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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
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.
This research aims to test whether combining two antifungal medications-liposomal amphotericin B (given through an IV) and either posaconazole or isavuconazole (available as IV or oral pills)-can effectively and safely treat adults with blood cancers (like leukemia or lymphoma) who develop a severe fungal infection called mucormycosis. Current guidelines often recommend amphotericin B-based therapies, but optimal dosing, combinations, and treatment duration remain unclear. This study will provide critical data on whether a regimen of liposomal amphotericin B (3-5 mg/kg/day) paired with newer antifungals (posaconazole/isavuconazole) can enhance outcomes. It will also identify which patient characteristics (e.g., age, cancer type, recovery speed) most strongly affect survival, helping doctors personalize care.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
March 25, 2025
Primary Completion Date
June 1, 2026
Completion Date
January 1, 2027
Last Updated
September 22, 2025
60
ESTIMATED participants
liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole
DRUG
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Data Source & Attribution
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