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

Nantes University Hospital (NUH)

Status and phase

Completed

Phase 1

Conditions

Acute Myeloid Leukemia (AML)

Treatments

Drug: Tocilizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT04547062

RC20_0282

2020-003209-77 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Administration of tocilizumab 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 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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