Monocentric Phase 1 Study With Escalation of Doses of Tocilizumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients With Acute Myeloblastic Leukemia (AML) (Tocilam)
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Monocentric Phase 1 Study With Escalation of Doses of Tocilizumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients With Acute Myeloblastic Leukemia (AML) With Poor Prognosis: TOCILAM"
Actual Study Start Date :
December 29, 2020
Actual Primary Completion Date :
April 4, 2023
Actual Study Completion Date :
April 4, 2023
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
- AML with a poor prognosis defined according to the criteria below: LAM First line: Age <60 years and unfavorable risk according to the 2017 ELN Age> = 60 years old and intermediate or unfavorable risk according to the ELN 2017 LAM in Relapse: whatever the age
ECOG <= 2
Patient eligible for intensive chemotherapy
Liver function tests: transaminases <3x normal, bilirubin <1.5X normal
Creatinine clearance> 60ml / min
LVEF> = 50%
Hep B, C, HIV +
History of diverticulosis / diverticulitis
No social security or any other scheme
Pregnant women or patient unable to take contraception(contraceptive pill, abstinence, IUD unauthorized) in case of fertility. A patient who cannot continue contraception for at least 3 months after the last injection of TOCILIZUMAB is not eligible.
Adults under guardianship, curatorship or legal protection
Hypersensitivity to one of the active substances or to one of the excipients