Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Completed · Phase 3

Conditions studied: Chronic Myelogenous Leukemia

In brief

The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.

Key facts

Study ID

NCT00333840

Run by

Novartis Pharmaceuticals

People needed

1106

Starts

2000-06-01

Expected to finish

2012-03-01

Last updated by the study team

2013-10-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have signed consent for Amendment 5
• Must have completed visit 62 of the core IRIS trial or be in follow-up
• Must be on STI571 treatment
• If on IFN treatment, must be willing to cross over to STI571 treatment

You may not qualify if…

• Patients who have discontinued from the study and are in follow-up
• Patients who are on IFN treatment and do not want to cross over to STI571 treatment
• Patients who have not consented to amendment 5
• Patients who did not complete the amendment 5 protocol
• Additional protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Montgomery, Alabama, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Berkeley, California, United States
• Novartis Investigative Site — Campbell, California, United States
• Novartis Investigative Site — Duarte, California, United States
• Novartis Investigative Site — La Jolla, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Honolulu, Hawaii, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Decatur, Illinois, United States
• Novartis Investigative Site — Beech Grove, Indiana, United States
• Novartis Investigative Site — Witchita, Kansas, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — New Orleans, Louisiana, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Worcester, Massachusetts, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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