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Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
This study has been completed.
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00081926
  Purpose

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.


Condition Intervention Phase
Chronic Myelogenous Leukemia
Drug: Gleevec
Phase IV

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Imatinib Imatinib mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Novartis:

Estimated Enrollment: 112
Study Start Date: October 2003
Estimated Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081926

Locations
United States, New Jersey
Novartis RIGHT Trial Hotline
East Hanover, New Jersey, United States
Sponsors and Collaborators
Novartis
  More Information

Novartis Clinical Trials Listing  This link exits the ClinicalTrials.gov site

Study ID Numbers: CSTI571AUS177, US177, RIGHT Trial
Study First Received: April 26, 2004
Last Updated: June 4, 2008
ClinicalTrials.gov Identifier: NCT00081926  
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
CML
Chronic Myelogenous Leukemia
RIGHT Trial
US177
CSTI571

Study placed in the following topic categories:
Imatinib
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009