Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181734
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2023-11-27
Brief Title:
Ivosidenib TIBSOVO Combined With Azacitidine According to Current SmPC
Sponsor:
iOMEDICO AG
Organization:
iOMEDICO AG
Study Overview
Official Title:
Ivosidenib in Combination With Azacitidine as First-line Treatment for Adult Patients With Newly Diagnosed AML With an IDH1 R132 Mutation Who Are Not Eligible to Receive Standard Induction Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-06
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:
CONFIDHENCE
Brief Summary:
The goal of this non-interventional study is to evaluate quality of life QoL in adult patients with newly diagnosed IDH1 R132-mutated AML who are not eligible to receive standard induction chemotherapy and who are treated with ivosidenib in combination with azacitidine in a real-world setting in Germany
The main questions it aims to answer are
Evaluate QoL by validated and widely used Functional Assessment of Cancer Therapy - Leukemia FACT-Leu questionnaire and European Quality of Life 5 Dimensions 5 Level Version EQ-5D-5L questionnaire during treatment and follow-up period
Assesment of effectiveness in routine treatment eg overall survival event-free survival overall response rate
Assessment of drug safety all adverse events
Description of treatment reality in detail
The main questions it aims to answer are
Evaluate QoL by validated and widely used Functional Assessment of Cancer Therapy - Leukemia FACT-Leu questionnaire and European Quality of Life 5 Dimensions 5 Level Version EQ-5D-5L questionnaire during treatment and follow-up period
Assesment of effectiveness in routine treatment eg overall survival event-free survival overall response rate
Assessment of drug safety all adverse events
Description of treatment reality in detail
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