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

Nantes University Hospital (NUH)

Status and phase: Enrolling; Phase 1

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Drug: Siltuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT05697510

2022-501171-14-00 (Other Identifier)

RC22_0233

Details and patient eligibility

About

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

Full description

Administration of siltuximab at day 8 of induction following a classical induction using idarubicin 8mg/m2/d for 5 days and cytarabine 100mg/m2/d for 7 days.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 1 patient group

SILTUXIMAB

Experimental group

Treatment:

Drug: Siltuximab