Trials / Completed
CompletedNCT01216085
An Exploratory Study of High-dose Glivec in Patients With CML-CP Using Molecular Endpoints
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | high-dose imatinib | Study patients will receive 400 mg twice daily oral administration in the morning and the evening. |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2010-10-07
- Last updated
- 2021-03-10
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01216085. Inclusion in this directory is not an endorsement.