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 PhasePhiladelphia ChromosomeChronic Myeloid Leukemia
- 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
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
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants receiving each first-line treatment option 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 of each initial dose schema 2 years 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
Starting dose of each first-line agent 2 years
- 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
Local Institution🇨🇳Tianjin, Tianjin, China