European cooperative pilot study for testingHybrid ImmunoTherapy forHemophagocytic LymphoHistiocytosis - EURO-HIT-HLH

AZIENDA OSPEDALIERA MEYER0 个研究点目标入组 60 人开始时间: 2014年1月8日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•Diagnosis: The diagnosis of hemophagocytic lymphohistiocytosis must be met according to the HLH-2004 criteria.
•Patients <18 years of age.
•Disease Status: The patient must have active disease at the time of enrollment. If the diagnosis is made by genetic criteria, the patient must also meet at least 4 out of 8 clinical criteria. Clinical and/or laboratory observations establishing the diagnosis of active HLH (except NK function) must occur no more than 1 week prior to study entry.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Recent treatment, within 3 months, with another therapeutic regimen for HLH, such as HLH-2004 would make patients ineligible. Pretreatment with ATG or CAMPATH at any time would make patients ineligible. Pretreatment with corticosteroids for up to 7 days at any dose is acceptable. Treatment for up to 14 days is acceptable if corticosteroid doses are less than the equivalent of 1mg/kg/day of methylprednisone. Patients may receive up to1 dose of intrathecal methotrexate/prednisolone prior to study entry.
•Known active malignancy
•Known rheumatologic diagnosis which may be the underlying cause of HLH, such as systemic onset juvenile idiopathic arthritis or systemic lupus erythematosus
•Pregnancy (as determined by serum or urine test) or active breast feeding
•Failure to provide signed informed consent

发起方

AZIENDA OSPEDALIERA MEYER