Status:
COMPLETED
Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the molecular response to high dose Gleevec in newly diagnosed patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase. This study will evaluate the ability of Gleev...
Eligibility Criteria
Inclusion
- Participants must meet all of the following criteria:
- Male or Female patients 18 years and older.
- Patient with a diagnosis of chronic myelogenous leukemia in chronic phase
- Within 6 months of initial diagnosis.
- Received any treatment for CML for less than 1 month prior to study entry with the exception of hydroxyurea and/or anagrelide.
Exclusion
- Late chronic phase, accelerated phase or blastic phase
- Taking any other investigational agents within 28 days of starting the study
- If sibling donors have been identified and where allogeneic bone marrow transplantation will be the first line treatment.
- Another primary malignancy /cancer unless it is not considered clinically significant or does not require active intervention.
- If patients have heart problems or complications
- Pregnant or breast-feeding females
- Severe and/or uncontrolled disease such as diabetes, chronic renal disease, etc.
- Chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- Diagnosis of human immunodeficiency virus (HIV) infection.
- Received any treatment for CML for longer than 1 month prior to study entry with the exception of hydroxyurea and/or anagrelide.
- Patient previously received radiotherapy to greater than 25% of the bone marrow.
- Patient had a major surgery within 4 weeks prior to study entry
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00081926
Start Date
October 1 2003
End Date
March 1 2007
Last Update
November 23 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis RIGHT Trial Hotline
East Hanover, New Jersey, United States