A Phase II, Open-Label Randomized Study of Intravenous Tambiciclib in Combination with the Standard of care Venetoclax and Azacitidine in Patients with Newly Diagnosed AML Who Failed to Achieve at Least MLFS After the First Two Cycles of Treatment with Venetoclax and Azacitidine Alone

INTERVENTION: Product Name: TAMBICICLIB 100 mg/10 mL, Solution for Injection, Product Code:PRD13422875, Pharmaceutical Form: SOLUTION FOR INJECTION/INFUSION, Other descriptive name: , Strength: , Product Name: , Product Code:SCP184620, Pharmaceutical Form: , Other descriptive name: , Strength: , Product Name: TAMBICICLIB 100 mg/20 mL, Solution for Injection, Product Code:PRD13394278, Pharmaceutical Form: SOLUTION FOR INJECTION/INFUSION, Other descriptive name: , Strength: , Product Name: , Product Code:SCP16272936, Pharmaceutical Form: , Other descriptive name: , Strength: CONDITION: Acute myeloid leukemia ; MedDRA version: 28.1Level: LLTClassification code: 10000886Term: Acute myeloid leukemia Class: 10029104 Therapeutic area: Diseases [C] ‐ Neoplasms [C04] PRIMARY OUTCOME: Main Objective: To evaluate efficacy of Tambiciclib as an add on to standard VEN+AZA therapy in patients who did not respond with at least MLFS to the first two cycles of treatment with standard Ven+Aza therapy. Primary end point(s): Difference in Overall response rate (ORR) at course 2 defined as Complete response (CR) rate + Complete hematological response (CRh) + complete response with incomplete hematologic recovery (CRi) rate + Morphologic leukemia free state (MLFS) rate according ELN 2022 definition. Secondary Objective: To evaluate the safety and tolerability of Tambiciclib in combination with VEN+AZA, To compare event‐free survival (EFS) between patients treated with or without Tambiciclib., To compare overall survival (OS) between patients treated with or without Tambiciclib. SECONDARY OUTCOME: Secondary end point(s):Event‐free survival defined as time from C1D1 to treatment failure, relapse or death from any reason. Treatment failure is defined as lack of response (no achievement of at least MLFS) after second treatment cycle. Secondary end point(s):Overall survival defined as time from C1D1 to death from any reason. Secondary end point(s):Proportion of patients experiencing adverse events (AE) and severe adverse events (SAE) graded according to NCI‐CTCAE 5.0. INCLUSION CRITERIA: Male or female = 18 years, Female patients of childbearing potential (WOBC) must accept and be compliant with a highly effective contraceptive method (APPENDI XF) during treatment and up to 6 months after last administration of study drug. Since no sufficient data are available on the interaction between tambiciclib and hormonal contraceptives, if hormonal contraceptive methods are used, also a barrier method (condom) is required., For woman of childbearing potential (WOCBP), a negative serum pregnancy test must be confirmed prior to first dose., Male patients whose partner is a pregnant woman or a WOBC must use a condom during treatment and up to 3 months after last administration of study drug., WOBC and male patients whose partner is a pregnant woman or a WOBC must be informed and must accept and be compliant with no gamete donation (sperm/egg) during treatment and through the full contraception follow up period., Participant is willing and able to give informed