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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-07-31

Brief Summary

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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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Detailed Description

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Conditions

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CML Imatinib

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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imatinib

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

Group Type EXPERIMENTAL

high-dose imatinib

Intervention Type DRUG

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

Interventions

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high-dose imatinib

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No