Monocentric Phase 1 Study With Escalation of Doses of Tocilizumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients With Acute Myeloblastic Leukemia (AML)
Phase 1
Completed
- Conditions
- Acute Myeloid Leukemia (AML)
- Registration Number
- NCT04547062
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
This is a phase 1 dose escalation study testing the addition of an anti-IL6 (tocilizumab) to standard induction chemotherapy for high-risk AML.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- 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
- Informed consent
- Liver function tests: transaminases <3x normal, bilirubin <1.5X normal
- Creatinine clearance> 60ml / min
- LVEF> = 50%
Exclusion Criteria
- Uncontrolled infection
- 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.
- Lactating women
- Minors
- Adults under guardianship, curatorship or legal protection
- Hypersensitivity to one of the active substances or to one of the excipients
- Patients with tuberculosis
- Patients documented with active COVID
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method number of DLT 45 days
- Secondary Outcome Measures
Name Time Method number of days between remission and last follow-up date 30 months Number of response 25 months number of days between Day 1 and relapse 30 months number of relapse 30 months Number of cytokine 25 months Percentage of medullary blaste 24 months number of days of neutrophil recovery 30 months number of days of platelets recovery 30 months number of days between remission and relapse 30 months number of days between remission and death 30 months number of days between Day 1 and last follow-up date 30 months number of days between Day 1 and death 30 months Number of tocilizumab 25 months Number of death 30 months
Trial Locations
- Locations (1)
CHU of Nantes
🇫🇷Nantes, France