The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) Study

Completed · Phase 2 · Has a placebo group

Conditions studied: Mucormycosis

In brief

The purpose of this study is to determine if the addition of the medication, deferasirox, to standard antifungal therapy for the infection, mucormycosis, is safe and effective

Key facts

Study ID

NCT00419770

Run by

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

People needed

20

Starts

2007-10-01

Expected to finish

2010-12-01

Last updated by the study team

2023-10-16

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 2 years.
• Proven or probable invasive mucormycosis, as defined by modification of consensus European Organization for Research and Treatment of Cancer (EORTC)/Mycosis Study Group (MSG) criteria. In brief, proven mucormycosis is defined as: 1) histopathologic or cytopathologic examination showing broad-based, aseptate, ribbon-like hyphae consistent with Mucorales from needle aspiration or biopsy specimen, with evidence of associated tissue damage (either microscopically or unequivocally by imaging); OR 2) a positive culture result for a sample obtained by sterile procedure from normally sterile and clinically or radiologically abnormal site consistent with infection, excluding urine and mucous membranes. Probable mucormycosis is defined as: 1) an at-risk host; AND 2) positive culture, cytology, or polymerase chain reaction (PCR) test (run at a CLIA-certified clinical microbiology laboratory) from sputum, bronchoalveolar lavage (BAL), endoscopy/colonoscopy, or sinus aspirate/biopsy; AND 3) 1 major or 2 minor clinical criteria.
• Radiographic study by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) has been obtained within 4 calendar days prior to enrollment and shows evidence of infection (i.e. focal nodule, mass, or abscess, or enhancement, or evidence of tissue edema or destruction that is not attributed to post-surgical reaction).
• Subject or authorized decision maker able to provide informed consent.

You may not qualify if…

• High likelihood of death within the 48 h after enrollment (investigator's discretion).
• High likelihood of death due to factors unrelated to mucormycosis (e.g. due to uncontrolled and/or relapsed malignancy, severe graft versus host disease, other underlying diseases, etc.) within 30 days following enrollment (investigator's discretion).
• Patient unable to receive enteral medication (oral or via feeding tube).
• Infection limited to the supra-fascial skin (skin lesions in the presence of disseminated disease, deep invasive tissue infection spreading from a primary skin site, or subcutaneous infections extending to fascia are allowed).
• Patient has received > 14 days of polyene antifungal therapy (i.e. amphotericin B deoxycholate, liposomal amphotericin B, amphotericin B lipid complex, or amphotericin B colloidal dispersion) at the time of screening.
• Patient is already taking deferasirox therapy for any reason at the time of screening.
• Patient is allergic to or intolerant of deferasirox or LAmB.
• Patient has significant renal dysfunction at the time of screening, defined as serum creatinine of > 3 mg/dL or a calculated creatinine clearance of < 30 ml/min (by the Cockroft-Gault formula: (140 - age (yrs) * wt (kg)) * 0.85 (for females) / (72 * serum creatinine (mg/dL)).
• Patient has significant hepatic dysfunction at the time of screening, defined as BOTH an AST or ALT > 10 times the upper limit of normal, AND a direct (not total) bilirubin > 5 times the upper limit of normal.
• Women of child-bearing potential (those with menses within the last year) with a positive serum pregnancy test.
• Enrollment refused by the primary physician.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• UCSF — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• Duke University — Durham, North Carolina, United States
• Summa Health Systems — Akron, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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