Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia
NCT ID: NCT03187691
Last Updated: 2019-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2019-08-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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CAMB 200 mg
200 mg CAMB (MAT2203) Oral Amphotericin B
Oral Encochleated Amphotericin B (CAMB)
Lipid-crystal nano-particle formulation amphotericin B
CAMB 400 mg
400 mg CAMB (MAT2203) Oral Amphotericin B
Oral Encochleated Amphotericin B (CAMB)
Lipid-crystal nano-particle formulation amphotericin B
CAMB 800mg
800 mg CAMB (MAT2203) Oral Amphotericin B
Oral Encochleated Amphotericin B (CAMB)
Lipid-crystal nano-particle formulation amphotericin B
Interventions
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Oral Encochleated Amphotericin B (CAMB)
Lipid-crystal nano-particle formulation amphotericin B
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to have all screening tests done to allow for study drug administration no later than 5 days after start of chemotherapy
* Sign informed consent
* ≥ 18 years of age
Exclusion Criteria
* Fungal induced fever (≥ 38°C)
* Proven, possible or probably invasive fungal infection in previous 12 months
* Serum galactomannan index (GMI)≥ 0.5 at screening
* Pulmonary infiltrates at screening
* Current treatment with amphotericin B
* Sever comorbidity other than underlying haematological disease
* Prolongation of corrected QT interval
* History of convulsion
* Pregnant or breastfeeding
* Females of childbearing potential who do not practice sexual abstinence or who do not agree to use appropriate contraceptive methods
* Presence of hepatic disease
* Total bilirubin \> 3 x upper limit of normal
* Age-adjusted creatinine clearance \< 30 mL/minute
* Participating in any other clinical study
18 Years
ALL
No
Sponsors
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University of Cologne
OTHER
The Clinical Trials Centre Cologne
OTHER
Matinas BioPharma Nanotechnologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Oliver Cornely, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cologne
Other Identifiers
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MB-70006
Identifier Type: -
Identifier Source: org_study_id
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