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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.
Breakpoint cluster region (BCR)
Abelson murine leukemia viral oncogene homolog 1 (c-ABL)
Chronic myeloid leukemia (CML)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CML patients treated with dasatinib | Cohort of chronic myeloid leukemia patients treated with second-line dasatinib (Sprycel) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug |
|
|
| 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 |
| 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 |
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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:
Exclusion Criteria:
- Patients participating in clinical trials for CML that explicitly prohibit recruitment in additional studies
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Patients must be naive to dasatinib before the enrollment period, be over the age of 18 years with a confirmed diagnosis of any phase CML by the treating physician, and are to initiate treatment with dasatinib based on the physician's clinical judgement
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Wuhan | Hubei | 430022 | China |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| 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 |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |