Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419770
Status:
COMPLETED
Last Update Posted:
2023-10-16
First Post:
2007-01-05
Brief Title:
The Deferasirox-AmBisome Therapy for Mucormycosis DEFEAT Mucor Study
Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Organization:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Overview
Official Title:
The Deferasirox-AmBisome Therapy for Mucormycosis DEFEAT Mucor Study
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 EORTCMSG 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
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 EORTCMSG 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None