NCT03509896

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
463

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2019

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

April 18, 2018

Last Update Submit

June 21, 2022

Conditions

Chronic Myeloid LeukemiaPhiladelphia ChromosomeChronic Myeloid Leukemia in Chronic Phase

Outcome Measures

Primary Outcomes (5)

  • Number of participants receiving each first-line treatment option

    2 years

  • Number of participants with complete cytogenetic response

    Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow (BM)

    2 years

  • Number of participants with major molecular response (MMR)

    Major molecular response (MMR) is defined as 3-log reduction in International Scale of BCR-ABL mRNA

    2 years

  • Number of participants of each initial dose schema

    2 years

  • Starting dose of each first-line agent

    2 years

Secondary Outcomes (2)

  • Distribution of demographic characteristics

    2 years

  • Distribution of clinical characteristics

    2 years

Study Arms (1)

Participants newly diagnosed with CML-CP

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

Participants newly diagnosed with CML-CP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Multi-center, observational, medical record review of approximately 1000 newly diagnosed CML-CP patients in China

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Tianjin, Tianjin Municipality, 300020, China

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositivePhiladelphia Chromosome

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsTranslocation, GeneticChromosome Aberrations

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2018

First Posted

April 26, 2018

Study Start

November 30, 2017

Primary Completion

June 7, 2019

Study Completion

September 28, 2019

Last Updated

June 27, 2022

Record last verified: 2022-06

Locations

CN(1)