Safety and PK of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous and Lymphoblastic Leukaemia
NCT03187691 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2019-03-08
Summary
A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)
Conditions
Interventions
- DRUG
-
Oral Encochleated Amphotericin B (CAMB)
Lipid-crystal nano-particle formulation amphotericin B
Sponsors & Collaborators
-
University of Cologne
collaborator OTHER -
The Clinical Trials Centre Cologne
collaborator OTHER -
Matinas BioPharma Nanotechnologies, Inc.
lead INDUSTRY
Principal Investigators
-
Oliver Cornely, MD · University of Cologne
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-31
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
- FDA Drug
- Yes
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