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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524725-41-00 | EU Trial (CTIS) Number |
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This is a phase 1, open label, interventional, single center, in patients with Acute Myeloid Leukemia (AML). This study will investigate dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy.
The patient population will consist of adults men and women at least 18 years, who meet eligibility criteria. In this study propose combining tocilizumab with the standard treatment of azacitidine and venetoclax for patients with AML who are not eligible for intensive treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| increase dose of tocilizumab | Drug | Combining tocilizumab with the standard treatment of azacitidine and venetoclax |
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| Measure | Description | Time Frame |
|---|---|---|
| DLT | number of DLT | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| response to treatment | number of response | 28 months |
| response to treatment | number of response without detectable residual disease | 28 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peterlin Pierre | Contact | 02 40 08 74 018 | +33 | pierre.peterlin@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU of Nantes | Nantes | 44000 | France |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Death | number of days between Day 1 and Death | 48 months |
| follow - up | number of days between Day 1 and follow - up date | 48 months |
| relapse | number of days between remission day 1 and relapse | 48 months |
| death | number of days between remission and death | 48 months |
| follow up | number of days between remission and follow - up date | 48 months |
| relapse | number of days between remission and relapse | 48 months |
| relapse | number of relapse | 48 months |
| neutrophil | number of days of neutrophil recovery | 48 months |
| platelets | number of days of platelets recovery | 48 months |
| infection | number of infection | 48 months |
| cytokine | number of cytokine | 48 months |
| tocilizumab | number of tocilizumab | 48 months |