Clinical Research Directory

Inclusion Criteria: Participant must be 18 years of age inclusive Participants with confirmed diagnosis of relapsed or primary refractory acute myeloid leukemia (AML), according to World Health Organization (WHO) classification, including: * Participants with relapsed AML after allogeneic stem cells transplantation, including those who have received donor lymphocyte infusions, * Isolated central nervous system (CNS) or extramedullary disease, * At least 1 prior line of therapy which includes chemotherapy, hypomethylating agents, venetoclax or targeted therapy. Participants with a weight ≥42 kg. Exclusion Criteria: * Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed. * Known acquired immunodeficiency syndrome (AIDS-related illnesses) or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or having active hepatitis B or C infection, or symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. * Pregnant or breast-feeding women, female participants of childbearing potential, and male participants with female partners of childbearing potential who are not willing to avoid pregnancy by using a highly effective method of contraception (2 barrier method or 1 barrier method with a spermicide, intrauterine device, or hormonal contraception with inhibition of ovulation, for 2 weeks prior to the first dose of SAR445419, during treatment, and 6 months after the last dose of fludarabine). A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. * History of solid organ transplant, including corneal transplant. * Receiving at the time of first SAR445419 administration corticosteroid as a concomitant medication with corticosteroid dose \>10 mg/day of oral prednisone or the equivalent, except steroid inhaler, nasal spray, or ophthalmic solution * Known contraindication to any of the non-investigational medicinal products (NIMPs) (fludarabine, cytarabine, acetaminophen and diphenhydramine). * Concurrent treatment with other investigational drugs The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.