Effectiveness of Dasatinib in Adult Patients With Chronic Myeloid Leukemia in China: A Multicenter, Registry Study

Study Overview
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Brief Summary
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The primary objective is to describe the effectiveness of dasatinib (Sprycel®) in CML patients in China in the real-world clinical practice setting.

Detailed Description
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Breakpoint cluster region (BCR) Abelson murine leukemia viral oncogene homolog 1 (c-ABL) Chronic myeloid leukemia (CML)

Official Title
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Effectiveness of Dasatinib(Sprycel®) in Adult Patients With Chronic Myeloid Leukemia in China: A Multicenter, Registry Study

Conditions
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention / Treatment
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* Drug: Dasatinib


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Because this is a product registry study, it will include adult CML patients in any phase treated with dasatinib in China if they meet the following criteria: Willing and able to provide written informed consent ≥18 years of age Confirmed diagnosis of CML patients by attending physician Naive to dasatinib before enrollment in study treatment or have received <3 months of dasatinib treatment Plan to or are receiving dasatinib therapy based on physician's clinical judgment Administered dasatinib after imatinib-resistance or intolerance Exclusion Criteria: - Patients participating in clinical trials for CML that explicitly prohibit recruitment in additional studies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CML patients treated with dasatinib<br>Cohort of chronic myeloid leukemia patients treated with second-line dasatinib (Sprycel) | Drug: Dasatinib<br> <br> * Other names: Sprycel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Hematologic response (HR) for Chronic phase (CP), Advanced phase (AP),Blast phase (BP) | Hematological Response is a normalization of the blood counts, particularly white blood cell counts. This is the first noticeable indicator that treatment is beginning to work, though not necessarily in the bone marrow | Upto 2 years | 
| Rate of Cytogenetic response (CR) for Chronic phase, Advanced phase,Blast phase | Cytogenetic Response is a response to treatment of CML that occurs in the marrow, rather than just in the blood | Upto 2 years | 
| Rate of Molecular response (MR) for Chronic phase,Advanced phase,Blast phase | Molecular response is defined as no detectable BCR-ABL observed through Quantitative polymerase chain reaction (Q-PCR) (International Scale) using an assay with a sensitivity of at least 4.5 logs below the standardized baseline | Upto 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic and baseline characteristics of patients using dasatinib including health insurance, concomitant regimens, risk scores, and comorbidities based on patient-reported questionnaire | Type and percentage of each variable: health insurance, concomitant regimens and comorbidities; patients distribution by Sokal score | Upto 2 years | 
| Dasatinib treatment pattern, including medication adherence and treatment interruption based on patient-reported questionnaire | Dasatinib starting dose and administration schedule, cumulative dose, maximum daily dose and duration of exposure; dose alterations (including changes in frequency, reductions and or delays) and reason(s) for dose alterations; discontinuation and reason(s) for dasatinib discontinuation | Upto 2 years | 
| Relationship between time to initiation of dasatinib after imatinib failure and best response to dasatinib |  | Upto 2 years | 
| Progression-free survival (PFS) |  | Upto 2 years | 
| Overall survival (OS) |  | Upto 2 years | 
| Safety of dasatinib measured by incidence and severity of adverse events |  | Upto 2 years |