Acute Myeloid Leukemia (AML)
Conditions
Keywords
AML il-6 tocilizumab
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.
Interventions
DRUGTocilizumab
Administration of tocilizumab at day 8 of induction following a classical induction
Sponsors
Nantes University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Continual Reassessment Method for MTD
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of DLT | 45 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of response | 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 death | 30 months |
| number of days between remission and relapse | 30 months |
| number of days between remission and death | 30 months |
| number of days between remission and last follow-up date | 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 days between Day 1 and relapse | 30 months |
| number of relapse | 30 months |
| Number of cytokine | 25 months |
| Number of tocilizumab | 25 months |
Countries
France
Outcome results
None listed