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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501171-14-00 | Other Identifier | EU CT number |
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This is a phase 1 dose escalation study testing the addition of an anti-IL6 (siltuximab) to standard induction chemotherapy for high-risk AML.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SILTUXIMAB | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siltuximab | Drug | Administration of siltuximab at day 8 of induction following a classical induction; 3 dose levels : 7, 9 and 11mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of DLT | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 30 and Day 45 |
| Evaluation of response at D15 after induction |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MARION GAUTIER | Contact | +33253526204 | marion.gautier@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Recruiting | Nantes | 44093 | France |
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percent bone marrow blasts at D15 (myelogram) |
| Day 15 |
| Assessment of myelotoxicity | Neutrophil recovery time (>1.0 × 109/L) from D1; Platelet recovery time (>100 × 109/L) from D1 | Day 45 |
| Overall survival | delay from D1 of induction to date of last news or death | 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 | Month 6 |
| Event-free survival | delay between D1 of induction and the date of relapse, death or date of last | Month 6 |
| Incidence of relapse if remission | relapse rate at last follow-up | Month 6 |
| Infections | monitoring of AEs infection | Month 6 |
| Cytokine levels: FLT3L and IL-6 | Cytokine levels: FLT3L and IL-6 | Day 1, Day 8, Day 15, Day 22 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C504234 | siltuximab |
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