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Sponsors and Collaborators: |
Los Angeles Biomedical Research Institute Gilead Sciences Astellas Pharma Inc Novartis |
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Information provided by: | Los Angeles Biomedical Research Institute |
ClinicalTrials.gov Identifier: | NCT00419770 |
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
Condition | Intervention | Phase |
---|---|---|
Mucormycosis |
Drug: deferasirox |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Deferasirox-AmBisome Therapy for Mucormycosis (DEFEAT Mucor) Study |
Estimated Enrollment: | 20 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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B: Experimental
Deferasirox
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Drug: deferasirox
20 mg/kg enterally per day
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Because of its extremely high morbidity and mortality, it is imperative to look for new antifungal therapies to treat mucormycosis. The agents of mucormycosis are exquisitely sensitive to iron availability, and we and others have demonstrated that iron chelation therapy improves the survival of rodents with mucormycosis. Deferasirox (Exjade) is the first orally bioavailable iron chelator approved for use in the United States (US) by the Food and Drug Administration (FDA), with an indication for treatment of iron overload from chronic transfusions. In clinical studies, deferasirox has been well tolerated and effective in iron-overloaded patients.
Although the safety and efficacy of deferasirox have been extensively evaluated in iron-overloaded patients, there are minimal data in non-iron-overloaded patients or in infected patients. Therefore, the safety and efficacy of deferasirox in patients with mucormycosis is unclear, and confirming safety in the current study, at the currently planned dose, is required to lay the groundwork for a future phase III clinical trial.
This is a prospective, phase II, randomized, double-blinded, placebo-controlled study of liposomal amphotericin B (LAmB; AmBisome) plus deferasirox vs. LAmB plus placebo for mucormycosis infection. Twenty patients with proven or probable mucormycosis (except for isolated skin infection) by consensus EORTC/MSG criteria, who have received less than 14 days of antifungal therapy for mucormycosis, and who have had radiographic imaging by CT or MRI within the past 72 hours that shows evidence of infection, will be randomized to receive LAmB plus deferasirox or placebo (n = 10 per arm), with randomization stratified by study site.
The primary objective is to determine the safety and tolerability of adjunctive deferasirox therapy in patients being treated with LAmB for mucormycosis, and to obtain exploratory data on the efficacy of the iron chelation treatment. The exploratory efficacy endpoint will be the global response rate (composite of clinical and radiographic response) at end of study drug administration, as determined by a blinded adjudication committee.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brad Spellberg, MD | 310-222-5381 | bspellberg@labiomed.org |
United States, California | |
UCSF | Recruiting |
San Francisco, California, United States, 94143 | |
Principal Investigator: Peter Chin-Hong, MD | |
City of Hope National Medical Center | Recruiting |
Duarte, California, United States, 91010 | |
Contact: Mary Ann Clouser 626-256-4673 ext 62340 MClouser@coh.org | |
Principal Investigator: James Ito, MD | |
United States, Florida | |
University of Miami | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Gabriel Blashke 305-585-7624 GBlaschke@med.miami.edu | |
Principal Investigator: Michele Morris, MD | |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Elizabeth Dodds, PharmD dodds002@mc.duke.edu | |
Principal Investigator: John Perfect, MD | |
United States, Ohio | |
Summa Health Systems | Recruiting |
Akron, Ohio, United States, 44304 | |
Contact: Sara-Jane Salstrom 330-375-4293 salstros@summa-health.org | |
Principal Investigator: Hector Bonilla, MD | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Stacie Wright, RN 713-792-2095 slwright@mdanderson.org | |
Principal Investigator: Dimitrios Kontoyiannis, MD | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Judy Schramm, RN 206-667-4872 | |
Principal Investigator: David Fredericks, MD |
Principal Investigator: | Brad Spellberg, MD | Los Angeles Biomedical Research Institute |
Responsible Party: | Los Angeles Biomedical Research Institute ( Brad Spellberg, MD ) |
Study ID Numbers: | 12842 |
Study First Received: | January 5, 2007 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00419770 |
Health Authority: | United States: Institutional Review Board |
zygomycosis Rhizopus iron iron-chelation adjunctive therapy |
Abelcet Amphotericin B Mycoses Deferasirox |
Mucormycosis Liposomal amphotericin B Iron Zygomycosis |
Molecular Mechanisms of Pharmacological Action Iron Chelating Agents Chelating Agents Pharmacologic Actions |