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

Leukemia, Myelogenous, Chronic, BCR-ABL Positive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389972
• Other study ID #: CA180-518
• Status: Completed
• Phase: N/A
• First received: October 29, 2014
• Last updated: September 8, 2017
• Start date: April 11, 2013
• Est. completion date: July 13, 2017

Study information

• Verified date: September 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Breakpoint cluster region (BCR)

Abelson murine leukemia viral oncogene homolog 1 (c-ABL)

Chronic myeloid leukemia (CML)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: July 13, 2017
• Est. primary completion date: July 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Dasatinib

Locations

Country	Name	City	State
China	Local Institution	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	Relationship between time to initiation of dasatinib after imatinib failure and best response to dasatinib		Upto 2 years
Secondary	Progression-free survival (PFS)		Upto 2 years
Secondary	Overall survival (OS)		Upto 2 years
Secondary	Safety of dasatinib measured by incidence and severity of adverse events		Upto 2 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form