Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia

Study Overview
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Brief Summary
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A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)

Detailed Description
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This is an open label phase II clinical study to evaluate the safety and pharmacokinetics of oral encochleated Amphotericin B (CAMB/MAT2203) for prevention of invasive fungal infections in approximately 30 patients undergoing induction therapy for AML/ALL.

Official Title
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An Open Label Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous (AML) and Lymphoblastic Leukaemia (ALL)

Conditions
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Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: Oral Encochleated Amphotericin B (CAMB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed AML/ALL receiving chemotherapy inducing neutropenia < 500 cells/mm3 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: Known hypersensitivity to amphotericin B, specifically anaphylactic reaction 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-randomized, open uncontrolled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAMB 200 mg<br>200 mg CAMB (MAT2203) Oral Amphotericin B | Drug: Oral Encochleated Amphotericin B (CAMB)<br>* Lipid-crystal nano-particle formulation amphotericin B<br>* Other names: MAT2203;|
| Experimental: CAMB 400 mg<br>400 mg CAMB (MAT2203) Oral Amphotericin B | Drug: Oral Encochleated Amphotericin B (CAMB)<br>* Lipid-crystal nano-particle formulation amphotericin B<br>* Other names: MAT2203;|
| Experimental: CAMB 800mg<br>800 mg CAMB (MAT2203) Oral Amphotericin B | Drug: Oral Encochleated Amphotericin B (CAMB)<br>* Lipid-crystal nano-particle formulation amphotericin B<br>* Other names: MAT2203;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events | Safety assessments include laboratory tests, vital signs, physical exam and ECG | 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Population pharmacokinetic (PK) analysis | PK parameter for Time to maximum concentration (Tmax) | 35 days | 
| Population pharmacokinetic (PK) analysis | PK parameter for Peak plasma concentration (Cmax) | 35 days | 
| Population pharmacokinetic (PK) analysis | PK parameter for Area under the plasma concentration time curve (AUC) | 35 days | 
| Efficacy analysis for time to clinical symptoms of fungal infection | Clinical symptoms of fungal infections include evaluation of respiratory symptoms, sinuses, skin. | 35 days |