Pre-emptive Therapy With Low-dose Decitabine for Patients With Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent graft versus host disease (GVHD) is the major complications. In this single arm prospective study, the investigator evaluate the effect and safety of low-dose decitabine alone or with DLI in patients with decreased donor chimerism after allo-HSCT.
详细描述
Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent GVHD is the major complications. In this single arm prospective study, the investigator plan to evaluate the effect and safety of low-dose decitabine treatment alone in patients with decreased donor chimerism after allo-HSCT. The investigators expect an overall response rate of 80% without serious toxicity such as grade III-IV aGVHD, ext cGVHD and lethal infection event associated with low-dose decitabine (LD-DAC) treatment. In case of donor chimerism decreasing, 5-day low-dose decitabine (5mg/m2) will given every 6 to 8 weeks until full donor chimerism is achieved (>98%). Fast withdraw of immuno-suppression or stop of immunosupression is not carried out in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients after allogeneic stem cell transplantation
- •decreasing of donor chimerism to less than 97%
- •providing inform consent
排除标准
- •patients with documented relapse disease
- •patients with documented positive MRD+ (>0.1% via flowcytometry or PCR)
- •patients with active infection or grade III-IV GVHD
研究组 & 干预措施
Treatment
The peripheral and bone marrow T cell and mono nucleated cell chimerism will be closely followed-up. In case of decreasing donor chimerism, patients will receive low-dose decitabine with 5mg/m2 daily for 5 days every 6-8 weeks until the chimerism recovered to full donor type (>98%).
干预措施: Decitabine (Drug)
结局指标
主要结局
Complete response rate
时间窗: 6 months after initiation of treatment
Documentation \>98% donor chimerism of T cells or mononuclear cell in either peripheral blood or bone marrow
次要结局
- Overall response(6 months after initiation of treatment)
- relapse rate(12 months after initiation of treatment)
- incidence of moderate to severe chronic GVHD(12 months after initiation of treatment)
- engraftment failure(12 months after initiation of treatment)
- survival rate(12 months after initiation of treatment)
- incidence of grade III-IV aGVHD(12 months after initiation of treatment)
研究者
Jiong HU
Head, BMT program, Deputy director, Department of Hematology, Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine