A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse events
研究概览
简要总结
To determine if Itacitinib in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Have undergone first allo-HSCT from any donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative transplants are eligible.
- •Clinically suspected Grades IIB to IVD acute GVHD as per modified MN-CIBMTR criteria, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program.
- •Subjects may, but are not required to, have previously received corticosteroids for acute GVHD:
- •Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
排除标准
- •Has received more than 1 hematopoietic stem cell transplantation.
- •Has progressed on more than 2 prior treatment regimens for acute GVHD.
- •Presence of an active uncontrolled infection.
- •Subjects with relapsed primary disease, or subjects who have been treated for relapse after the allogeneic hematopoietic stem-cell transplantation (allo-HSCT) was performed.
- •Inadequate recovery from toxicity and/or complications from the prior allo-HSCT.
- •Any corticosteroid therapy (for indications other than GVHD) at doses > 1 mg/kg per day methylprednisolone or equivalent within 7 days of randomization.
- •Previously received JAK inhibitor therapy for any indication.
研究组 & 干预措施
Itacitinib (200 mg)
Itacitinib (200 mg) + prednisone or methylprednisolone (corticosteroids)
干预措施: Itacitinib (200 mg) (Drug)
Itacitinib (200 mg)
Itacitinib (200 mg) + prednisone or methylprednisolone (corticosteroids)
干预措施: prednisone or methylprednisolone (corticosteroids) (Drug)
Itacitinib (300 mg)
Itacitinib (300 mg) + prednisone or methylprednisolone (corticosteroids)
干预措施: Itacitinib (300 mg) (Drug)
Itacitinib (300 mg)
Itacitinib (300 mg) + prednisone or methylprednisolone (corticosteroids)
干预措施: prednisone or methylprednisolone (corticosteroids) (Drug)
结局指标
主要结局
Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse events
时间窗: First dose of study drug to 30 days after the last dose of study drug
次要结局
- Maximum Observed Plasma Concentration (Cmax) of the two treatment groups Itacitinib(Day 1 and Day 7)
- Time to Reach the Maximum Plasma Concentration (Tmax) of the two treatment groups Itacitinib(Day 1 and Day 7)
- Area Under the Plasma Concentration-time Curve (AUC) of the two treatment groups Itacitinib(Day 1 and Day 7)
- Overall Response Rate (ORR)(Days 14, 28, 56 and 100)
- Minimum observed plasma concentration (Cmin) of the two treatment groups Itacitinib(Day 1 and Day 7)