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

Bristol-Myers Squibb128 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

128

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

DasatinibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Wuhan, Hubei, China

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Upto 2 years

Secondary Outcomes

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

Time frame: 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

Time frame: Upto 2 years

Data from ClinicalTrials.gov

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