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

• Status: Withdrawn
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Matinas BioPharma Nanotechnologies, Inc.
• Collaborators: The Clinical Trials Centre Cologne; University of Cologne
• Treatments: Amphotericin B; Antifungal Agents; Liposomal amphotericin B; Miconazole

Criteria

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