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
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00081926     History of Changes
Other Study ID Numbers: CSTI571AUS177, US177, RIGHT Trial
Study First Received: April 26, 2004
Last Updated: November 20, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014