NCT03187691

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)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Matinas BioPharma Nanotechnologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Oral Encochleated Amphotericin B (CAMB)	Lipid-crystal nano-particle formulation amphotericin B

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2017-06-15
• Last updated: 2019-03-08

Regulatory

• FDA-regulated drug study