A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML).

Официальное название

Post Marketing Surveillance Study to Observe Safety and Effectiveness of BOSULIF

Обзор

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: 1. Patients who are being treated\* or will be treated with Bosulif according to it's local product document under routine clinical practice (\*Patients who initiated Bosulif treatment within one year before consent) 2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of 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.

Вмешательства

• Препарат Bosulif
  chronic myelogenous leukemia patients

Первичные конечные точки

• Incidence of AEs [Срок оценки: From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)]

Вторичные конечные точки (4)

• Hematologic response: CHR, not achieved [Срок оценки: From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)]
• Cytogenetic response: CCyR, PCyR, mCyR, not achieved [Срок оценки: From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)]
• Molecular response: 'Molecular response (MR) 1', 'MR 2', 'MR3/Major MR(MMR)', 'MR 4.0', 'MR4.5', 'MR5' [Срок оценки: From the date of bosulif treatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)]
• Relapse [Срок оценки: From the date of bosulif reatment completion until index period (Between 30 Dec 2022 and 29 Dec 2028)]

Критерии участия

Критерии включения

• Patients who are being treated\* or will be treated with Bosulif according to it's local product document under routine clinical practice (\*Patients who initiated Bosulif treatment within one year before consent)
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Критерии исключения

\- Patients to whom bosulif is contraindicated as per the local labeling- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Pfizer New York — New York

Идентификаторы

NCT: NCT06297161 · B1871065 · NCT06297161

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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