Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263387
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-12-14
Brief Title:
Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia AML Patients Ineligible for Intensive Chemotherapy IC Treated With Venetoclax Azacitidine
Sponsor:
French Innovative Leukemia Organisation
Organization:
French Innovative Leukemia Organisation
Study Overview
Official Title:
Results From a Nationwide Cohort Temporary Utilization Authorization ATU of First-line Acute Myeloid Leukemia AML Patients Ineligible for Intensive Chemotherapy ICTreated in France With Venetoclax Azacitidine
Status:
RECRUITING
Status Verified Date:
2024-07
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:
VENAZA
Brief Summary:
Following the results of the phase 1b and the phase 3 studies VenetoclaxAzacitidine VENAZA was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program
Venetoclax VEN has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price Between February 15 2021 and June 30 2021 285 requests for ATU were made to the pharmaceutical company Abbvie and led to the initiation of treatment of more than 230 patients At the end of ATU period all these 230 ATU patients continued to be treated by VENAZA as part of the current post-ATU period Healthcare professionals and health care decision makers need real world data to better understand the benefitrisk profile of treatment Early access to treatment in France is close to real-life setting condition
Venetoclax VEN has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price Between February 15 2021 and June 30 2021 285 requests for ATU were made to the pharmaceutical company Abbvie and led to the initiation of treatment of more than 230 patients At the end of ATU period all these 230 ATU patients continued to be treated by VENAZA as part of the current post-ATU period Healthcare professionals and health care decision makers need real world data to better understand the benefitrisk profile of treatment Early access to treatment in France is close to real-life setting condition
Detailed Description:
None
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