Clinical trial · Interventional
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)
NCT03187691CI-TRIAL-00037515withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Protocol redundancy
Summary
Brief summary (as posted)
A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Encochleated Amphotericin B (CAMB) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- CAMB 200 mg
- description
- 200 mg CAMB (MAT2203) Oral Amphotericin B
- interventionNames
- Drug: Oral Encochleated Amphotericin B (CAMB)
- type
- EXPERIMENTAL
- label
- CAMB 400 mg
- description
- 400 mg CAMB (MAT2203) Oral Amphotericin B
- interventionNames
- Drug: Oral Encochleated Amphotericin B (CAMB)
- type
- EXPERIMENTAL
- label
- CAMB 800mg
- description
- 800 mg CAMB (MAT2203) Oral Amphotericin B
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.