This trial is active, not recruiting.

Condition leukemia, myelogenous, chronic, bcr-abl positive
Treatment dasatinib
Target BCR-ABL
Sponsor Bristol-Myers Squibb
Start date April 2013
End date April 2017
Trial size 300 participants
Trial identifier NCT02389972, CA180-518


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Cohort of chronic myeloid leukemia patients treated with second-line dasatinib (Sprycel)
dasatinib Sprycel

Primary Outcomes

Rate of Hematologic response (HR) for Chronic phase (CP), Advanced phase (AP),Blast phase (BP)
time frame: Upto 2 years
Rate of Cytogenetic response (CR) for Chronic phase, Advanced phase,Blast phase
time frame: Upto 2 years
Rate of Molecular response (MR) for Chronic phase,Advanced phase,Blast phase
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
time frame: Upto 2 years
Dasatinib treatment pattern, including medication adherence and treatment interruption based on patient-reported questionnaire
time frame: Upto 2 years
Relationship between time to initiation of dasatinib after imatinib failure and best response to dasatinib
time frame: Upto 2 years
Progression-free survival (PFS)
time frame: Upto 2 years
Overall survival (OS)
time frame: Upto 2 years
Safety of dasatinib measured by incidence and severity of adverse events
time frame: Upto 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effectiveness of Dasatinib(Sprycel®) in Adult Patients With Chronic Myeloid Leukemia in China: A Multicenter, Registry Study
Description Breakpoint cluster region (BCR) Abelson murine leukemia viral oncogene homolog 1 (c-ABL) Chronic myeloid leukemia (CML)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.