Blinatumomab Prevents the Recurrence of Relapsed or Refractory Acute Lymphoblastic Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Singlecentered, Single-arm, Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 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 phase I/II clinical trial 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:
• The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R/R ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.
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
- •B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT;
- •Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF);
- •KPS > 60 or ECOG 0-2;
- •The expected survival time is more than 3 months;
- •Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator;
- •Reach the standard of hematopoietic reconstitution (neutrophil count
- •≥ 0.5×10^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L within 45 days after transplantation;
- •No central nervous system involvement or clinical symptoms after transplantation;
- •Those who have no serious functional damage to important organs of the body;
- •Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
- •Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.
排除标准
- •Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
- •Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
- •Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;
- •Poor graft function (PGF) occurred after allo-HSCT;
- •Combined with other malignant tumors and require treatment;
- •Active GVHD;
- •Have a history of allergy to Chidamide;
- •Pregnant or lactating females;
- •Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
- •Patients with active chronic hepatitis B or active hepatitis C;
- •History of prolonged QT syndrome;
- •Patients considered by other researchers to be unsuitable for this study
研究组 & 干预措施
blinatumomab
Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.
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 year
100 day adverse events (AE)
时间窗: Day +100
non-hematologic adverse events
次要结局
- Overall survival (OS)(2 years)
- Relapse rate(2 years)
- Cumulative incidence of chronic graft versus host disease (cGVHD)(2 years)
- Non-relapse mortality (NRM)(6 months)
- Cumulative incidence of acute graft versus host disease (aGVHD)(Day +100)
研究者
Jie Ji
Principle Investigator
Sichuan University