An Exploratory Study of High-dose Glivec in Patients With CML-CP Using Molecular Endpoints

An Exploratory Single Center Study of High-dose Treatment of Glivec® in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity) Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01216085

Acronym

CML

Enrollment

Registered

2010-10-07

Start date

2010-08-31

Completion date

2011-07-31

Last updated

2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CML, Imatinib

Brief summary

This study is locally amended study from CSTI571K2301 to evaluate the efficacy and safety of high-dose Glivec in Korean patients group with chronic phase of CML. Molecular response at 60 months after Glivec administration will be described.

Interventions

DRUGhigh-dose imatinib

Study patients will receive 400 mg twice daily oral administration in the morning and the evening.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. TOPS(CSTI571K2301) participant patients who are taking Glivec more than 400 mg daily as 30 July, 2010, the close date of TOPS 2. Patients who provided written informed consent prior to participation to this study

Design outcomes

Primary

Measure	Time frame	Description
Major molecular response	60 months	Major molecular response achieved to Month 60 from the time of Glivec treatment

Secondary

Measure	Time frame	Description
progression-free survival	until 60 months	Besides Complete molecular response, complete and major cytogenetic response achieved, event-free survival, and survival without progression to AP/BC achieved to Month 60 from the time of Glivec treatment, Progression-free survival will be evaluated.
number of adverse events	until 60 months	compliance status and adverse events

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026