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

CML Clinical Trial

— CML  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216085
• Other study ID #: CSTI571AKR23
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: July 2011

Study information

• Verified date: October 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• CML
• Imatinib

Intervention

Drug:
• high-dose imatinib
Study patients will receive 400 mg twice daily oral administration in the morning and the evening.

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major molecular response	Major molecular response achieved to Month 60 from the time of Glivec treatment	60 months
Secondary	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.	until 60 months
Secondary	number of adverse events	compliance status and adverse events	until 60 months