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A Phase 2/3, Open-label, Single-arm, Multicenter, Historical Control Study to Evaluate ELA026 in Participants with Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520624-25-00
Acronym
ELA026-CP002
Enrollment
40
Registered
2025-08-05
Start date
2025-09-19
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Brief summary

56-day survival from the time of diagnosis

Detailed description

30-day, 45-day, 56-day (any type of cancer), 90-day survival (early survival) from time of diagnosis; Survival status at hospital discharge for initial hospital admission for sHLH; Number of participants achieving HLH disease response by Day 29 (modified HLH-2004 criteria and biomarker criteria)., HLH disease response is defined as a participant who achieves complete response, modified CR, partial response, or HLH improvement; Incidence of treatment-emergent adverse events

Interventions

DRUGELA026

Sponsors

Electra Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
56-day survival from the time of diagnosis

Secondary

MeasureTime frame
30-day, 45-day, 56-day (any type of cancer), 90-day survival (early survival) from time of diagnosis; Survival status at hospital discharge for initial hospital admission for sHLH; Number of participants achieving HLH disease response by Day 29 (modified HLH-2004 criteria and biomarker criteria)., HLH disease response is defined as a participant who achieves complete response, modified CR, partial response, or HLH improvement; Incidence of treatment-emergent adverse events

Countries

Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026