Clinical trial NCT02389972: Effectiveness of Dasatinib in Adult Patients With Chronic Myeloid Leukemia in China: A Multicenter, Registry Study
Official title: Effectiveness of Dasatinib(Sprycel®) in Adult Patients With Chronic Myeloid Leukemia in China: A Multicenter, Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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)

Eligibility 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

Primary outcomes:
measure: Rate of Hematologic response (HR) for Chronic phase (CP), Advanced phase (AP),Blast phase (BP)
timeFrame: Upto 2 years
measure: Rate of Cytogenetic response (CR) for Chronic phase, Advanced phase,Blast phase
timeFrame: Upto 2 years
measure: Rate of Molecular response (MR) for Chronic phase,Advanced phase,Blast phase
timeFrame: Upto 2 years
Secondary outcomes:
measure: Demographic and baseline characteristics of patients using dasatinib including health insurance, concomitant regimens, risk scores, and comorbidities based on patient-reported questionnaire
timeFrame: Upto 2 years
measure: Dasatinib treatment pattern, including medication adherence and treatment interruption based on patient-reported questionnaire
timeFrame: Upto 2 years
measure: Relationship between time to initiation of dasatinib after imatinib failure and best response to dasatinib
timeFrame: Upto 2 years
measure: Progression-free survival (PFS)
timeFrame: Upto 2 years
measure: Overall survival (OS)
timeFrame: Upto 2 years
measure: Safety of dasatinib measured by incidence and severity of adverse events
timeFrame: Upto 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Local Institution
state: Hubei
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: