A Single-arm, Single-center Trial of Prophylactic Tocilizumab for Acute GVHD Prevention After Haploidentical HSCT.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Cumulative incidence of grade II-IV acute graft-versus-host disease
研究概览
简要总结
A single-arm trial using Tocilizumab for acute GVHD prophylaxis after haploidentical HSCT.
详细描述
This study will enroll haploidentical HSCT patients with high risk for acute GVHD. Tocilizumab (8mg/kg) will be added to the conventional acute GVHD prophylaxis regime (CsA+Methotrexate(MTX)+low dose mycophenolate mofetil(MMF)+ATG) on day -1 of transplant. The previous patients will be used as control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematological malignancies in complete remission (CR) who are eligible and planned for haploidentical HSCT. The donor specific antibody is negative
- •Patient age 16-60 years
- •Mother donor, or female donor (age >50) for female-male transplant
- •Eastern Cooperative Oncology Group (ECOG) performance status < 2
- •Creatinine clearance rate > 60 mL/min (estimate by Cockcroft-Gault Equation)
- •alanine transaminase (ALT) and aspartate aminotransferase (AST)≤ 2.5×upper limit of normal (ULN), and total bilirubin ≤ 1.5×ULN （upper limit of normal, ULN）
- •Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography
- •Acceptation to sign the informed consent
排除标准
- •History of previous HSCT
- •Present active infection (including bacterial, virus or fungal)
- •History of Tocilizumab infection
- •History of inflammatory bowel disease
- •History of demyelinating disease
- •Patients who are HIV-positive, or with uncontrolled chronic hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV) infections
- •Women who are pregnant (β-chorionic gonadotropin+) or breast feeding
- •Refusal to sign the informed consent
研究组 & 干预措施
Tocilizumab cohort
Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.
干预措施: Cytarabine (Drug)
Tocilizumab cohort
Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.
干预措施: Busulfan (Drug)
Tocilizumab cohort
Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.
干预措施: Cyclophosphamide (Drug)
Tocilizumab cohort
Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.
干预措施: Me-CCNU (Drug)
Tocilizumab cohort
Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.
干预措施: Rabbit antithymocyte globulin (Drug)
Tocilizumab cohort
Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.
干预措施: Tocilizumab (Drug)
Tocilizumab cohort
Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.
干预措施: Allogeneic HSCT (Procedure)
Tocilizumab cohort
Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.
干预措施: Cyclosporin A (Drug)
Tocilizumab cohort
Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.
干预措施: Mycophenolate Mofetil (Drug)
Tocilizumab cohort
Each patient receives Tocilizumab (8 mg/kg, i.v.) on day -1 added to conventional acute GVHD prophylaxis regimen (CsA+MTX+low-dose MMF+ATG) of haploidentical HSCT.
干预措施: MTX (Drug)
结局指标
主要结局
Cumulative incidence of grade II-IV acute graft-versus-host disease
时间窗: 100 days
Date of symptom onset, maximum clinical grade, and dates and types of treatment will be recorded. Dates of symptom onset of grade II-IV acute graft-versus-host disease (aGVHD) will be recorded. The aGVHD score of each affected organ will be recorded.
Cumulative incidence of non grade II-IV acute graft-versus-host disease survival
时间窗: 100 days
All patients will be tracked from Day 0 to date of grade II-IV acute graft-versus-host disease (aGVHD) onset. Patients who did not present grade II-IV aGVHD or died will be censored at the last date they were assessed and deemed free of grade II-IV aGVHD.
次要结局
- Cumulative incidence of engraftment(100 days)
- Cumulative incidence of infections(2 years)
- Overall survival (OS)(2 years)
- Progression-free survival (PFS)(2 years)
- Cumulative incidence of transplant-related nonrelapse mortality (NRM)(2 years)
- Cumulative incidence of disease relapse or progression(2 years)
研究者
Yi Luo
Clinical Professor
First Affiliated Hospital of Zhejiang University