Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT07185503
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009091', 'term': 'Mucormycosis'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D020096', 'term': 'Zygomycosis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C068538', 'term': 'liposomal amphotericin B'}, {'id': 'C101425', 'term': 'posaconazole'}, {'id': 'C508735', 'term': 'isavuconazole'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Association Between Baseline/Treatment Features and Survival Outcomes', 'timeFrame': 'Data analyzed post-study completion, using baseline and longitudinal data collected throughout the trial (6-18 months post-enrollment).', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Composite Response Rate at End of liposomal amphotericin B (L-AmB) (3-5 mg/kg/day IV) Therapy', 'timeFrame': 'Assessed immediately after discontinuation of liposomal amphotericin B therapy.', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Survival Rate at Key Time Points', 'timeFrame': 'Day 84', 'description': '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.'}, {'measure': 'Time to Favorable Overall Response', 'timeFrame': 'From date of enrollment until the date of first documented response, assessed up to 84 dsys.', 'description': 'Duration from study enrollment to achievement of a favorable overall response (complete or partial resolution of mucormycosis symptoms, radiological improvement, and microbiological clearance).'}, {'measure': 'Length of Hospitalization', 'timeFrame': 'Measured immediately after the intervention', 'description': 'Total number of days participants spend hospitalized from enrollment until discharge or death.'}, {'measure': 'Safety and Tolerability Profile', 'timeFrame': 'Measured immediately after the intervention', 'description': 'Incidence and severity of treatment-emergent adverse events (TEAEs), including nephrotoxicity, hepatotoxicity, infusion reactions, and electrolyte abnormalities, graded per CTCAE v5.0 criteria.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mucormycosis', 'Hematologic Malignancies', 'Liposomal Amphotericin B', 'posaconazole or isavuconazole'], 'conditions': ['Mucormycosis in Hematologic Malignancies']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mucormycosis in Hematologic Malignancies patients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of a hematologic malignancy (e.g., leukemia, lymphoma, myelodysplastic syndrome).\n* Proven, probable, or possible invasive mucormycosis according to the 2019 European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria.\n* Age ≥18 years and ≤65 years at enrollment.\n* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.\n* No clinically significant organ dysfunction (e.g., renal, hepatic, cardiac) at screening that would preclude protocol-defined therapies.\n* Ability to understand the study procedures and provide voluntary written informed consent.\n\nExclusion Criteria:\n\n* Prior treatment with non-liposomal amphotericin B formulations (e.g., amphotericin B deoxycholate) for ≥4 days.\n* Documented hypersensitivity, severe immediate allergic reaction, or intolerance to liposomal amphotericin B.\n* History of a second malignancy (other than the index hematologic malignancy) treated within the past 3 years.\n* Active HIV infection, hepatitis B virus (HBV) infection (HBsAg-positive), hepatitis C virus (HCV) infection (RNA-positive), or syphilis.\n* Psychiatric disorders, cognitive impairment, or other conditions impairing compliance with study procedures or assessments.\n* Pregnant females, breastfeeding females, or individuals of reproductive potential unwilling to use effective contraception during treatment and for ≥3 months post-therapy.\n* Serum creatinine ≥2.0 × upper limit of normal (ULN).\n* Liver transaminases (ALT/AST) or alkaline phosphatase ≥5.0 × ULN.\n* Total bilirubin ≥3.0 × ULN (isolated bilirubin ≥3.0 × ULN is permitted if due to Gilbert's syndrome or hemolysis).\n* Patients deemed ineligible by the investigator due to medical, ethical, or logistical reasons."}, 'identificationModule': {'nctId': 'NCT07185503', 'briefTitle': 'Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'QTJC2025004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single-arm,multi-center real-world study', 'description': 'This is a single-arm study where all participants receive the same treatment. Participants will be treated with a combination antifungal regimen comprising:\n\n1. Liposomal Amphotericin B (L-AmB):\n\n Dose: 3-5 mg/kg/day administered intravenously (IV). Duration: Daily infusions until clinical stability, with adjustments permitted based on disease severity and tolerability.\n2. Posaconazole or Isavuconazole:\n\nFormulations: 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.', 'interventionNames': ['Drug: liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole']}], 'interventions': [{'name': 'liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Single-arm,multi-center real-world study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dalian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinsong Yan', 'role': 'CONTACT', 'email': 'yanjsdmu@dmu.edu.cn', 'phone': '+86155 4117 8715'}], 'facility': 'The Second Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Harbin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengjin Fan', 'role': 'CONTACT', 'email': 'fansjhmu@163.com', 'phone': '+8613304641978'}], 'facility': 'The First Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Shenyang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aijun Liao', 'role': 'CONTACT', 'email': 'liaoaijun@sina.com', 'phone': '+8618940259833'}], 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojing Yan', 'role': 'CONTACT', 'email': 'yanxiaojing_pp@hotmail.com', 'phone': '+8613889128302'}], 'facility': 'The First Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '300020', 'city': 'Tianjin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingfeng Zhao', 'role': 'CONTACT', 'email': 'mingfengzhao@sina.com', 'phone': '+8613752640369'}], 'facility': 'Tianjin First Central Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sizhou Feng', 'role': 'CONTACT', 'email': 'szfeng@ihcams.ac.cn'}], 'facility': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Bai', 'role': 'CONTACT', 'email': 'janebai86@tmu.edu.cn', 'phone': '+86189 0206 6758'}], 'facility': 'Second Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Naibo Hu', 'role': 'CONTACT', 'phone': '+86139 2017 8129'}], 'facility': 'Tianjin Haihe Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Tianjin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingli Zhao', 'role': 'CONTACT', 'email': 'insectzhao@163.com', 'phone': '+86137 5225 5454'}], 'facility': 'Tianjin Union Medical Center of Nankai University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Sizhou Feng, professor', 'role': 'CONTACT', 'email': 'szfeng@ihcams.ac.cn', 'phone': '+8618322098556'}], 'overallOfficials': [{'name': 'Sizhou Feng', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}