Combining Siltuximab with Chemotherapy for High-Risk Acute Myeloid Leukemia
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 study is testing if adding a new drug called siltuximab to standard chemotherapy can help people with high-risk acute myeloid leukemia feel better and improve their treatment results.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Drugs / interventions | SILTUXIMAB, chemotherapy |
| Locations | 1 site (Nantes) |
| Trial ID | NCT05697510 on ClinicalTrials.gov |
What this trial studies
This phase 1 trial investigates the safety and efficacy of adding siltuximab, an anti-IL6 agent, to standard chemotherapy regimens for patients with high-risk acute myeloid leukemia (AML). Participants will receive siltuximab on day 8 of their chemotherapy, which includes idarubicin and cytarabine. The study aims to determine the optimal dose of siltuximab that can be safely administered alongside these chemotherapeutic agents. The trial focuses on patients with poor prognostic factors to assess potential improvements in treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute myeloid leukemia classified as having a poor prognosis.
Not a fit: Patients with specific genetic mutations eligible for targeted therapies or those with uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment effectiveness and improve survival rates for patients with high-risk AML.
How similar studies have performed: While the combination of siltuximab with chemotherapy is a novel approach, previous studies have shown promise in targeting IL-6 in hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nantes
- CHU de Nantes — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Marion Gautier
- Email: marion.gautier@chu-nantes.fr
- Phone: +33253526204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.