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Protocol redundancy
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| Name | Class |
|---|---|
| University of Cologne | OTHER |
| The Clinical Trials Centre Cologne | OTHER |
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A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAMB 200 mg | Experimental | 200 mg CAMB (MAT2203) Oral Amphotericin B |
|
| CAMB 400 mg | Experimental | 400 mg CAMB (MAT2203) Oral Amphotericin B |
|
| CAMB 800mg | Experimental | 800 mg CAMB (MAT2203) Oral Amphotericin B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Encochleated Amphotericin B (CAMB) | Drug | Lipid-crystal nano-particle formulation amphotericin B |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events | Safety assessments include laboratory tests, vital signs, physical exam and ECG | 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Population pharmacokinetic (PK) analysis | PK parameter for Time to maximum concentration (Tmax) | 35 days |
| Population pharmacokinetic (PK) analysis | PK parameter for Peak plasma concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Cornely, MD | University of Cologne | Principal Investigator |
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Non-randomized, open uncontrolled
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|
| 35 days |
| Population pharmacokinetic (PK) analysis | PK parameter for Area under the plasma concentration time curve (AUC) | 35 days |
| Efficacy analysis for time to clinical symptoms of fungal infection | Clinical symptoms of fungal infections include evaluation of respiratory symptoms, sinuses, skin. | 35 days |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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