Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05743465
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2023-02-14
Brief Title:
A Study to Evaluate Available Treatment Information of Ponatinib Bosutinib Imatinib Dasatinib and Nilotinib in Adults With Chronic Myeloid Leukemia
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Evaluate the Real-World Safety Outcomes and Clinical Efficacy of Ponatinib and Other Tyrosine Kinase Inhibitors Among Chronic Myeloid Leukemia Patients
Status:
COMPLETED
Status Verified Date:
2023-02
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:
None
Brief Summary:
The aims of this study are to learn out about treatment information including amongst others treatment patterns safety development of a participants condition ponatinib bosutinib imatinib dasatinib and nilotinib using already available data No new data will be collected from participants as part of this study and no study medicines will be provided in this study
Detailed Description:
This is a retrospective cohort analysis study in participants with chronic phase chronic myeloid leukemia CP-CML This study will use Humedica electronic medical record EMR data to evaluate the real-world treatment patterns safety and efficacy of ponatinib and other tyrosine kinase inhibitors TKIs among CP-CML participants
The study will enroll approximately 1769 patients Based on the TKI drug used on index date stratified by prior TKI use participants will be classified into the following cohorts -
Ponatinib Cohort
Bosutinib Cohort
Other TKI Cohort
This is a multicenter study conducted in the United States US The overall duration for data collection in this trial will be approximately 5 years
The study will enroll approximately 1769 patients Based on the TKI drug used on index date stratified by prior TKI use participants will be classified into the following cohorts -
Ponatinib Cohort
Bosutinib Cohort
Other TKI Cohort
This is a multicenter study conducted in the United States US The overall duration for data collection in this trial will be approximately 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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