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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Treatments: Drug: Dasatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT02389972

CA180-518

Details and patient eligibility

About

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

Full description

Breakpoint cluster region (BCR)

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

Chronic myeloid leukemia (CML)

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

128 participants in 1 patient group

CML patients treated with dasatinib

Description:

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

Treatment:

Drug: Dasatinib