CTIS2024-513173-44-00进行中（未招募）1 期
HLH-JAK - Treatment of non severe Hemophagocytosis Lymphohistiocytosis with ITACITINIB a Phase II prospective trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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)
研究者
相似试验
进行中（未招募）
1 期
JAKAHDI - JAK inhibitors in acquired hemophagocytic syndrome in the ICCTIS2023-504513-77-00Assistance Publique Hopitaux De Paris42
尚未招募
2 期
JAK Inhibitor in Acquired Hemophagocytic synDrome in the Intensive Care UnitHemophagocytic SyndromesNCT06244862Assistance Publique - Hôpitaux de Paris42
招募中
2 期
Treatment of non severe Hemophagocytosis Lymphohistiocytosis with ITACITINIB a Phase II prospective trial2024-513173-44-00Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris70
已完成
2 期
Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIBAdults Patients Having Non Severe HLHNCT05063110Assistance Publique - Hôpitaux de Paris35
进行中（未招募）
1 期
JeRiCHO: A study to improve the treatment of relapsed or refractory Hodgkin Lymphoma with JAK-inhibitor (Ruxolitinib).relapsed or refractoryHodgkin LymphomaEUCTR2013-003369-33-DEniversity of cologne14