Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05319587 | Study of Liposomal Annamycin in Combination With Cytarabine for the Treatment of Subjects With Acute Myeloid Leukemia (AML) | PHASE1 | COMPLETED | 22 | — | — | Sep 29, 2022 | Aug 10, 2023 | Sep 30, 2025 | 9 | Italy, Poland |
| NCT03388749 | Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) | PHASE1 | COMPLETED | 20 | — | — | Dec 17, 2018 | Feb 14, 2022 | Jan 20, 2023 | 5 | Poland |
| NCT03315039 | Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) | PHASE1 | COMPLETED | 7 | — | — | Mar 28, 2018 | Jun 20, 2020 | Mar 10, 2022 | 4 | United States |
The number of patients who experience dose-limiting toxicities (DLT) will be captured at each dose level of LAnnamycin in order to determine the MTD/RP2D
The number of patients who experience dose-limiting toxicities (DLT) will be captured at each dose level of L-Annamycin in order to determine the MTD/RP2D
Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated
| Arm | Type | Description |
|---|---|---|
| Liposomal annamycin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Liposomal Annamycin | DRUG | 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days). |
| Cytarabine | DRUG | Administered during cycle 1 at a dose of 2.0 g/m2/day by 4 hours IV infusion for 5 consecutive days and this dose will remain constant for all cohorts, including the expansion phase. |
Inclusion Criteria: 1. The subject has a pathologically confirmed diagnosis of AML by World Health Organization classification. This must be in the form of either a bone marrow aspirate or biopsy or a CBC that demonstrates \>5% myeloblasts. 2. The subject has AML and has not received prior therapy ...