2>=94% on room air or SpO2>=94% on room air
- •(c) Pulmonary function test: %VC>=70%, FEV1.0%>=70%
- •(d) Serum total bilirubin <=2.0 mg/dl and serum AST<=5 x UNL
- •(e) Ccr >=30ml/min
排除标准
- •1. Presence of donor-specific HLA antibodies
- •2. Patients with HBs antibody positive
- •3. Patients with HIV antibody positive
- •4. Patients with serious mental disorder who are likely unable to participate in the study
- •5. Patients who are pregnant, nursing, or possibly pregnant
- •6. Patients with coexistence of malignancy
- •7. Patients with poorly controlled active infection
- •8. Patients who are allergic to ATG
- •9. Prior history of allogeneic hematopoietic cell transplantation within 1 year
研究者
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