Safety And Efficacy Of Bosutinib

The objective of this surveillance is to collect information about

1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction) 2. the incidence of adverse drug reactions in this surveillance 3. factors considered to affect the safety and/or efficacy of this drug.

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Key information

Conditions

Chronic Myelogenous Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The patients should be registered by central registration system.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chronic myelogenous leukemia patients resistant or intolerant to prior treatment there is no experience with this drug
Newly-diagnosed chronic phase Chronic myelogenous leukemia patients there is no experience with this drug

Exclusion criteria

Patients with a history of hypersensitivity
Women who may possibly be pregnant or become pregnant

Treatment and study plan

Bosutinib

Drug

The recommended adult dose of bosutinib is 500 mg orally once daily with food. For newly-diagnosed chronic phase CML, the recommended dose is 400 mg. The dose may be adjusted appropriately according to the patient's condition; however, the maximum dose is 600 mg once daily.

Other names: BOSULIF

Primary outcomes

The incidence of adverse drug reactions

Time frame: 24 weeks
Cytogenetic response

Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

DRUG USE INVESTIGATION OF BOSUTINIB FOR CML (POST MARKETING COMMITMENT PLAN)

Acronym: BLF

Important dates

Study start: 2015
Primary completion: 2024
Study completion: 2024
First posted: Jul 17, 2015
Registry last updated: Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed