Treatment protocol of the second international study for hemophagoocytic lymphohistiocytosis (HLH) - HLH-2004

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002391-17-IT

Enrollment

400

Registered

2012-03-05

Start date

2005-03-10

Completion date

Unknown

Last updated

2014-01-27

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

Conditions

Hemophagocytic lymphohistiocytosis (HLH) MedDRA version: 14.1 Level: PT Classification code 10049646 Term: Lymphohistiocytosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Etoposide CAS Number: 33419-42-0 Concentration unit: mg milligram(s) Concentration number: 100- Pharmaceutical F

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: International criteria: fever, splenomegaly, cytopenia, hypertriglyceridemia, hypofibrinogenemia, defective NK activity Are the trial subjects under 18? yes Number of subjects for this age range: 0 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

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main Objective: To improve the survival of children with HLH;Secondary Objective: Define the genetic diagnosis of patients with HLH;Primary end point(s): Survival at 2 months and 5 years	—

Countries

Italy

Outcome results

None listed

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