NCT07559032

Brief Summary

The goal of this clinical trial is to learn if amphotericin B works to treat breakthrough invasive fungal disease (IFD) in patients with hematological diseases who have received azole-based prophylaxis. It will also learn about the safety of amphotericin B in this population. The main questions it aims to answer are:

  1. 1.What is the overall response rate (complete remission + partial remission) of amphotericin B in treating breakthrough IFD after azole prophylaxis?
  2. 2.What medical problems do participants have when taking amphotericin B?
  3. 3.What is the 6-week (42-day) overall survival rate after starting treatment?
  4. 4.Receive intravenous liposomal amphotericin B (3-5 mg/kg daily) for 4-6 weeks.
  5. 5.Undergo weekly clinical and laboratory assessments, including serum G/GM tests, microbiology tests, and imaging (CT) at 2, 4, and 6 weeks.
  6. 6.Have safety monitoring including liver and kidney function, electrolytes, and ECG.
  7. 7.Be followed for treatment response and survival.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
33mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Dec 2028

Study Start

First participant enrolled

April 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

April 12, 2026

Last Update Submit

April 26, 2026

Conditions

Invasive Fungal Disease

Keywords

Breakthrough fungal infectionInvasive fungal diseaseTriazole prophylaxisAmphotericin BHematological diseases

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate of Antifungal Therapy at 6 Weeks (42 Days)

    The overall response rate will be assessed at 6 weeks (42 days) after the initiation of amphotericin B treatment, evaluated according to the EORTC/MSG 2020 criteria for invasive fungal disease, including complete response, partial response, stable disease, and progressive disease.

    6 weeks (42 days) after treatment initiation

Secondary Outcomes (13)

  • Overall Survival Rate at 6 Weeks

    6 weeks (42 days) after treatment initiation

  • Change in serum G test level

    From enrollment to the end of 6-week treatment

  • Change in serum GM test level

    From enrollment to the end of 6-week treatment

  • Microbiological clearance

    From enrollment to the end of 6-week treatment

  • Change in chest CT findings

    Baseline to 6 weeks after treatment initiation

  • +8 more secondary outcomes

Study Arms (1)

Amphotericin B Treatment

EXPERIMENTAL
Drug: Amphotericin B

Interventions

Amphotericin BDRUG

Amphotericin B is a polyene antifungal drug used to treat breakthrough fungal infections. The dosage and duration will be determined based on pathogen results and clinical guidelines.

Amphotericin B Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old.
  • Diagnosed with hematological diseases and receiving triazole prophylaxis.
  • Confirmed or suspected breakthrough invasive fungal disease (IFD) according to EORTC/MSG 2020 criteria.
  • Able to understand and sign the informed consent form voluntarily.

You may not qualify if:

  • Severe liver or renal dysfunction (ALT/AST \> 3×ULN, Cr \> 2×ULN).
  • Known allergy to amphotericin B or any component of the study drug.
  • Pregnant or lactating women.
  • Severe underlying diseases with expected survival \< 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Invasive Fungal InfectionsHematologic Diseases

Interventions

Amphotericin B

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Central Study Contacts

Rui Ma

CONTACT

+86 18834948122marui_pku_ed@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2026

First Posted

April 30, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)