Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04547062
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2020-09-04
Brief Title:
Monocentric Phase 1 Study With Escalation of Doses of Tocilizumab in Combination With Chemotherapy Idarubicin and Cytarabine in Patients With Acute Myeloblastic Leukemia AML
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Monocentric Phase 1 Study With Escalation of Doses of Tocilizumab in Combination With Chemotherapy Idarubicin and Cytarabine in Patients With Acute Myeloblastic Leukemia AML With Poor Prognosis TOCILAM
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Tocilam
Brief Summary:
This is a phase 1 dose escalation study testing the addition of an anti-IL6 tocilizumab to standard induction chemotherapy for high-risk AML
Detailed Description:
Administration of tocilizumab at day 8 of induction following a classical induction using idarubicin 8mgm2d for 5 days and cytarabine 100mgm2d for 7 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003209-77 | EUDRACT_NUMBER | None | None |