NCT03146468Unknown2 期
Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Graft versus host disease
研究概览
简要总结
This is a prospective study of the safety and efficacy of nivolumab for the treatment of relapsed or residual haematological malignancies after allogeneic stem cell transplantation (alloSCT).
Eligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. The primary objective is to evaluate the incidence, severity and treatment responsiveness of GVHD following nivolumab treatment post-alloSCT.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior allogeneic stem cell transplant for a haematological malignancy
- •Confirmed relapse of haematological malignancy or persistent disease post-alloSCT
- •Immunosuppression cessation for minimum of 2 weeks
- •Life expectancy > 2 months
- •ECOG performance status 0-2
- •Greater than or equal to 30% CD3+ donor chimerism
- •Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 40mL/min
- •AST and ALT ≤ 3 times upper limit of normal
- •Total bilirubin ≤ 1.5 times upper limit of normal (except patients with Gilbert Syndrome)
- •Signed written informed consent
排除标准
- •Current evidence of any grade of GVHD
- •Prior history of grade 2 or higher acute GVHD
- •Moderate chronic GVHD within the previous 6 months or any prior history of severe chronic GVHD
- •Active, known or suspected autoimmune disease (excluding vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger)
- •Positive hepatitis B virus surface antigen
- •Positive hepatitis C virus antibody
- •Known human immunodeficiency virus infection
研究组 & 干预措施
Nivolumab treatment arm
Experimental
Nivolumab injection 3mg/kg intravenously every 2 weeks
干预措施: Nivolumab Injection (Drug)
结局指标
主要结局
Graft versus host disease
时间窗: 48 weeks
Cumulative incidence of graft versus host disease
次要结局
- Overall response rate(48 weeks)
研究者
研究点 (1)
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