Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplant Blinatumomab Maintenance Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- B cell receptor expression
研究概览
简要总结
The goal of this observation study is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:
• Effect of post-transplant blinatumomab treatment on immune reconstitution after transplantation.
Participants will undergo immune repertoire sequencing(IR-SEQ) before blinatumomab treatment, 6 months and 1 year after transplantation.
Researchers will compare patients who don't receive blinatumomab treatment after transplantation to see if TCR or BCR expression differs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Aged 16-65 years old
- •KPS score > 60 or ECOG score 0-2
- •diagnosed as B-ALL, a) disease status > CR1 at the time of transplantation; Patients beyond CR1 or induction failure could be free of minimal residual disease (MRD). b) any residual disease, defined as >0.01% leukemic cells by flow cytometry, BCR-ABL transcript ≥ 1 in 10000 by PCR, or high-risk genetic abnormality
- •neutrophil count ≥0.5×10^9/L and platelet count ≥20×10^9/L
- •creatinine clearance ≥30ml/min; Alanine aminotransferase/aspartate aminotransferase ≤5 times the upper detection limit; Total bilirubin ≤3 times the upper limit of detection
- •The first initiation of berintuzumab therapy was within 60-100 days after transplantation
- •without evidence of active acute graft-versus-host disease (aGvHD)
排除标准
- •With serious basic diseases of important organs, such as myocardial infarction, chronic cardiac insufficiency, decompensated liver dysfunction, renal dysfunction, gastrointestinal dysfunction, etc
- •With clinically uncontrolled active infection
- •Patients with central nervous system involvement before transplantation
- •Poor graft function (PGF) occurred after allo-HSCT
- •Patients with second allogeneic transplantation
研究组 & 干预措施
Blin-PTCY
Post-transplant cyclophosphamide is used as graft versus host disease (GvHD) prophylaxis. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation.
干预措施: blinatumomab (Drug)
Blin-ATG
Antithymocyte globulin is used as graft versus host disease (GvHD) prophylaxis. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation.
干预措施: blinatumomab (Drug)
结局指标
主要结局
B cell receptor expression
时间窗: before blinatumomab treatment , 6 months and 1 year
B cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ)
T cell receptor expression
时间窗: before blinatumomab treatment , 6 months and 1 year
T cell receptor expression measured by Immune Repertoire sequencing(IR-SEQ)
次要结局
- T cell subsets count(before blinatumomab treatment , 6 months and 1 year)
研究者
Jie Ji
Principle Investigator
Sichuan University