Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00081926

First received: April 26, 2004

Last updated: November 20, 2009

Last verified: November 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	April 26, 2004
Last Updated Date	November 20, 2009
Start Date ^ICMJE	October 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00081926 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Official Title ^ICMJE
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 Gleevec to reduce the amount of abnormal protein that occurs in patients with CML. Patients who are eligible to participate will be treated for 18 months. This trial will include male or female patients 18 years or older who are newly diagnosed (within 6 months) with CML.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Myelogenous Leukemia
Intervention ^ICMJE	Drug: Gleevec
Study Arm (s)
Publications *	Cortes JE, Kantarjian HM, Goldberg SL, Powell BL, Giles FJ, Wetzler M, Akard L, Burke JM, Kerr R, Saleh M, Salvado A, McDougall K, Albitar M, Radich J; Rationale and Insight for Gleevec High-Dose Therapy (RIGHT) Trial Study Group. High-dose imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: high rates of rapid cytogenetic and molecular responses. J Clin Oncol. 2009 Oct 1;27(28):4754-9. Epub 2009 Aug 31.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	112
Completion Date	March 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Criteria: 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00081926
Other Study ID Numbers ^ICMJE	CSTI571AUS177, US177, RIGHT Trial
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Novartis Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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