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Study of Chinese Newly Diagnosed Participants With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03509896
Recruitment Status : Unknown
Verified April 2018 by Bristol-Myers Squibb.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
Observational medical record review of newly diagnosed CML-CP participants in China

Condition or disease Intervention/treatment
Chronic Myeloid Leukemia Philadelphia Chromosome Chronic Myeloid Leukemia in Chronic Phase Other: Non-Interventional

Study Design
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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Pattern, Clinical Outcome and Healthcare Resource Utilization Associated With Chinese Newly Diagnosed Patients With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP): A Retrospective Observational Study
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Participants newly diagnosed with CML-CP Other: Non-Interventional
Non-Interventional


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants receiving each first-line treatment option [ Time Frame: 2 years ]
  2. Number of participants with complete cytogenetic response [ Time Frame: 2 years ]
    Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow (BM)

  3. Number of participants with major molecular response (MMR) [ Time Frame: 2 years ]
    Major molecular response (MMR) is defined as 3-log reduction in International Scale of BCR-ABL mRNA

  4. Number of participants of each initial dose schema [ Time Frame: 2 years ]
  5. Starting dose of each first-line agent [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Distribution of demographic characteristics [ Time Frame: 2 years ]
    Including age, sex, height, weight

  2. Distribution of clinical characteristics [ Time Frame: 2 years ]
    Including health insurance and comorbid conditions


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Multi-center, observational, medical record review of approximately 1000 newly diagnosed CML-CP patients in China
Criteria

Inclusion Criteria:

  • Ph+ CML-CP patients who were diagnosed between August 1, 2014 to August 1, 2016
  • 18 years or older at time of diagnosis

Exclusion Criteria:

  • Participants once enrolled in any interventional clinical trial for CML
  • Participants whose records are not available

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509896


Locations
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China, Tianjin
Local Institution
Tianjin, Tianjin, China, 300020
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03509896    
Other Study ID Numbers: CA180-681
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
 Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes