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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03509896
Enrollment
463
Registered
2018-04-26
Start date
2017-11-30
Completion date
2019-09-28
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia, Chronic Myeloid Leukemia in Chronic Phase, Philadelphia Chromosome

Brief summary

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

Interventions

OTHERNon-Interventional

Non-Interventional

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with complete cytogenetic response2 yearsComplete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow (BM)
Number of participants of each initial dose schema2 years
Starting dose of each first-line agent2 years
Number of participants receiving each first-line treatment option2 years
Number of participants with major molecular response (MMR)2 yearsMajor molecular response (MMR) is defined as 3-log reduction in International Scale of BCR-ABL mRNA

Secondary

MeasureTime frameDescription
Distribution of clinical characteristics2 yearsIncluding health insurance and comorbid conditions
Distribution of demographic characteristics2 yearsIncluding age, sex, height, weight

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026