Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT07185503
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07185503
Study Brief:
Protocol Section:
NCT07185503