EUCTR2018-003296-35-LT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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