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
Last Updated: 2023-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
2023-03-16
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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SILTUXIMAB
Siltuximab
Administration of siltuximab at day 8 of induction following a classical induction; 3 dose levels : 7, 9 and 11mg/kg
Interventions
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Siltuximab
Administration of siltuximab at day 8 of induction following a classical induction; 3 dose levels : 7, 9 and 11mg/kg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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CHU de Nantes
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-501171-14-00
Identifier Type: OTHER
Identifier Source: secondary_id
RC22_0233
Identifier Type: -
Identifier Source: org_study_id
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