NCT03320642终止1 期
GRAVITAS-119: A Single-Arm, Open-Label, Phase 1 Study of Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 84
- 试验地点
- 17
- 主要终点
- Proportion of participants with hematologic recovery when itacitinib is added to GVHD prophylaxis treatment
研究概览
简要总结
The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia with no circulating blasts and < 5% blasts in the bone marrow.
- •Subjects with non-Hodgkin lymphoma, including but not limited to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell, or mantle cell lymphoma must have chemosensitive disease at time of transplant. Subjects with Hodgkin lymphoma with chemosensitive disease at the time of transplant.
- •Must be candidates for reduced-intensity conditioning regimens.
- •Must be candidates for peripheral blood stem cell transplants.
- •Karnofsky Performance Status score ≥ 70% or Eastern Cooperative Oncology Group Performance Status score of 0 to
- •Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockcroft-Gault equation.
- •Be willing to avoid pregnancy or fathering children.
排除标准
- •Has previously received an allogenic hematopoietic stem cell transplant.
- •Presence of an active uncontrolled infection.
- •Known HIV infection.
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation.
- •Prior malignancies.
- •Severe organ dysfunction.
- •Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment.
- •Currently breastfeeding.
- •Known allergies, hypersensitivity, or intolerance to any of the study medications.
- •Receipt of live (including attenuated) vaccines during the study, or anticipation of need for such a vaccine during the study.
- •History of primary idiopathic myelofibrosis or any severe marrow fibrosis that would prolong neutrophil engraftment to > 28 days after transplant.
- •Post-transplant maintenance therapy for the hematologic malignancy or plans to initiate maintenance therapy during study treatment.
研究组 & 干预措施
Itacitinib + Calcineurin Inhibitor (CNI) -Based Interventions
Experimental
Itacitinib in combination with a CNI-based intervention.
干预措施: Itacitinib (Drug)
Itacitinib + Calcineurin Inhibitor (CNI) -Based Interventions
Experimental
Itacitinib in combination with a CNI-based intervention.
干预措施: Calcineurin inhibitor (Drug)
结局指标
主要结局
Proportion of participants with hematologic recovery when itacitinib is added to GVHD prophylaxis treatment
时间窗: Day 28
Hematologic recovery defined as demonstrating both neutrophil recovery (ANC ≥ 500/mm\^3 for 3 consecutive measurements) and platelet recovery (platelet count ≥ 20,000/mm\^3 with no requirement for platelet transfusion in the preceding 3 days).
次要结局
- GVHD relapse-free survival rate(Days 100, 180 and 365)
- Transplant-related mortality(Up to 1 year)
- Median time to neutrophil and platelet engraftment(Up to Day 28)
- Donor Chimerism(Up to Day 28)
- Infection rate(Up to 1 year)
- Overall survival(Up to 1 year)
- Relapse-free survival(Up to 1 year)
- Participants with Grade 3-5 treatment-emergent adverse events (TEAEs)(Up to approximately 200 days)
- Percentage of participants who achieve neutrophil and platelet engraftment(Up to Day 28)
- Proportion of subjects who are diagnosed with Grade II-IV aGVHD, by each grade and by Grade III/IV(Days 100 and Days 180)
- Proportion of subjects who are diagnosed with cGVHD by grade (mild, moderate, or severe)(Up to 1 year)
研究者
研究点 (17)
Loading locations...
相似试验
终止
2 期
GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host DiseaseChronic Graft-versus-host DiseaseNCT03584516Incyte Corporation155
已完成
1 期
Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese SubjectsAcute Graft-versus-host DiseaseNCT03497273Incyte Corporation14
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
进行中（未招募）
1 期
A study evaluating safety and efficacy of itacitinib and corticosteroids as initial treatment of chronic graft versus-host diseaseModerate or severe cGVHDMedDRA version: 20.1Level: PTClassification code 10066261Term: Chronic graft versus host diseaseSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10072160Term: Chronic graft versus host disease in liverSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10072158Term: Chronic graft versus host disease in intestineSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10072159Term: Chronic graft versus host disease in skinSystem Organ Class: 10021428 - Immune system disordersEUCTR2018-001606-29-FIIncyte Corporation401