Monocentric Phase 1 Study With Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM

RC22_0233

This is a phase 1 dose escalation study testing the addition of an anti-IL6 (siltuximab) to standard induction chemotherapy for high-risk AML.

2023-03-16

2025-06-30

2025-06-30

Recruiting

Early phase I

12

Inclusion Criteria: * age \>= 18 years * AML with a poor prognosis defined according to the criteria below: LAM First line: Age \<60 years and unfavorable risk according to the 2017 ELN Age\> = 60 years old and intermediate or unfavorable risk according to the ELN 2017 LAM in Relapse: whatever the age * ECOG \<= 2 * Patient eligible for intensive chemotherapy * Informed consent * Liver function tests: transaminases \<3x normal, bilirubin \<1.5X normal * Creatinine clearance\> 60ml / min * LVEF\> = 50% Exclusion Criteria: * Patients with FLT3 ITD or TKD mutation eligible for FLT3 inhibitor therapy * Uncontrolled infection * Hep B, C, HIV + * History of diverticulosis / diverticulitis * Patients at high risk of gastrointestinal perforation * No social security or any other scheme * Pregnant women or patient unable to take contraception (pill, abstinence, IUD not allowed) in case of fertility. contraceptive pill, abstinence, unauthorised IUD) in case of fertility. A patient who cannot continue contraception for at least 3 months after the last SILTUXIMAB injection is not eligible for inclusion. * Lactating women * Minors * Adults under guardianship, curatorship or legal protection * Hypersensitivity to one of the active substances or to one of the excipients

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2023-04-06