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

Sponsor
Nantes University Hospital
Study ID
NCT04547062
Phase
PHASE1
Status
Completed

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Administration of tocilizumab at day 8 of induction following a classical induction

Study Details

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

Key Dates

Start date
Dec 29, 2020
Status verified
Apr 2023
Primary completion
Apr 4, 2023
Completion
Apr 4, 2023

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Primary Outcome Measure

number of DLT [ Time Frame: 45 days ]

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