2024-513173-44-00招募中2 期
HLH-JAK - Treatment of non severe Hemophagocytosis Lymphohistiocytosis with ITACITINIB a Phase II prospective trial
Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris15 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月29日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 15
- 主要终点
- Overall response rate (RR) achievement of either a Complete (CR) or a Partial response (PR) at day 15 of ITACITINIB treatment on clinical and biological symptoms of primitive/refractory/relapses in non-severe adults HLHs
研究概览
简要总结
Overall response rate (RR) defined as achieving a Complete (CR) or a Partial response (PR) at day 15 of ITACITINIB treatment on clinical and biological symptoms of primitive/refractory/relapses in non-severe adults HLHs
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients age >= 18 years, with front line or recurrent sporadic HLH, without or awaiting diagnosis of associated pathologies that may benefit from specific treatment, without severity criteria, without organ failure
- •Major criteria: (i) Cytological features of hemophagocytosis (ii) Fever (iii) Splenomegaly
- •Minor criteria: (i) Adenopathies (ii) Cytopenia> 2 lineages: - Haemoglobin < 9 g/dl, - Platelets < 100 000/mm3 - Neutrophils < 1000/mm3 (iii) Hypertriglyceridemia > 3 mmol/l and/or hypofibrigenemia < 1.5 g/l (iv) Ferritin>500 μg/l
- •HScore ≥ 169
- •Patient is willing to provide written informed consent prior to enrolment and agrees to follow the protocol
- •Patient known to have systemic juvenile idiopathic arthritis are classified as having HLH if they met the following criteria: (i) Ferritin > 684 ng/mL and (ii) any 2 of the following: - Platelet count < 181 000/mm3, - ASAT > 48 UI/ml, - Triglyceride > 4 mmol/L, - Fibrinogen < 3.6 g/L
- •Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the duration of the study
- •Be either affiliated to, or a beneficiary of, a social security category
排除标准
- •Organ failure (at least one of those criteria): - Confusion, glasgow < 13, - Organic kidney failure requiring dialysis or KDIGO > 2, - Liver failure (Factor V < 50%), - Heart failure requiring catecholamines, - Respiratory failure requiring assisted ventilation
- •HIV infection with positive viral charge (note: in case of negative HIV antibody, it is not necessary to perform the PCR HIV RNA)Protected adults (including individual under guardianship by court order)
- •Vulnerable adults, under a safeguard of justice measure
- •Adults deprived of their liberty by judicial or administrative decision
- •Persons under psychiatric care without their consent
- •Persons admitted to social institution for purposes other this research
- •Adults under legal protection (guardianship or curatorship)
- •Persons unable to express their consent
- •Fibrinogen < 0.50 g/l, platelets <20G/L
- •Patient participating in another investigational therapeutic study
- •Breastfeeding women
- •Women with a positive pregnancy test or not willing to take contraceptive measures
- •Known allergies, hypersensitivity, or intolerance to any of the ITACITINIB or excipients, or similar compounds
- •Current or history of recurrent infections, including HBV, HCV
- •Participants with active HBV infection that requires treatment or who are at risk for HBV reactivation (ie Positive HBs Ag serology)
- •Candidates positive for HCV antibody and positive PCR RNA HCV (note: in case of negative result of HCV antibody, it is not necessary to perform the PCR HCV RNA)
结局指标
主要结局
Overall response rate (RR) achievement of either a Complete (CR) or a Partial response (PR) at day 15 of ITACITINIB treatment on clinical and biological symptoms of primitive/refractory/relapses in non-severe adults HLHs
Overall response rate (RR) achievement of either a Complete (CR) or a Partial response (PR) at day 15 of ITACITINIB treatment on clinical and biological symptoms of primitive/refractory/relapses in non-severe adults HLHs
次要结局
未报告次要终点
研究者
Coordinating Investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (15)
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