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Completed

NCT Number: NCT02389972

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

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

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Key information

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Wuhan, Hubei, 430022, China

About this study

Breakpoint cluster region (BCR)

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

Chronic myeloid leukemia (CML)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dasatinib

Drug

Other names: Sprycel

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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

  2. 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

  3. Relationship between time to initiation of dasatinib after imatinib failure and best response to dasatinib

    Time frame: Upto 2 years

  4. Progression-free survival (PFS)

    Time frame: Upto 2 years

  5. Overall survival (OS)

    Time frame: Upto 2 years

  6. Safety of dasatinib measured by incidence and severity of adverse events

    Time frame: Upto 2 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2015
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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