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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Combining tocilizumab with the standard treatment of azacitidine and venetoclax
CHU of Nantes
Nantes, France
DLT
number of DLT
Time frame: 42 days
response to treatment
number of response
Time frame: 28 months
response to treatment
number of response without detectable residual disease
Time frame: 28 months
Death
number of days between Day 1 and Death
Time frame: 48 months
follow - up
number of days between Day 1 and follow - up date
Time frame: 48 months
relapse
number of days between remission day 1 and relapse
Time frame: 48 months
death
number of days between remission and death
Time frame: 48 months
follow up
number of days between remission and follow - up date
Time frame: 48 months
relapse
number of days between remission and relapse
Time frame: 48 months
relapse
number of relapse
Time frame: 48 months
neutrophil
number of days of neutrophil recovery
Time frame: 48 months
platelets
number of days of platelets recovery
Time frame: 48 months
infection
number of infection
Time frame: 48 months
cytokine
number of cytokine
Time frame: 48 months
tocilizumab
number of tocilizumab
Time frame: 48 months
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