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

Overview

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

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 13, 2017

Detailed Description

Breakpoint cluster region (BCR) Abelson murine leukemia viral oncogene homolog 1 (c-ABL) Chronic myeloid leukemia (CML)

Interventions

  • Drug: Dasatinib

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Demographic and baseline characteristics of patients using dasatinib including health insurance, concomitant regimens, risk scores, and comorbidities based on patient-reported questionnaire
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Upto 2 years
  • Progression-free survival (PFS)
    • Time Frame: Upto 2 years
  • Overall survival (OS)
    • Time Frame: Upto 2 years
  • Safety of dasatinib measured by incidence and severity of adverse events
    • Time Frame: Upto 2 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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