Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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 ri

Первичные конечные точки

• Composite Response Rate at End of liposomal amphotericin B (L-AmB) (3-5 mg/kg/day IV) Therapy [Срок оценки: Assessed immediately after discontinuation of liposomal amphotericin B therapy.]

Вторичные конечные точки (4)

• Survival Rate at Key Time Points [Срок оценки: Day 84]
• Time to Favorable Overall Response [Срок оценки: From date of enrollment until the date of first documented response, assessed up to 84 dsys.]
• Length of Hospitalization [Срок оценки: Measured immediately after the intervention]
• Safety and Tolerability Profile [Срок оценки: Measured immediately after the intervention]

Критерии участия

Критерии включения

• Confirmed diagnosis of a hematologic malignancy (e.g., leukemia, lymphoma, myelodysplastic syndrome).
• Proven, probable, or possible invasive mucormycosis according to the 2019 European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria.
• Age ≥18 years and ≤65 years at enrollment.
• Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
• No clinically significant organ dysfunction (e.g., renal, hepatic, cardiac) at screening that would preclude protocol-defined therapies.
• Ability to understand the study procedures and provide voluntary written informed consent.

Критерии исключения

• Prior treatment with non-liposomal amphotericin B formulations (e.g., amphotericin B deoxycholate) for ≥4 days.
• Documented hypersensitivity, severe immediate allergic reaction, or intolerance to liposomal amphotericin B.
• History of a second malignancy (other than the index hematologic malignancy) treated within the past 3 years.
• Active HIV infection, hepatitis B virus (HBV) infection (HBsAg-positive), hepatitis C virus (HCV) infection (RNA-positive), or syphilis.
• Psychiatric disorders, cognitive impairment, or other conditions impairing compliance with study procedures or assessments.
• Pregnant females, breastfeeding females, or individuals of reproductive potential unwilling to use effective contraception during treatment and for ≥3 months post-therapy.
• Serum creatinine ≥2.0 × upper limit of normal (ULN).
• Liver transaminases (ALT/AST) or alkaline phosphatase ≥5.0 × ULN.
• Total bilirubin ≥3.0 × ULN (isolated bilirubin ≥3.0 × ULN is permitted if due to Gilbert's syndrome or hemolysis).
• Patients deemed ineligible by the investigator due to medical, ethical, or logistical reasons.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 9 центров

• The Second Hospital of Dalian Medical University — Dalian
• The First Affiliated Hospital of Harbin Medical University — Харбин
• Shengjing Hospital of China Medical University — Шэньян
• The First Affiliated Hospital of China Medical University — Шэньян
• Tianjin First Central Hospital — Тяньцзинь
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & P — Тяньцзинь
• Second Hospital of Tianjin Medical University — Тяньцзинь
• Tianjin Haihe Hospital — Тяньцзинь
• … и ещё 1 центр

Идентификаторы

NCT: NCT07185503 · QTJC2025004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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