Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

Completed · Phase 3

Conditions studied: Chronic Myeloid Leukemia

In brief

Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

Key facts

Study ID

NCT00574873

Run by

Pfizer

People needed

502

Starts

2008-02-05

Expected to finish

2015-05-27

Last updated by the study team

2019-01-08

Who can join

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

You may qualify if…

• Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.
• Diagnosis of CML chronic phase confirmed.
• Adequate hepatic and renal function.
• Able to take oral tablets.

You may not qualify if…

• Exclusions include Philadelphia negative CML.
• Prior anti-leukemia treatment.
• Prior stem cell transplant.

Where it is running

• Tower Cancer Research Foundation (TCRF) — Beverly Hills, California, United States
• Robert A Moss, MD, FACP, Inc — Fountain Valley, California, United States
• UCSD Medical Center-Thornton — La Jolla, California, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• UCSD Medical Center-Hillcrest — San Diego, California, United States
• Stanford Hospital and Clinics Investigational Drug Services — Stanford, California, United States
• Stanford Hospitals and Clinics — Stanford, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Cancer Care Centers of Florida — Hudson, Florida, United States
• Cancer Care Centers of Florida — New Port Richey, Florida, United States
• Pasco Pinellas Cancer Center — New Port Richey, Florida, United States
• Orlando Health, Inc. — Orlando, Florida, United States
• Pasco Pinellas Cancer Center — Tarpon Springs, Florida, United States
• Northside Hospital, Inc. - GCS/Annex — Atlanta, Georgia, United States
• Indiana Blood and Marrow Transplantation Research Franciscan St. Francis Health Center Inc. — Indianapolis, Indiana, United States
• Indiana Blood and Marrow Transplantation Research — Indianapolis, Indiana, United States
• Siouxland Hematology-Oncology Associates, LLP — Sioux City, Iowa, United States
• Cancer Center of Kansas — Salinas, Kansas, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Kentucky Cancer Clinic — Hazard, Kentucky, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Josephine Ford Cancer - Downriver — Brownstown, Michigan, United States
• Henry Ford Medical Center- Fairlane — Dearborn, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Pacific Cancer Medical Center Inc — Anaheim, California, United States

Full record on ClinicalTrials.gov

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