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OpenTrials
Completed

NCT Number: NCT01216085

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

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.

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Key information

Conditions

CML Imatinib

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigational Site

Seoul, 01008, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high-dose imatinib

Drug

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

Primary outcomes

  1. Major molecular response

    Time frame: 60 months

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

Secondary outcomes

  1. progression-free survival

    Time frame: 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

    Time frame: until 60 months

    compliance status and adverse events

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: CML

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 7, 2010
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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