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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Novartis Korea Ltd.

ClinicalTrials.gov Identifier:

NCT01216085

First received: September 27, 2010

Last updated: October 5, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2010

Last Updated Date

October 5, 2010

Start Date ^ICMJE

August 2010

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Major molecular response [ Time Frame: 60 months ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01216085 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

progression-free survival [ Time Frame: until 60 months ] [ Designated as safety issue: No ]
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 [ Time Frame: until 60 months ] [ Designated as safety issue: Yes ]
compliance status and adverse events

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

CML
Imatinib

Intervention ^ICMJE

Drug: high-dose imatinib

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

Study Arm (s)

Experimental: imatinib

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

Intervention: Drug: high-dose imatinib

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01216085

Other Study ID Numbers ^ICMJE

CSTI571AKR23

Has Data Monitoring Committee

Responsible Party

Hijung Cho, Medical advisor, Oncology, Novartis Korea, Ltd.

Study Sponsor ^ICMJE

Novartis Korea Ltd.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dong-Wook Kim, MD, PhD

Catholic Medical Center

Information Provided By

Novartis Korea Ltd.

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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