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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01216085
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 11
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
CML; Imatinib	Drug: high-dose imatinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: imatinib Study patients will receive 400 mg twice daily oral administration in the morning and the evening.	Drug: high-dose imatinib; Study patients will receive 400 mg twice daily oral administration in the morning and the evening.

Outcome Measures

Primary Outcome Measures

1. Major molecular response [60 months]

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

Secondary Outcome Measures

1. progression-free survival [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 [until 60 months]

   compliance status and adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigational Site	Seoul		Korea, Republic of	01008

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Principal Investigator: Dong-Wook Kim, MD, PhD, Catholic Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01216085
• Other Study ID Numbers: CSTI571AKR23
• First Posted: Oct 7, 2010
• Last Update Posted: Mar 10, 2021
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: Imatinib Mesylate

Study Results

No Results Posted as of Mar 10, 2021