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Trial Title:
Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM
NCT ID:
NCT05697510
Condition:
Acute Myeloid Leukemia (AML)
Conditions: Official terms:
Leukemia
Leukemia, Myeloid, Acute
Siltuximab
Conditions: Keywords:
AML IL-6 SILTUXIMAB
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Siltuximab
Description:
Administration of siltuximab at day 8 of induction following a classical induction; 3
dose levels : 7, 9 and 11mg/kg
Arm group label:
SILTUXIMAB
Summary:
This is a phase 1 dose escalation study testing the addition of an anti-IL6 (siltuximab)
to standard induction chemotherapy for high-risk AML.
Detailed description:
Administration of siltuximab 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- age >= 18 years
- 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:
- Patients with FLT3 ITD or TKD mutation eligible for FLT3 inhibitor therapy
- Uncontrolled infection
- Hep B, C, HIV +
- History of diverticulosis / diverticulitis
- Patients at high risk of gastrointestinal perforation
- No social security or any other scheme
- Pregnant women or patient unable to take contraception (pill, abstinence, IUD not
allowed) in case of fertility. contraceptive pill, abstinence, unauthorised IUD) in
case of fertility. A patient who cannot continue contraception for at least 3 months
after the last SILTUXIMAB injection is not eligible for inclusion.
- Lactating women
- Minors
- Adults under guardianship, curatorship or legal protection
- Hypersensitivity to one of the active substances or to one of the excipients
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Nantes
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre PETERLIN
Phone:
+33240083271
Email:
pierre.peterlin@chu-nantes.fr
Start date:
March 16, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Nantes University Hospital
Agency class:
Other
Source:
Nantes University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05697510
