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

Matinas BioPharma

Status and phase: Withdrawn; Phase 2

Conditions: Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

Treatments: Drug: Oral Encochleated Amphotericin B (CAMB)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03187691

MB-70006

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

CAMB 200 mg

Experimental group

Description:

200 mg CAMB (MAT2203) Oral Amphotericin B

Treatment:

Drug: Oral Encochleated Amphotericin B (CAMB)

CAMB 400 mg

Experimental group

Description:

400 mg CAMB (MAT2203) Oral Amphotericin B

Treatment:

Drug: Oral Encochleated Amphotericin B (CAMB)

CAMB 800mg

Experimental group

Description:

800 mg CAMB (MAT2203) Oral Amphotericin B

Treatment:

Drug: Oral Encochleated Amphotericin B (CAMB)