Multi-center Phase 2 clinical trial for EB virus associated hemophagocytic lymphohistiocytosis of pediatric and adolescent and young adult

Multi-center Phase 2 clinical trial for EB virus associated hemophagocytic lymphohistiocytosis of pediatric and adolescent and young adult - EBV-HLH-15

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041190053

Enrollment

Registered

2019-07-10

Start date

2019-07-22

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

EB virus associated hemophagocytic lymphohistiocytosis 1.EB virus, 2.Hemophagocytic lymphohistiocytosis

Interventions

Based on steroid responsiveness, age and EBV DNA load 2 weeks after the start of the study treatment, the treatment was stratified into low risk (LR), intermediate risk (IR) and high risk (HR) groups,

1. Steroid responce, 2. Age, 3. Copy number of EB virus DNA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Newly diagnosed and untreated patients under 18 years old with EB virus associated hemophagocytic lymphohistiocytosis

Exclusion criteria

Exclusion criteria: 1. < EBV-DNA 1000 copies/microgramDNA 2. Familial hemophagocytic lymphohistiocytosis or X linked lymphoproliferative syndrome 3. EBV HLH due to EB virus reactivation 4 .Coexistence of active cancer 5 .Uncontrolled organ dysfunction

Design outcomes

Primary

Measure	Time frame
1 year event free survival of patients treated with VP-16 (Intermediate risk or high risk patients)	—

Secondary

Measure	Time frame
1. 1 year event free survival by risk group (low risk, intermediate risk, or high risk) 2. 1 year event overall survival by risk group 3. Complete remission rate by risk group 4. Incidence of adverse event (therapy-rerated severe toxicity) by risk group	—

Contacts

Public ContactKenichi Sakamoto

Shinshu University Hospital

sakamoto-k@shinshu-u.ac.jp+81-263-35-4600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026