About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
First-line AML regardless of karyotype and molecular profile
ECOG <= 3
Patient eligible for chemotherapy combining azacitidine and venetoclax
Informed consent
Disqualifiers
LAM3
Patients eligible for intensive "3+7" treatment
Uncontrolled infection
Active and/or treated infection with Hep B, C, or HIV
Trial design
Single group
Treatments tested in this trial
increase dose of tocilizumab
DrugCombining tocilizumab with the standard treatment of azacitidine and venetoclax
Treatment groups
Trial outcomes
Primary outcomes
DLT
number of DLT
Secondary outcomes
response to treatment
number of response
response to treatment
number of response without detectable residual disease
Death
number of days between Day 1 and Death
follow - up
number of days between Day 1 and follow - up date
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: