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

• Status: Not yet recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Siltuximab

Criteria

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