This is a phase 1 dose escalation study testing the addition of an anti-IL6 (tocilizumab) to standard induction chemotherapy for high-risk AML.
Administration of tocilizumab at day 8 of induction following a classical induction using idarubicin 8mg/m2/d for 5 days and cytarabine 100mg/m2/d for 7 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Administration of tocilizumab at day 8 of induction following a classical induction
CHU of Nantes
Nantes, France
number of DLT
Time frame: 45 days
Number of response
Time frame: 25 months
Percentage of medullary blaste
Time frame: 24 months
number of days of neutrophil recovery
Time frame: 30 months
number of days of platelets recovery
Time frame: 30 months
Number of death
Time frame: 30 months
number of days between remission and relapse
Time frame: 30 months
number of days between remission and death
Time frame: 30 months
number of days between remission and last follow-up date
Time frame: 30 months
number of days between Day 1 and last follow-up date
Time frame: 30 months
number of days between Day 1 and death
Time frame: 30 months
number of days between Day 1 and relapse
Time frame: 30 months
number of relapse
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Time frame: 30 months
Number of cytokine
Time frame: 25 months
Number of tocilizumab
Time frame: 25 months