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

Completed

• Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Interventions: Drug: Dasatinib

• Registration Number: NCT02389972
• Lead Sponsor: Bristol-Myers Squibb

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)

Study Timeline

• Study Start: 2013-04-11
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-17
• Primary Completion: 2017-07-13
• Study Completion: 2017-07-13
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CML patients treated with dasatinib	Dasatinib	Cohort of chronic myeloid leukemia patients treated with second-line dasatinib (Sprycel)

Primary Outcome Measures

Name	Time	Method
Rate of Hematologic response (HR) for Chronic phase (CP), Advanced phase (AP),Blast phase (BP)	Upto 2 years	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
Rate of Molecular response (MR) for Chronic phase,Advanced phase,Blast phase	Upto 2 years	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
Rate of Cytogenetic response (CR) for Chronic phase, Advanced phase,Blast phase	Upto 2 years	Cytogenetic Response is a response to treatment of CML that occurs in the marrow, rather than just in the blood

Secondary Outcome Measures

Name	Time	Method
Demographic and baseline characteristics of patients using dasatinib including health insurance, concomitant regimens, risk scores, and comorbidities based on patient-reported questionnaire	Upto 2 years	Type and percentage of each variable: health insurance, concomitant regimens and comorbidities; patients distribution by Sokal score
Dasatinib treatment pattern, including medication adherence and treatment interruption based on patient-reported questionnaire	Upto 2 years	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
Relationship between time to initiation of dasatinib after imatinib failure and best response to dasatinib	Upto 2 years
Progression-free survival (PFS)	Upto 2 years
Overall survival (OS)	Upto 2 years
Safety of dasatinib measured by incidence and severity of adverse events	Upto 2 years

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Wuhan, Hubei, China