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

NCT02389972 | Completed

• 1 other identifier: CA180-518
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

• Dasatinib treatment pattern, including medication adherence and treatment interruption based on patient-reported questionnaire

  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

Study Arms (1)

CML patients treated with dasatinib

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

Drug: Dasatinib

Interventions

Dasatinib DRUG

Also known as: Sprycel

CML patients treated with dasatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- Patients participating in clinical trials for CML that explicitly prohibit recruitment in additional studies

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Wuhan, Hubei, 430022, China

Location

Related Links

• Investigator Inquiry Form

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: March 17, 2015
• Study Start: April 11, 2013
• Primary Completion: July 13, 2017
• Study Completion: July 13, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

CN (1)