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Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
This clinical trial, a single-arm prospective study, aims to evaluate the efficacy and safety of liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole in treating adult patients with malignant hematological diseases complicated by mucormycosis. The primary objectives are to determine the proportion of patients achieving complete or partial resolution of mucormycosis symptoms and to identify prognostic factors influencing survival outcomes. Participants will receive the combination therapy, undergo regular monitoring of symptoms, adverse events, and disease progression via radiological and laboratory assessments, and complete follow-up visits to track long-term survival. The study will analyze composite response rates, treatment-related adverse events, and survival data to refine therapeutic strategies for this high-risk population.
Official title: The Efficacy and Safety of Liposomal Amphotericin B 3-5mg/kg Combined With Posaconazole/Isavuconazole for the Treatment of Mucormycosis in Patients With Hematologic Malignancies
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2025-03-25
Completion Date
2027-01
Last Updated
2025-09-22
Healthy Volunteers
No
Conditions
Interventions
liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole
The intervention in this study is a tailored antifungal regimen combining liposomal amphotericin B (L-AmB) (3-5 mg/kg/day IV) with posaconazole or isavuconazole (300 mg/200 mg daily, oral or IV), designed to optimize efficacy and safety in immunocompromised adults with blood cancers and mucormycosis. Dosing and duration are personalized based on clinical response, immune recovery, and organ function, with a focus on transitioning to oral therapy to reduce hospitalization. The study emphasizes rigorous safety monitoring, prohibited unauthorized antifungal co-medications, and explores prognostic factors to advance treatment strategies for this high-risk population.
Locations (9)
The Second Hospital of Dalian Medical University
Dalian, China
The First Affiliated Hospital of Harbin Medical University
Harbin, China
Shengjing Hospital of China Medical University
Shenyang, China
The First Affiliated Hospital of China Medical University
Shenyang, China
Tianjin First Central Hospital
Tianjin, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China
Second Hospital of Tianjin Medical University
Tianjin, China
Tianjin Haihe Hospital
Tianjin, China
Tianjin Union Medical Center of Nankai University
Tianjin, China