Clinical trial

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

Name

RC20_0282

Description

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

Trial arms

Trial start

2020-12-29

Estimated PCD

2023-04-04

Trial end

2023-04-04

Status

Completed

Phase

Early phase I

Treatment

Tocilizumab

Administration of tocilizumab at day 8 of induction following a classical induction

Size

Primary endpoint

number of DLT

45 days

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Continual Reassessment Method for MTD', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

Updated at

2023-04-28

1 organization

1 drug

1 abstract

1 indication

Organization

Nantes University Hospital

Drug

Tocilizumab

Indication

Acute Myeloid Leukemia

Abstract

First-in-human trial of tocilizumab in combination with a standard induction chemotherapy in newly diagnosed acute myeloid leukemia patients: The phase 1 TOCILAM study.

Org: CHU de Nantes, Hôpital Hôtel-Dieu, Nantes, France, Service d'Hématologie Clinique - CHU Pontchaillou, Hotel Dieu - HME, Clinical Research Centre, Departmental Hospital Centre,