Skip to main content
OpenTrials
Completed

NCT Number: NCT03509896

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

Observational medical record review of newly diagnosed CML-CP participants in China

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Tianjin, Tianjin Municipality, 300020, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2018
Registry last updated
Jun 27, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.