EUCTR2018-003296-35-SI进行中（未招募）1 期
A Phase II open-label, single-arm, multi-center study of ruxolitinib added to corticosteroids in pediatric subjects with moderate and severe chronic graft vs. host disease after allogeneic stem cell transplantation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female subjects age =28 days and <18
- •years at the time of informed consent.
- •Subjects who have undergone alloSCT from any
- •donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of myeloablative or reduced intensity conditioning are eligible.
- •Subjects with diagnosed moderate to severe
- •cGvHD according to NIH 2014 Consensus Criteria
- •(Section 16.2) prior to Cycle 1 Day 1. Other possible
- •diagnoses for clinical symptoms supporting cGvHD
- •diagnoses must be excluded (e.g., infection, drug side effects, malignancy). Subjects must be either:
- •o Treatment-naive cGvHD subjects that have not
- •received any prior systemic treatment for cGvHD
- •except for a maximum 72h of prior systemic
- •corticosteroid therapy of methylprednisolone or
- •equivalent after the onset of chronic GvHD. Subjects
- •are allowed to have received prior systemic treatment for cGvHD prophylaxis (as long as the prophylaxis was started prior to the diagnosis of cGvHD).
- •o Steroid-refractory moderate to severe cGvHD as
- •per institutional criteria;or per physician decision in case institutional
- •criteria are not available, and still receiving systemic
- •corticosteroids for the treatment of cGvHD for a
- •duration of <18 months prior to Cycle 1 Day 1. In case the corticosteroids were interrupted due to response,
- •the duration of < 18 months applies to the last period of corticosteroid use.
- •Additional inclusion criteria as per fulll protocol may apply.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 42
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •SR-cGvHD subjects with a prior cGvHD
- •treatment with a JAK1- or a JAK2- or a JAK1/2-inhibitor, except when the subject achieved
- •complete or partial response and has been off JAK
- •inhibitor treatment for at least 4 weeks prior to Cycle Day 1 or up to 5 times the half-life of the prior JAK inhibitor, whichever is longer.
- •* Subjects who initiated systemic calcineurin
- •inhibitors (CNI; cyclosporine or tacrolimus) within 3
- •weeks prior to start of ruxolitinib on Cycle 1 Day 1.
- •Note: systemic CNI are allowed when initiated > 3
- •weeks from start of ruxolitinib.
- •Failed prior alloSCT within the past 6 months
- •Significant respiratory disease including subjects
- •who are on mechanical ventilation or who have a
- •resting oxygen saturation < 90% by pulse-oximetry on room-air.
- •Impairment of gastrointestinal (GI) function
- •(unrelated to GvHD) or GI disease (unrelated to
- •GvHD) that may significantly alter the absorption of
- •oral ruxolitinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection),
- •Cholestatic disorders, or unresolved sinusoidal
- •obstructive syndrome/veno-occlusive disease of the
- •liver (defined as persistent bilirubin abnormalities not attributable to cGvHD and ongoing organ dysfunction)
- •Presence of clinically active uncontrolled
- •infection including significant bacterial, fungal, viral or parasitic infection requiring treatment.
- •Known human immunodeficiency virus (HIV)
- •Evidence of uncontrolled hepatitis B virus (HBV)
- •or hepatitis C virus (HCV) based on assessment done
- •by Investigator or delegate.
- •Known allergies, hypersensitivity, or intolerance
- •to any of the study medications, excipients, or similar compounds.
- •History of bone disorders such as osteogenesis
- •imperfecta, rickets, renal osteodystrophy,
- •osteomyelitis, osteopenia, fibrous dysplasia,
- •osteomalacia etc. prior to the underlying diagnosis
- •which resulted in the alloSCT.
- •History of endocrine or kidney related growth
- •retardation prior to the underlying diagnosis which
- •resulted in the alloSCT.
- •Evidence of clinically active tuberculosis (clinical
- •diagnosis per local practice)
- •Any corticosteroid therapy for indications other
- •than cGvHD at doses > 1 mg/kg/day methylprednisolone (or equivalent prednisone dose 1.25 mg/kg/day) within 7 days of the screening visit.
- •History of progressive multifocal leukoencephalopathy (PML).
- •Presence of severely impaired renal function
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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