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

Novartis Pharmaceuticals10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

CML Imatinib

Interventions

high-dose imatinibDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

Major molecular response

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

Time frame: 60 months

Secondary Outcomes

progression-free survival

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.

Time frame: until 60 months

number of adverse events

compliance status and adverse events

Time frame: until 60 months

Data from ClinicalTrials.gov

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