MedTrace Logo

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

NCT07185503 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Mucormycosis in Hematologic Malignancies

Interventions

DRUG

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 rigorous safety monitoring, prohibited unauthorized antifungal co-medications, and explores prognostic factors to advance treatment strategies for this high-risk population.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Sizhou Feng · Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2026-06-30
Completion
2027-01-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07185503 on ClinicalTrials.gov