Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Conditions
Brief 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.
Interventions
Lipid-crystal nano-particle formulation amphotericin B
Sponsors
University of Cologne
The Clinical Trials Centre Cologne
Matinas BioPharma Nanotechnologies, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Non-randomized, open uncontrolled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events | 35 days | Safety assessments include laboratory tests, vital signs, physical exam and ECG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Population pharmacokinetic (PK) analysis | 35 days | PK parameter for Time to maximum concentration (Tmax) |
| Efficacy analysis for time to clinical symptoms of fungal infection | 35 days | Clinical symptoms of fungal infections include evaluation of respiratory symptoms, sinuses, skin. |
Outcome results
None listed