jRCTs031220607招募中不适用
Phase II study of salvage haploidentical allogeneic hematopoietic stem cell transplantation using posttransplant cyclophosphamide for engraftment failure (JSCT Salvage PTCy-Haplo)
未提供0 个研究点目标入组 20 人开始时间: 2023年7月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 70age old under（—）
- 性别
- All
入选标准
- •primary engraftment failure after allogeneic hematopoietic stem cell transplantation for hematological disease, primary immunodeficiency, and congenital metabolic disorder
- •any stage and disease status
- •any history of autologous or allogeneic stem cell transplantation
- •no evidence of severe organ dysfunction (ejection fraction >=50, total bilirubin <=2.0, CCr >=30, SpO2 >=90% (O2 <=4L/min)
- •consent to join this study
- •a HLA haploidentical donor is available
排除标准
- •positive anti-HIV antibody
- •active cancer
- •need for vasopressor
- •allergic to cyclophosphamide, melphalan, fludarabine, tacrolimus, and mycophenolate Mofetil
- •need for chemotherapy before protocol therapy
- •concomitant relapse of primary malignancy
- •recurrent engraftment failure
- •presence of donor-specific anti-HLA antibody
- •judgment by physician
结局指标
主要结局
-
Overall survival at 1 year
次要结局
- neutrophil and platelet engraftment rate(30 days)
- incidence and severity of acute and chronic GVHD(180 and 365 days)
- relapse rate(180 and 365 days)
- nonrelapse mortality(180 and 365 days)
- relapse-free survival(180 and 365 days)
- GVHD-free relapse-free survival(180 and 365 days)
- incidence of infection(180 days)
- incidence of non-hematological toxicity graded>=3(100 days)
研究者
相似试验
已完成
1 期
Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin Phase I studyhematological malignancyJPRN-UMIN000009374ational Cancer Center Hospital15
已完成
1 期
Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin (RIC version) Phase IHematological malignancyJPRN-UMIN000011004ational Cancer Center Hospital12
已完成
不适用
Allogeneic hematopoietic stem cell transpalntation using Thymoglobulin for patients with T-cell malignancyT-cell malignancyJPRN-UMIN000015736ational Cancer Center Hospital15
已完成
2 期
Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1HIRCT138706061030N2Tehran University of Medical Sciences10
已完成
不适用
Allogeneic hematopoietic stem cell transplantation for elderly patientsJPRN-UMIN000017744nivesity of Tokyo Hospital, Department of Hematology and Oncology50