Blinatumomab Sequential Donor Lymphocyte Infusion in Acute B Lymphocytic Leukemia Observation of Therapeutic Effect in Patients With Recurrence After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
B-ALL patients received regular follow-up after allogeneic hematopoietic stem cell transplantation, and in case of recurrence, they were given Blinatumomab.
Anti-treatment was followed by DLI, and the second course was performed 1-2 months after DLI.
Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment.
(MNC infusion is about 5×10^7/kg~1×10^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10^7/kg~1×10^8/kg). Objective To observe and analyze the efficacy and side effects of Blinatumomab followed by donor lymphocyte infusion in patients with relapsed acute B lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation in our hospital.
详细描述
Patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital and received sequential donor lymphocyte infusion （DLI） treatment after relapse. The patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital from September 2023 to December 2026 and received sequential donor lymphocyte infusion （DLI） treatment after relapse were enrolled.
- Age ≤65 years old
- Stable vital signs
- No severe infection
- No grade II-IV graft-versus-host disease
- No organ failure
Exclusion criteria
- Age >65 years old
- Unstable vital signs
- Complicated with severe infection
- Complicated with grade II-IV graft-versus-host disease
- Organ failure such as heart, liver, kidney, etc.
- Complicated with central nervous system leukemia
- Drug allergy to the treatment regimen Treatment regimen B-ALL patients were regularly followed up after allogeneic hematopoietic stem cell transplantation. When relapse occurred, Blinatumomab was given sequentially after DLI, and the second course of treatment was conducted 1-2 months after DLI.
MRD-positive patients were given Blinatumomab 28μg×5-15 days, followed by DLI treatment （infusion of MNC is about 5×10^7/kg~1×10^8/kg）.
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤65 years old
- •Stable vital signs
- •No severe infection
- •There was no grade II-IV graft-versus-host disease
- •No organ failure
排除标准
- •Age > 65 years old
- •Unstable vital signs
- •Complicated with severe infection
- •Combined with grade Ⅱ-Ⅳ graft-versus-host disease
- •Heart, liver, kidney and other organ failure
- •Complicated with central nervous system leukemia
- •Allergies to medications in the treatment regimen
研究组 & 干预措施
Blinatumomab followed by donor lymphocyte infusion
Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment.
(MNC infusion is about 5×10^7/kg~1×10^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10^7/kg~1×10^8/kg).
干预措施: Blinatumomab (Drug)
结局指标
主要结局
Disease-free survival
时间窗: three years
Disease-free survival time after treatment for relapsed patients
Overall survival
时间窗: three years
Survival time of patients with recurrence after treatment
次要结局
- Incidence of acute/chronic graft-versus-host disease （GVHD）(2 weeks later)
- incidence of cytokine release syndrome （CRS）(2 weeks later)
- hematological adverse reactions Incidence rate(2 weeks later)
研究者
Suping ZHANG
visiting staff
The First Affiliated Hospital of Zhengzhou University