EURO-HIT-HLH European cooperative pilot study for testing Hybrid ImmunoTherapy for Hemophagocytic LymphoHistiocytosis

EURO-HIT-HLH European cooperative pilot study for testing Hybrid ImmunoTherapy for Hemophagocytic LymphoHistiocytosis - EURO-HIT-HLH

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002052-14-IT

Enrollment

Registered

2012-01-19

Start date

2011-06-07

Completion date

Unknown

Last updated

2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial hemophagoytic lymphohistiocytosis MedDRA version: 14.1 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Trade Name: THYMOGLOBULINE*1F 25MG 10ML Pharmaceutical Form: Concentrate for solution for injection Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 25- Trade Name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis: The diagnosis of hemophagocytic lymphohistiocytosis must be met according to the HLH-2004 criteria. Age: Patients =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Recent treatment, within 3 months, with another therapeutic regimen for HLH. -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

Design outcomes

Primary

Measure	Time frame
Main Objective: To achieve an early disease control thus allowing the patient to undergo HSCT when appropriate, in the shortest time. Primary endopoint: survival at 8 weeks;Secondary Objective: - Response to therapy at 2, 4 and 8 weeks - Reactivation during and after initial treatment - proportion of patients who may undergo HSCT;Primary end point(s): Primary endopoint: survival at 8 weeks;Timepoint(s) of evaluation of this end point: Eight weeks from treatment start	—

Measure

Time frame

Main Objective: To achieve an early disease control thus allowing the patient to undergo HSCT when appropriate, in the shortest time. Primary endopoint: survival at 8 weeks;Secondary Objective: - Response to therapy at 2, 4 and 8 weeks - Reactivation during and after initial treatment - proportion of patients who may undergo HSCT;Primary end point(s): Primary endopoint: survival at 8 weeks;Timepoint(s) of evaluation of this end point: Eight weeks from treatment start

—

Secondary

Measure	Time frame
Secondary end point(s): - Response to therapy at 2, 4 and 8 weeks - Reactivation during and after initial treatment - proportion of patients who may undergo HSCT;Timepoint(s) of evaluation of this end point: All within day 100 from treatment start.	—

Countries

Austria, Germany, Italy

Contacts

Public ContactOncoematologia Pediatrica

AOU MEYER

m.arico@meyer.it0555662739

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026