L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML

Inclusion criteria

• ✓. Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) as adopted in the European LeukemiaNet (ELN) 2022 recommendations for the diagnosis and management of AML. The tests and procedures used to establish the diagnosis of AML should be consistent with the ELN's 2022 recommendations
• ✓. Has refractory/relapsed AML after having received only one prior line of therapy\*.
• ✓. Between 18 and 80 years of age (inclusive) at the time of signing the informed consent form (ICF).
• ✓. Has received no chemotherapy, radiation, or major surgery within 2 weeks prior to the first randomized dose of study drug or has recovered from the toxic side effects of that therapy. Hydroxyurea to control white blood cell (WBC) count, supportive measures, and prophylaxes as required under the protocol will be allowed. Treatment of opportunistic or other infections with antibiotics, antifungals, and/or antiviral agents, including therapy for meningeal disease (i.e., intrathecal chemotherapy), per institutional standards of care will be allowed during this period, as long as the symptoms of infection have resolved by 1 week prior to the first dose of randomized study drug.
• ✓. Has received no investigational therapy within 4 weeks prior to the first randomized dose of study drug.
• ✓. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening.
• ✓. Has a life expectancy of greater than six weeks at screening.
• ✓. Has adequate laboratory results at screening including the following:

Exclusion criteria