Monocentric Phase 1 Study With Escalation of Doses of Tocilizumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients With Acute Myeloblastic Leukemia (AML)

• Status: Recruiting
• Trial end date: 2023-06-15
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Nantes University Hospital

Criteria

Inclusion Criteria:

• 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:

• Uncontrolled infection

• Hep B, C, HIV +

• History of diverticulosis / diverticulitis

• No social security or any other scheme

• Pregnant women or patient unable to take contraception(contraceptive pill, abstinence, IUD unauthorized) in case of fertility. A patient who cannot continue contraception for at least 3 months after the last injection of TOCILIZUMAB is not eligible.

• Lactating women

• Minors

• Adults under guardianship, curatorship or legal protection

• Hypersensitivity to one of the active substances or to one of the excipients

• Patients with tuberculosis

• Patients documented with active COVID