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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00081926
Recruitment Status : Completed
First Posted : April 29, 2004
Last Update Posted : November 23, 2009
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE April 26, 2004
First Posted Date  ICMJE April 29, 2004
Last Update Posted Date November 23, 2009
Study Start Date  ICMJE October 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Official Title  ICMJE Not Provided
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Myelogenous Leukemia
Intervention  ICMJE Drug: Gleevec
Study Arms  ICMJE Not Provided
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. doi: 10.1200/JCO.2008.20.3869. 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
 (submitted: June¬†23,¬†2005)
112
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00081926
Other Study ID Numbers  ICMJE CSTI571AUS177
US177
RIGHT Trial
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP