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NCT03509896 Clinical Trial

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

Chronic Myeloid Leukemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03509896
Other study ID # CA180-681
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2017
Est. completion date September 28, 2019

Study information
Verified date June 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 463
Est. completion date September 28, 2019
Est. primary completion date June 7, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations
Country Name City State
China Local Institution Tianjin Tianjin

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants receiving each first-line treatment option 2 years
Primary Number of participants with complete cytogenetic response Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow (BM) 2 years
Primary Number of participants with major molecular response (MMR) Major molecular response (MMR) is defined as 3-log reduction in International Scale of BCR-ABL mRNA 2 years
Primary Number of participants of each initial dose schema 2 years
Primary Starting dose of each first-line agent 2 years
Secondary Distribution of demographic characteristics Including age, sex, height, weight 2 years
Secondary Distribution of clinical characteristics Including health insurance and comorbid conditions 2 years
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