Viewing Study NCT06297161



Ignite Creation Date: 2024-05-06 @ 8:13 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06297161
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-07
First Post: 2024-02-29

Brief Title: A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid LeukemiaCML
Sponsor: Pfizer
Organization: Pfizer

Study Overview

Official Title: Post Marketing Surveillance Study to Observe Safety and Effectiveness of BOSULIF
Status: NOT_YET_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: None
Brief Summary: The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice

This study is seeking for participants who are

Adult Patients who are just confirmed to have Chronic Myeloid Leukemia CML defined in Local Product Document LPD CML is a type of cancer that starts in the blood-forming cells of the bone marrow and invades the blood LPD explains what a medicines benefits and problems are LPD also explains how to use the medicine correctly in Korea
willing to take part in the study after being informed about the study All participants in this study will receive bosulif All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD The participants will be treated with bosulif under routine clinical practice in Korea

The study will look at the experiences of people receiving the study medicine This will help to see if the study medicine is safe and effective

In this study all treatment and checking of the patients will be done as per the study doctor The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None