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

Acute Myeloid Leukemia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03187691
• Other study ID #: MB-70006
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 2019
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: Matinas BioPharma Nanotechnologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Oral Encochleated Amphotericin B (CAMB)
Lipid-crystal nano-particle formulation amphotericin B

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Matinas BioPharma Nanotechnologies, Inc.	The Clinical Trials Centre Cologne, University of Cologne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events	Safety assessments include laboratory tests, vital signs, physical exam and ECG	35 days
Secondary	Population pharmacokinetic (PK) analysis	PK parameter for Time to maximum concentration (Tmax)	35 days
Secondary	Population pharmacokinetic (PK) analysis	PK parameter for Peak plasma concentration (Cmax)	35 days
Secondary	Population pharmacokinetic (PK) analysis	PK parameter for Area under the plasma concentration time curve (AUC)	35 days
Secondary	Efficacy analysis for time to clinical symptoms of fungal infection	Clinical symptoms of fungal infections include evaluation of respiratory symptoms, sinuses, skin.	35 days