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Phase 4
18 Years
N/A
Not Enrolling
Both
Chronic Myelogenous Leukemia

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Trial Information


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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

CSTI571AUS177

NCT ID:

NCT00081926

Start Date:

October 2003

Completion Date:

March 2007

Related Keywords:

  • Chronic Myelogenous Leukemia
  • CML
  • Chronic Myelogenous Leukemia
  • RIGHT Trial
  • US177
  • CSTI571
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

Name

Location

Novartis RIGHT Trial HotlineEast Hanover, New Jersey