Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM
SILTUXILAM
Monocentric Phase 1 Study With Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM
2 other identifiers
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedStudy Start
First participant enrolled
March 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedApril 6, 2023
April 1, 2023
2.3 years
January 11, 2023
April 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of DLT
45 days
Secondary Outcomes (9)
Evaluation of the response to induction therapy with idarubicin + cytarabine + siltuximab
Day 30 and Day 45
Evaluation of response at D15 after induction
Day 15
Assessment of myelotoxicity
Day 45
Overall survival
Month 6
Leukaemia-free survival
Month 6
- +4 more secondary outcomes
Study Arms (1)
SILTUXIMAB
EXPERIMENTALInterventions
Administration of siltuximab at day 8 of induction following a classical induction; 3 dose levels : 7, 9 and 11mg/kg
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
- Lactating women
- Minors
- Adults under guardianship, curatorship or legal protection
- Hypersensitivity to one of the active substances or to one of the excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nantes
Nantes, 44093, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2023
First Posted
January 26, 2023
Study Start
March 16, 2023
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
April 6, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share