NCT03497273已完成1 期
An Open-Label Single-Arm Phase 1 Study Evaluating Safety of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 17
- 主要终点
- Number of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of itacitinib in combination with corticosteroids in Japanese subjects with Grades II to IV acute graft-versus-host disease (aGVHD).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese; subject was born in Japan and has not lived outside of Japan for a total of > 10 years, and subject can trace maternal and paternal Japanese ancestry.
- •Has undergone 1 allo-hematopoietic stem cell transplant (HSCT) from any donor and source (unrelated, sibling, haploidentical donors with any matching) using bone marrow, peripheral blood or cord blood for hematologic malignancies. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
- •Clinically suspected Grades II to IV aGVHD as per Mount Sinai Acute GVHD International Consortium (MAGIC) criteria, occurring after allo-HSCT and any anti-GVHD prophylactic medication.
- •Evidence of myeloid engraftment (eg, absolute neutrophil count [ANC] ≥ 0.5 × 10^9/L for 3 consecutive assessments if ablative therapy was previously used). Use of growth factor supplementation is allowed.
- •Female subjects should agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration if of childbearing potential or must have evidence of non-childbearing potential by fulfilling protocol-defined criteria at screening.
排除标准
- •Has received more than 1 allo-HSCT.
- •Has received more than 2 days of systemic corticosteroids for aGVHD.
- •Presence of GVHD overlap syndrome.
- •Presence of an active uncontrolled infection (defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection; persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection).
- •Known human immunodeficiency virus infection.
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. For subjects with negative HBsAg and positive total hepatitis B core antibody and for subjects who are positive for HCV antibody, HBV DNA and HCV RNA must be undetectable upon testing.
- •Evidence of relapsed primary disease or having been treated for relapse after the allo-HSCT was performed.
- •Any corticosteroid therapy (for indication other than GVHD) at doses > 1 mg/kg per day methylprednisolone or equivalent within 7 days of enrollment.
- •Severe organ dysfunction unrelated to underlying GVHD, including the following:
- •Cholestatic disorders or unresolved veno-occlusive disease of the liver.
- •Clinically significant or uncontrolled cardiac disease.
- •Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.
- •Serum creatinine > 2.0 mg/dL or creatinine clearance < 40 mL/min measured or calculated by Cockroft-Gault equation
- •Received Janus kinase (JAK) inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.
- •Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
研究组 & 干预措施
Itacitinib + corticosteroids
Experimental
Itacitinib administered in combination with corticosteroids.
干预措施: Itacitinib (Drug)
Itacitinib + corticosteroids
Experimental
Itacitinib administered in combination with corticosteroids.
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events
时间窗: Up to approximately 12 months
Defined as any adverse event reported for the first time or worsening of a pre-existing event after first dose of study drug.
次要结局
- Time to response(Up to approximately 12 months)
- Malignancy relapse rate(Up to approximately 12 months)
- Nonrelapse mortality(Up to approximately 12 months)
- Duration of response(Up to approximately 12 months)
- Failure-free survival(Up to 6 months)
- Overall survival(Up to approximately 12 months)
- Cmax of INCB039110(Up to approximately 1 month)
- Cl/F of INCB039110(Up to approximately 1 month)
- Objective response rate(Up to 100 days)
研究者
研究点 (17)
Loading locations...
相似试验
已完成
1 期
An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung CancerLung CancerNCT02917993Incyte Corporation59
已完成
1 期
A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell LymphomaLymphomaNCT02760485Incyte Corporation33
终止
1 期
Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host DiseaseSteroid Refractory GVHDGraft Vs Host DiseaseNCT04070781Columbia University1
进行中（未招募）
1 期
Itacitinib + Everolimus in Hodgkin LymphomaClassical Hodgkin LymphomaNCT03697408University of Pennsylvania23
已完成
2 期
A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With MyelofibrosisMPN (Myeloproliferative Neoplasms)NCT03144687Incyte Corporation23