European cooperative study for testingTherapy for Hemophagocytic LymphoHistiocytosis

Phase 1

• Conditions: Hemophagocytic lymphohistiocytosis; MedDRA version: 15.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-002052-14-DE
• Lead Sponsor: AZIENDA OSPEDALIERA MEYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-07
• Last Update Posted: 21 July 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified