RecruitingPhase 2

Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy

United States60 participantsStarted 2026-02-13

Plain-language summary

The purpose of this study is to determine if EL219 is safe and effective compared to liposomal amphotericin B (LAmB) or voricanozole for early treatment of invasive mould infections

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Willing and able to provide written informed consent.
✓. 18 years and older, of any gender, race, or ethnicity
✓. Are at risk for invasive fungal infections (IFIs), by virtue of acquired or inherited immunocompromising condition including but not limited to the following:
✓. Receipt of a blood or marrow transplant (BMT) from an allogeneic donor
✓. Active hematologic malignancy.
✓. Recent neutropenia with absolute neutrophil count \<500 cells/mm3 \>10 days
✓. Receipt of corticosteroids at mean minimum doses of 0.3 mg/kg/day prednisone equivalent for \>3 weeks.
✓. Receipt of other recognized T-cell immunosuppressants, such as cyclosporin, tumor necrosis factor alpha (TNF-α) blockers, or specific monoclonal antibodies during the last 3 months.

Exclusion criteria

✕. Participant has received prior antifungal treatment (azole or echinocandin prophylaxis permitted) for \>96 hours prior to randomization.
✕. Active, microbiologically confirmed systemic bacterial infection with ongoing receipt of antibacterial therapy. Antibacterial prophylaxis and secondary therapy is allowed, providing that follow-up cultures have been without growth for \>2 days.
✕. Participants with 1 or more of the following laboratory abnormalities as defined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v5.0:
✕. Alanine aminotransferase (ALT) ≥5 × upper limit of normal (ULN).
✕. Total serum bilirubin ≥5 × ULN (excluding Gilbert's Syndrome).
✕. Serum creatinine ≥2 mg/dL or creatinine clearance (CrCL) ≤30 mL/minute.
✕. Known cirrhosis of the liver, diagnosed according to country or Medical Society-specific guidelines and documented in the medical records prior to screening.
✕. Known New York Heart Association (NYHA) Class III or Class IV heart failure.

What they're measuring

Primary Outcome/Measure All-Cause Mortality

Timeframe: From enrollment to Day 21

Primary Outcome/Measure SAE TEAE

Timeframe: From enrollment to the end of treatment at Day 42

Trial details

NCT IDNCT07215273

SponsorElion Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Laura A. Navalta

443-423-1785 info@eliontx.com

View on ClinicalTrials.gov More Invasive Mould Infection trials