Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML

Summary

This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML). This study includes the induction and consolidation phases of AML treatment.

Eligibility

Inclusion Criteria:

* Newly diagnosed primary AML patients. Diagnostic criteria refer to the 2022 WHO classification.
* Age between 18 and 60 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 2).
* Cardiac ultrasound LVEF ≥ 45%.
* Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured using a 24-hour urine sample).
* Liver function: Aspartate aminotransferase (AST) ≤ 2.5 × ULN\*; Alanine aminotransferase (ALT) ≤ 2.5 × ULN\*; Total bilirubin ≤ 1.5 × ULN\* (\*unless considered due to leukemia infiltration).
* Signed informed consent form.

Exclusion Criteria:

* Acute promyelocytic leukemia (APL).
* Relapsed/refractory AML patients.
* AML patients with known involvement of the central nervous system (CNS).
* Known HIV-infected participants (due to potential drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be conducted during screening according to local guidelines or institutional standards.Participants with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Non-active carriers of viral hepatitis or participants with low viral hepatitis viral titers after receiving non-prohibited antiviral therapy will not be excluded.
* Participants who have received strong or moderate CYP3A inducers/inhibitors therapy within 7 days prior to starting study treatment.
* Participants with New York Heart Association (NYHA) functional classification \> Grade 2. Grade 2 is defined as patients having cardiac disease with no symptoms at rest but experiencing fatigue, palpitations, dyspnea, or angina with ordinary physical activity.
* Participants with chronic respiratory disease requiring continuous oxygen therapy.
* Patients unable to take oral medications or with malabsorption syndrome.
* Presence of uncontrolled systemic infection (viral, bacterial, or fungal).
* Participants who have previously received venetoclax treatment and/or are currently participating in any other study involving investigational drugs.

Conditions2

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