Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Stopped early · Phase 3

Conditions studied: Myelogenous Leukemia

In brief

In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

Key facts

Study ID

NCT00519090

Run by

Novartis Pharmaceuticals

People needed

6

Starts

2007-10-01

Expected to finish

2008-10-01

Last updated by the study team

2011-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.
• Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:
• 6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or
• 12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics, no FISH [fluorescence in situ hybridization] analysis was allowed).

You may not qualify if…

• Patient who have received more than 18 months of imatinib therapy
• Patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.
• Prior treatment with greater than 400 mg/day imatinib.
• Uncontrolled or significant cardiovascular disease.
• Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
• Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
• Currently taking certain medications that could affect the rhythm of your heart.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Southern California Permanente Medical Group — Anaheim, California, United States
• Southern California Permanente Medical Group — Baldwin Park, California, United States
• Southern California Permanente Medical Group — Fontana, California, United States
• Kaiser Permanente Medical Group/Hayward Medical Center — Hayward, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• Kaiser Permanente Medical Group/Oakland Medical Center — Oakland, California, United States
• Southern California Permanente Medical Group — Panorama City, California, United States
• Southern California Permanente Medical Group — Riverside, California, United States
• Kaiser Permanente Medical Group/Sacramento Medical Center — Sacramento, California, United States
• Southern California Permanente Medical Group — San Diego, California, United States
• Kaiser Permanente Medical Group — San Francisco, California, United States
• Kaiser Permanente Medical Group — San Jose, California, United States
• Kaiser Permanente Medical Group/Santa Clara Medical Office — Santa Clara, California, United States
• Kaiser Permanente Medical Group/South San Francisco Medical Center — South San Francisco, California, United States
• Kaiser Permanente Medical Group/Vallejo Medical Center — Vallejo, California, United States
• Kaiser Permanente Medical Group/Walnut Creek Medical Center — Walnut Creek, California, United States
• Southen California Permanente Medical Group — Woodland Hills, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana Blood and Marrow Transplantation — Beech Grove, Indiana, United States
• Holden Cancer Center — Iowa City, Iowa, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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