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

Effectiveness of Dasatinib(Sprycel®) 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.

Study Overview

• Status: Completed
• Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Intervention / Treatment: Drug: Dasatinib

Detailed Description

Breakpoint cluster region (BCR)

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

Chronic myeloid leukemia (CML)

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients must be naive to dasatinib before the enrollment period, be over the age of 18 years with a confirmed diagnosis of any phase CML by the treating physician, and are to initiate treatment with dasatinib based on the physician's clinical judgement

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CML patients treated with dasatinib; Cohort of chronic myeloid leukemia patients treated with second-line dasatinib (Sprycel)	Drug: Dasatinib; Other Names: Sprycel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic and baseline characteristics of patients using dasatinib including health insurance, concomitant regimens, risk scores, and comorbidities based on patient-reported questionnaire	Type and percentage of each variable: health insurance, concomitant regimens and comorbidities; patients distribution by Sokal score	Upto 2 years
Dasatinib treatment pattern, including medication adherence and treatment interruption based on patient-reported questionnaire	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	Upto 2 years
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2013
• Primary Completion (Actual): July 13, 2017
• Study Completion (Actual): July 13, 2017

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Dasatinib
• Other Study ID Numbers: CA180-518