Chronic Myelod Leukemia Registry at Asan Medical Center

Terminated

• Conditions: Myeloid Leukemia, Chronic, Accelerated Phase; Leukemia, Chronic Myeloid; Myeloid Leukemia, Chronic, Chronic Phase
• Interventions: Other: Diagnosed as CML

• Registration Number: NCT01761695
• Lead Sponsor: Asan Medical Center

Brief Summary

The investigators would like to propose a prospective longitudinal observational cohort study for patients who will be diagnosed and/or treated for chronic myeloid leukemia at Asan Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other retrospective analysis.

Detailed Description

1. Acquisition of informed concent form

2. Data acquisition from medical record including

* demographic / disease-associated factors

* details of treatment, and its results

* complications during treatment

* genetic data

* survival outcome (upto 30 years)

3. Accumulation of data for 30 years

4. Use of data for other retrospective analysis (including Asan Medical center Cell Banking basic data)

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-07
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients who are diagnosed and/or treated as chronic myeloid leukemia at Asan Medical Center
• 15 years of age and over
• All patients who give written consent according to guidelines at Asan Medical Center committee on human research

Exclusion Criteria

• Patients who refuse to give consent to registering

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CML CP	Diagnosed as CML	Diagnosed as CML with chronic phase
CML AP	Diagnosed as CML	Diagnosed as CML with accelerated phase
CML BC	Diagnosed as CML	Diagnosed as CML with blast crisis
CML other	Diagnosed as CML	Diagnosed as CML, which is not included in any of other category

Primary Outcome Measures

Name	Time	Method
Overall survival	30 years

Secondary Outcome Measures

Name	Time	Method
Event-free survival	30 years	Definition of events will be as 'failure', 'progress to AP/BC', 'intolerant and medication change', and 'death from any cause'.
Failure-free survival	30 years	Failure will be defined as BCR-ABL elevation at 2 serial times, progression to AP/BC, loss of hematologic / cytogenetic response, any appearance of ABL kinase mutation, and clonal evolution.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of