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

Novartis

Status and phase: Completed; Phase 2

Conditions: Imatinib; CML

Treatments: Drug: high-dose imatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01216085

CSTI571AKR23

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

imatinib

Experimental group

Description:

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

Treatment:

Drug: high-dose imatinib