jRCT2080223697已完成3 期
A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory chronic graft vs host disease after allogeneic stem cell transplantation (REACH3)
Novartis Pharma. K.K.1 个研究点目标入组 324 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, open label, multi center
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 12age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female patients =>12 years old at the time of signing the ICF
- •Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible
- •Evident myeloid and platelet engraftment: Absolute neutrophil count (ANC) > 1000/mm3 and platelet count > 25,000/ mm3
- •Patients with clinically diagnosed moderate to severe cGvHD according to NIH Consensus Criteria (Jagasia 2015) prior to randomization:
- •Moderate cGvHD: At least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1
- •Severe cGvHD: at least 1 organ with a score of 3, or lung score of 2 or 3
- •Patients currently receiving systemic or topical corticosteroids for the treatment of cGvHD for a duration of < 12 months prior to Cycle 1 Day 1 (if applicable), and have a confirmed diagnosis of steroid refractory cGvHD defined per 2014 NIH consensus criteria (Martin 2015) irrespective of the concomitant use of a calcineurin inhibitor, as
- •A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for at least 1 week (or equivalent), OR
- •Disease persistence without improvement despite continued treatment with prednisone at >0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent), OR
- •Increase to prednisolone dose to >0.25 mg/kg/day after two unsuccessful attempt to taper the dose (or equivalent)
- •Patient must accept to be treated with only one of the following BAT options on Cycle 1 Day
- •(Additions and changes are allowed during the course of the study, but only with BAT from the following BAT options): extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, ibrutinib
排除标准
- •Patients who have received two or more systemic treatments for cGvHD in addition to corticosteroids +/- CNI for cGvHD
- •Patients that transition from active aGvHD to cGvHD without tapering off corticosteroids +/- CNI and any systemic treatment
- •Patients who were treated with prior JAK inhibitors for aGvHD; except when the patient achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1
- •Failed prior alloSCT within the past 6 months from Cycle 1 Day 1
- •Patients with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed
- •SR-cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Patients who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible
- •Any corticosteroid therapy for indications other than cGvHD at doses >1 mg/kg/day methylprednisolone or equivalent within 7 days of Cycle 1 Day 1
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Cycle 7 Day 1 visit
To compare the efficacy of ruxolitinib vs. Investigator choice Best Available Therapy (BAT) in patients with moderate or severe SR-cGvHD
次要结局
未报告次要终点
研究者
研究点 (1)
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