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.
Study Type
OBSERVATIONAL
Enrollment
60
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.
The Second Hospital of Dalian Medical University
Dalian, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Harbin Medical University
Harbin, China
NOT_YET_RECRUITINGShengjing Hospital of China Medical University
Shenyang, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of China Medical University
Shenyang, China
NOT_YET_RECRUITINGTianjin First Central Hospital
Tianjin, China
NOT_YET_RECRUITINGInstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China
RECRUITINGSecond Hospital of Tianjin Medical University
Tianjin, China
NOT_YET_RECRUITINGTianjin Haihe Hospital
Tianjin, China
NOT_YET_RECRUITINGTianjin Union Medical Center of Nankai University
Tianjin, China
NOT_YET_RECRUITINGComposite Response Rate at End of liposomal amphotericin B (L-AmB) (3-5 mg/kg/day IV) Therapy
The proportion of participants achieving a composite response, defined as the complete or partial resolution of mucormycosis-related clinical symptoms, radiological improvement (e.g., reduction in lesion size on CT/MRI), and microbiological clearance (e.g., negative fungal cultures or biomarkers).
Time frame: Assessed immediately after discontinuation of liposomal amphotericin B therapy.
Survival Rate at Key Time Points
Proportion of participants alive at (1) end of liposomal amphotericin B (L-AmB) therapy, (2) 42 days post-therapy, and (3) 84 days post-therapy. Survival is defined as being free from death due to any cause.
Time frame: Day 84
Time to Favorable Overall Response
Duration from study enrollment to achievement of a favorable overall response (complete or partial resolution of mucormycosis symptoms, radiological improvement, and microbiological clearance).
Time frame: From date of enrollment until the date of first documented response, assessed up to 84 dsys.
Length of Hospitalization
Total number of days participants spend hospitalized from enrollment until discharge or death.
Time frame: Measured immediately after the intervention
Safety and Tolerability Profile
Incidence and severity of treatment-emergent adverse events (TEAEs), including nephrotoxicity, hepatotoxicity, infusion reactions, and electrolyte abnormalities, graded per CTCAE v5.0 criteria.
Time frame: Measured immediately after the intervention
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