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

Completed

• Conditions: Chronic Myeloid Leukemia in Chronic Phase; Philadelphia Chromosome; Chronic Myeloid Leukemia
• Interventions: Other: Non-Interventional

• Registration Number: NCT03509896
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-11-30
• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-26
• Primary Completion: 2019-06-07
• Study Completion: 2019-09-28
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 463

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants newly diagnosed with CML-CP	Non-Interventional	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Distribution of clinical characteristics	2 years	Including health insurance and comorbid conditions
Distribution of demographic characteristics	2 years	Including age, sex, height, weight

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Tianjin, Tianjin, China