Salavge Chemotherapy With Cladribine, Cytarabine and Mitoxantrone Followed by Mobilized Peripheral Stem Cell Infusion From the Original Donor for Relapsed Patients After Allogeneic Stem Cell Transplantation: Phase I/II Study
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- complete remission (Bone marrow)
研究概览
简要总结
For acute leukemia patients with early relapse after allogeneic stem cell transplantation, the overall outcome is poor. In this study, we evaluate the treatment outcome and safety of chemotherapy with Cladribine, cytarabine and mitoxantrone followed by peripheral stem cell support from the original donor.
详细描述
For acute leukemia patients experienced relapse 6 months or less after allogeneic stem cell transplantation, the overall outcome is poor. In this study, we design a treatment protocol aiming to achieve complete remission for this high-risk group of patients with chemotherapy consisting of Cladribine (5mg/m2), cytarabine (1.5g/m2) and mitoxantrone （10mg/m2）for 5 days followed by infusion of mobilized peripheral stem cell from the original donor. For patients who failed to achieved remission,a second cycles will be given. For patients who achieved remission, the post-remission therapy is open depend on patient's intent: consolidation with one more cycle, second allo-HSCT with different donor or continuous DLI.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with acute leukemia relapsed within 6 months after previous allo-HSCT
- •no active GVHD
- •mobilized PBSC from the original donor available
排除标准
- •ECOG >=3
- •liver function/renal function damage (over 2 X upper normal range)
- •active infection including CMV and EBV
研究组 & 干预措施
CLAM|PBSC
CLAM chemotherapy with mobilized PBSC infusion: Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5
干预措施: CLAM+PBSC (Drug)
结局指标
主要结局
complete remission (Bone marrow)
时间窗: 30 days after treatment
bone marrow aspiration performed on D30 after treatment. In case of less 5% blast with fully recovery of peripheral blood count is considered as CR. In case of less than 5% blast without fully recovered CBC is considered as CRi
次要结局
- survival(6 months)
- GVHD (clinical evaluation and grading)(6 months)
- chimerism (bone marrow)(30 days after treatment)
- relapse (bone marrow)(6 months)
- non-relapse mortality(6 months)
研究者
Jiong HU
Head, Blood and Marrow Transplantation Program, Chief Physician
Shanghai Jiao Tong University School of Medicine