Acute Myeloid Leukemia (AML)Phase 1SILTUXILAMNCT05697510
Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM
A Phase 1 study testing Siltuximab in people with Acute Myeloid Leukemia (AML), run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Siltuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2023to 30 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Liver function tests: transaminases <3x normal, bilirubin <1.5X normal
- Creatinine clearance> 60ml / min
- LVEF> = 50%
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Pierre PETERLIN, +33240083271, pierre.peterlin@chu-nantes.fr
About this study
Official title: 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
This is a phase 1 dose escalation study testing the addition of an anti-IL6 (siltuximab) to standard induction chemotherapy for high-risk AML.
Read the 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.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Siltuximab
- Keywords
- AML IL-6 SILTUXIMAB
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SiltuximabDrug
Administration of siltuximab at day 8 of induction following a classical induction; 3 dose levels : 7, 9 and 11mg/kg
| Study group | Role | What they receive |
|---|---|---|
| SILTUXIMAB | Experimental | Not described Receives: Drug: Siltuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of DLT
Measured: 45 days
Secondary outcomes (9)
Evaluation of the response to induction therapy with idarubicin + cytarabine + siltuximab
Calculation of complete remission (CR) and CR with incomplete recovery (CRi) according to the ELN 2017 definition
Measured: Day 30 and Day 45
Evaluation of response at D15 after induction
percent bone marrow blasts at D15 (myelogram)
Measured: Day 15
Assessment of myelotoxicity
Neutrophil recovery time (>1.0 × 109/L) from D1; Platelet recovery time (>100 × 109/L) from D1
Measured: Day 45
Overall survival
delay from D1 of induction to date of last news or death
Measured: Month 6
Leukaemia-free survival
delay between the date of CR and the date of relapse or death or the date of the last follow-up
Measured: Month 6
Event-free survival
delay between D1 of induction and the date of relapse, death or date of last
Measured: Month 6
Incidence of relapse if remission
relapse rate at last follow-up
Measured: Month 6
Infections
monitoring of AEs infection
Measured: Month 6
Cytokine levels: FLT3L and IL-6
Cytokine levels: FLT3L and IL-6
Measured: Day 1, Day 8, Day 15, Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start16 Mar 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697510
- Sponsor's protocol ID
- RC22_0233
- Other IDs
- 2022-501171-14-00
- Acronym
- SILTUXILAM
- Status last verified
- Apr 2023
- First submitted
- 11 Jan 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05697510
- Acronym / sponsor ID
- SILTUXILAM / RC22_0233
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- AML IL-6 SILTUXIMAB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SILTUXIMAB | Experimental | Drug: Siltuximab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SiltuximabAdministration of siltuximab at day 8 of induction following a classical induction; 3 dose levels : 7, 9 and 11mg/kg | Drug | SILTUXIMAB |
Primary outcome
number of DLT
Time frame: 45 days
9 secondary outcomes
Evaluation of the response to induction therapy with idarubicin + cytarabine + siltuximab
Time frame: Day 30 and Day 45
Evaluation of response at D15 after induction
Time frame: Day 15
Assessment of myelotoxicity
Time frame: Day 45
Overall survival
Time frame: Month 6
Leukaemia-free survival
Time frame: Month 6
Event-free survival
Time frame: Month 6
Incidence of relapse if remission
Time frame: Month 6
Infections
Time frame: Month 6
Cytokine levels: FLT3L and IL-6
Time frame: Day 1, Day 8, Day 15, Day 22
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Siltuximab in people with Acute Myeloid Leukemia (AML), run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARION GAUTIER (+33253526204, marion.gautier@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of DLT (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.