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

Novartis Pharmaceuticals (Industry)
Overall Status
Completed ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: high-dose imatinib
Phase 2

Study Design

Study Type:
Actual Enrollment :
10 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
An Exploratory Single Center Study of High-dose Treatment of GlivecĀ® 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
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: imatinib

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

Drug: high-dose imatinib
Study patients will receive 400 mg twice daily oral administration in the morning and the evening.

Outcome Measures

Primary Outcome Measures

  1. Major molecular response [60 months]

    Major molecular response achieved to Month 60 from the time of Glivec treatment

Secondary Outcome Measures

  1. 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.

  2. number of adverse events [until 60 months]

    compliance status and adverse events

Eligibility Criteria


Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Accepts 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

Contacts and Locations


Site City State Country Postal Code
1 Novartis Investigational Site Seoul Korea, Republic of 01008

Sponsors and Collaborators

  • Novartis Pharmaceuticals


  • Principal Investigator: Dong-Wook Kim, MD, PhD, Catholic Medical Center

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Novartis Pharmaceuticals Identifier:
Other Study ID Numbers:
  • CSTI571AKR23
First Posted:
Oct 7, 2010
Last Update Posted:
Mar 10, 2021
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2021