Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Conditions
Brief summary
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
Breakpoint cluster region (BCR) Abelson murine leukemia viral oncogene homolog 1 (c-ABL) Chronic myeloid leukemia (CML)
Interventions
DRUGDasatinib
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Hematologic response (HR) for Chronic phase (CP), Advanced phase (AP),Blast phase (BP) | Upto 2 years | 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 |
| Rate of Cytogenetic response (CR) for Chronic phase, Advanced phase,Blast phase | Upto 2 years | Cytogenetic Response is a response to treatment of CML that occurs in the marrow, rather than just in the blood |
| Rate of Molecular response (MR) for Chronic phase,Advanced phase,Blast phase | Upto 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Upto 2 years | — |
| Demographic and baseline characteristics of patients using dasatinib including health insurance, concomitant regimens, risk scores, and comorbidities based on patient-reported questionnaire | Upto 2 years | Type and percentage of each variable: health insurance, concomitant regimens and comorbidities; patients distribution by Sokal score |
| Safety of dasatinib measured by incidence and severity of adverse events | Upto 2 years | — |
| Overall survival (OS) | Upto 2 years | — |
| Dasatinib treatment pattern, including medication adherence and treatment interruption based on patient-reported questionnaire | Upto 2 years | 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 |
| Relationship between time to initiation of dasatinib after imatinib failure and best response to dasatinib | Upto 2 years | — |
Countries
China
Outcome results
None listed