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

NCT ID: NCT02389972

Last Updated: 2017-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-11

Study Completion Date

2017-07-13

Brief Summary

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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

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Breakpoint cluster region (BCR)

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

Chronic myeloid leukemia (CML)

Conditions

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Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CML patients treated with dasatinib

Cohort of chronic myeloid leukemia patients treated with second-line dasatinib (Sprycel)

Dasatinib

Intervention Type DRUG

Interventions

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Dasatinib

Intervention Type DRUG

Other Intervention Names

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Sprycel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Wuhan, Hubei, China

Site Status

Countries

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China

Related Links

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Other Identifiers

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CA180-518

Identifier Type: -

Identifier Source: org_study_id

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