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

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)

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

Study Overview

• Status: Withdrawn
• Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia
• Intervention / Treatment: Drug: Oral Encochleated Amphotericin B (CAMB)

Detailed 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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Matinas BioPharma Nanotechnologies, Inc.
• Collaborators: University of Cologne; The Clinical Trials Centre Cologne
• Investigators: Principal Investigator: Oliver Cornely, MD, University of Cologne

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Anti-Infective Agents; Anti-Bacterial Agents; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Amebicides; Amphotericin B; Liposomal amphotericin B
• Other Study ID Numbers: MB-70006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No