Study of Chinese Newly Diagnosed Participants With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

June 21, 2022 updated by: Bristol-Myers Squibb

Treatment Pattern, Clinical Outcome and Healthcare Resource Utilization Associated With Chinese Newly Diagnosed Patients With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP): A Retrospective Observational Study

Observational medical record review of newly diagnosed CML-CP participants in China

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

463

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Multi-center, observational, medical record review of approximately 1000 newly diagnosed CML-CP patients in China

Description

Inclusion Criteria:

  • Ph+ CML-CP patients who were diagnosed between August 1, 2014 to August 1, 2016
  • 18 years or older at time of diagnosis

Exclusion Criteria:

  • Participants once enrolled in any interventional clinical trial for CML
  • Participants whose records are not available

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants newly diagnosed with CML-CP
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants receiving each first-line treatment option
Time Frame: 2 years
2 years
Number of participants with complete cytogenetic response
Time Frame: 2 years
Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow (BM)
2 years
Number of participants with major molecular response (MMR)
Time Frame: 2 years
Major molecular response (MMR) is defined as 3-log reduction in International Scale of BCR-ABL mRNA
2 years
Number of participants of each initial dose schema
Time Frame: 2 years
2 years
Starting dose of each first-line agent
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of demographic characteristics
Time Frame: 2 years
Including age, sex, height, weight
2 years
Distribution of clinical characteristics
Time Frame: 2 years
Including health insurance and comorbid conditions
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2017

Primary Completion (Actual)

June 7, 2019

Study Completion (Actual)

September 28, 2019

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA180-681

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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