Short-term Blinatumomab as a Bridge Therapy for Hematopoietic Stem Cell Transplantation in B-cell Acute Lymphoblastic Leukemia With Low Leukemia Burden
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The goal of this single-arm, prospective study is to test in low-burden B-cell lymphoblastic leukemia (B-ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:
• The efficacy and safety of short-term blinatumomab as a bridging therapy to allo-HSCT in patients with low-burden B-ALL. Participants will take intravenous blinatumomab prior to allo-HSCT with an initial dosage of 8 μg/day. The dosage gradually escalated to 28 μg/day and continued for 5 to 10 days. Dexamethasone 20mg was administered 1 hour before the onset of blinatumomab infusion.
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with B-ALL;
- •patients with age ≥ 16 years;
- •Availability of both pre- and post-transplantation disease status records.
排除标准
- •administration of blinatumomab therapy for more than 14 days;
- •patients with leukemia burden ≥ 10% before initiation of treatment;
- •patients with severe organ dysfunctions before treatment, including myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction, or gastrointestinal dysfunction;
- •patients with central nervous system leukemia.
研究组 & 干预措施
blinatumomab
Blinatumomab was administered via a peripherally inserted central catheter (PICC) with an initial dosage of 8 μg/day. The dosage gradually escalated to 28 μg/day, with a total dose of 175 μg, infused over 5 to 10 days. To mitigate the risk of cytokine release syndrome (CRS), dexamethasone at a dose of 20 mg was administered 12 hours before the onset of blinatumomab infusion. Patients underwent myeloablative conditioning therapy consisting of fludarabine-and-busulfan-based regimen. Peripheral stem cells from HLA-matched sibling donors (MSD), matched unrelated donors (MUD), or haploidentical donors (HID) were reinfused two days after conditioning. Follow-up examinations were scheduled at +1, +2, +3, +4, +6, +9, +12, +18, and +24 months post-transplant.
干预措施: blinatumomab (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 2 years
Progression free survival of this group of patients at the end of 2 years
次要结局
- Cumulative incidence of chronic graft versus host disease (cGVHD)(2 years)
- Overall survival (OS)(2 years)
- Relapse rate(2 years)
- Cumulative incidence of acute graft versus host disease (aGVHD)(Day +100)
研究者
Jie Ji
Principle Investigator
Sichuan University