Study With Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia

Sponsor
Nantes University Hospital
Study ID
NCT07392814
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Leukemia Acute Myeloid - AML

Eligibility Criteria

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

Interventions

Study Details

This is a phase 1, open label, interventional, single center, in patients with Acute Myeloid Leukemia (AML). This study will investigate dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy. The patient population will consist of adults men and women at least 18 years, who meet eligibility criteria. In this study propose combining tocilizumab with the standard treatment of azacitidine and venetoclax for patients with AML who are not eligible for intensive treatment.

Key Dates

Start date
Mar 10, 2026
Status verified
Jan 2026
Primary completion
Jul 10, 2028
Completion
Jul 10, 2030

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    * Level 1: 4 mg/kg on Day 1 of cycles 1 to 3 * Level 2: 6 mg/kg on Day 1 of cycles 1 to 3 (starting dose for the first cohort) * Level 3: 8 mg/kg on Day 1 of cycles 1 to 3 * Level 4: 4 mg/kg on Days 1 and 15 of cycles 1 to 3

Primary Outcome Measure

DLT [ Time Frame: 42 days ]

Central Contacts