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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm,multi-center real-world study | This is a single-arm study where all participants receive the same treatment. Participants will be treated with a combination antifungal regimen comprising:
Formulations: Oral tablets or intravenous (IV) formulations. Dosing: Loading dose: As per product labeling. Maintenance dose: 300 mg (posaconazole) or 200 mg (isavuconazole) once daily. Duration: Continued orally after discontinuation of L-AmB, per clinical judgment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite 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). | Assessed immediately after discontinuation of liposomal amphotericin B therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 84 |
| Time to Favorable Overall Response |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Baseline/Treatment Features and Survival Outcomes | Exploratory analysis to evaluate correlations between pre-treatment (e.g., neutrophil count, cancer stage, comorbidities), intra-treatment (e.g., time to clinical stability, antifungal dose adjustments), and radiological features (e.g., lesion size, anatomical location) with overall survival and disease relapse. Statistical methods (e.g., Cox regression, machine learning) will identify potential prognostic biomarkers or clinical predictors. |
Inclusion Criteria:
Exclusion Criteria:
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Mucormycosis in Hematologic Malignancies patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sizhou Feng, professor | Contact | +8618322098556 | szfeng@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Sizhou Feng | Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Dalian Medical University | Not yet recruiting | Dalian | China |
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Duration from study enrollment to achievement of a favorable overall response (complete or partial resolution of mucormycosis symptoms, radiological improvement, and microbiological clearance). |
| 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. | 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. | Measured immediately after the intervention |
| Data analyzed post-study completion, using baseline and longitudinal data collected throughout the trial (6-18 months post-enrollment). |
| The First Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | China |
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| Shengjing Hospital of China Medical University | Not yet recruiting | Shenyang | China |
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| The First Affiliated Hospital of China Medical University | Not yet recruiting | Shenyang | China |
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| Tianjin First Central Hospital | Not yet recruiting | Tianjin | 300020 | China |
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| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting | Tianjin | China |
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| Second Hospital of Tianjin Medical University | Not yet recruiting | Tianjin | China |
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| Tianjin Haihe Hospital | Not yet recruiting | Tianjin | China |
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| Tianjin Union Medical Center of Nankai University | Not yet recruiting | Tianjin | China |
|
| ID | Term |
|---|---|
| D009091 | Mucormycosis |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D020096 | Zygomycosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C068538 | liposomal amphotericin B |
| C101425 | posaconazole |
| C508735 | isavuconazole |
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