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

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: Chronic Myeloid Leukemia; Philadelphia Chromosome; Chronic Myeloid Leukemia in Chronic Phase
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Actual): 463

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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		2 years
Number of participants with complete cytogenetic response	Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow (BM)	2 years
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
Number of participants of each initial dose schema		2 years
Starting dose of each first-line agent		2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

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: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Chromosome Aberrations; Translocation, Genetic; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
• 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