NCT06621199 Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

Trial Parameters

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Brief Summary

This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).

Eligibility Criteria

Inclusion Criteria: 1. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. 2. Aged 60-70 years (including boundary values 60 and 70); 3. Newly diagnosed primary AML according to the WHO 2022 classification. 4. Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2. 5. Life expectancy ≥ 3 months. 6. ALT/AST≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN. Exclusion Criteria: 1. Subjects meet any of the following conditions: 1. Acute promyelocytic leukemia; 2. Secondary AML caused by chemotherapy and/or radiotherapy to treat solid tumor or antecedent hematological disorders such as MDS, MPN, MDS/MPN; 3. AML following blast transformation of prior chronic myeloid leukemia; 4. Central nervous system (CNS) leukemia; 2. Subjects with

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