Leukemia Acute Myeloid - AML
Conditions
Keywords
Leukemia, IL6, tocilizumab
Brief summary
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.
Interventions
DRUGincrease dose of tocilizumab
Combining tocilizumab with the standard treatment of azacitidine and venetoclax
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* First-line AML regardless of karyotype and molecular profile * ECOG \<= 3 * Patient eligible for chemotherapy combining azacitidine and venetoclax * Informed consent * Liver function tests: transaminases \< 3x normal, bilirubin \< 1.5x normal * Creatinine clearance \> 30 ml/min
Exclusion criteria
* LAM3 * Patients eligible for intensive "3+7" treatment * Uncontrolled infection * Active and/or treated infection with Hep B, C, or HIV * No social security or other health insurance * Pregnant women or patients who cannot use contraception due to fertility * Breastfeeding women * Minors * Adults under guardianship, conservatorship, or legal protection * Hypersensitivity to any of the active substances or excipients (see SPCs) * Patients unable to understand spoken or written French
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT | 42 days | number of DLT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| response to treatment | 28 months | number of response |
| Death | 48 months | number of days between Day 1 and Death |
| follow - up | 48 months | number of days between Day 1 and follow - up date |
| relapse | 48 months | number of days between remission day 1 and relapse |
| death | 48 months | number of days between remission and death |
| follow up | 48 months | number of days between remission and follow - up date |
| neutrophil | 48 months | number of days of neutrophil recovery |
| platelets | 48 months | number of days of platelets recovery |
| infection | 48 months | number of infection |
| cytokine | 48 months | number of cytokine |
| tocilizumab | 48 months | number of tocilizumab |
Countries
France
Contacts
CONTACTPeterlin Pierre
Outcome results
None listed