Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety
报名条件（概要）
- 年龄：18 Years – 65 Years
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
药品与企业信息
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.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
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.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
- Sizhou Feng, professorszfeng@ihcams.ac.cn+8618322098556
中国／港澳台研究中心
- The Second Hospital of Dalian Medical UniversityDalian，China
- The First Affiliated Hospital of Harbin Medical UniversityHarbin，China
- Shengjing Hospital of China Medical UniversityShenyang，China
- The First Affiliated Hospital of China Medical UniversityShenyang，China
- Tianjin First Central HospitalTianjin，China
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeTianjin，China
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety ClinicalTrials.gov Identifier: NCT07185503 Sponsor: Institute of Hematology & Blood Diseases Hospital, China Investigational product: liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety 试验编号：NCT07185503 申办方：Institute of Hematology & Blood Diseases Hospital, China 研究药物：liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。