A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Completed · Phase 3

Conditions studied: Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive

In brief

Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

Key facts

Study ID

NCT02130557

Run by

Pfizer

People needed

536

Starts

2014-07-15

Expected to finish

2020-04-17

Last updated by the study team

2021-05-18

Who can join

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

You may qualify if…

• Molecular diagnosis of CP CML of ≤ 6 months (from initial diagnosis).
• Adequate hepatic, renal and pancreatic function.
• Age ≥ 18 years.

You may not qualify if…

• Any prior medical treatment for CML, including tyrosine kinase inhibitors (TKIs), with the exception of hydroxyurea and/or anagrelide treatment, which are permitted for up to 6 months prior to study entry (signature of ICF) if suitably approved for use in the subject's region.
• Any past or current Central Nervous System (CNS) involvement, including leptomeningeal leukemia.
• Extramedullary disease only.
• Major surgery or radiotherapy within 14 days of randomization.
• History of clinically significant or uncontrolled cardiac disease.
• Known seropositivity to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface-antigen positive), hepatitis C, cirrhosis or evidence of decompensated liver disease. Patients with resolved Hepatitis B can be included.
• Recent or ongoing clinically significant GI disorder, e.g. Crohn's Disease, Ulcerative Colitis, or prior total or partial gastrectomy.
• History of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.
• Current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Kaiser Permanente Hawaii — Honolulu, Hawaii, United States
• Saint Alphonsus Regional Medical Center, Cancer Care Center — Boise, Idaho, United States
• Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
• Saint Alphonsus Caldwell Cancer Care Center — Caldwell, Idaho, United States
• Saint Alphonsus Medical Center Nampa — Nampa, Idaho, United States
• University of Illinois Cancer Center — Chicago, Illinois, United States
• John H. Stroger, Jr. Hospital of Cook County — Chicago, Illinois, United States
• Indiana Blood and Marrow Transplantation — Indianapolis, Indiana, United States
• PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D — Indianapolis, Indiana, United States
• Cancer Center of Acadiana at Lafayette General Medical Center — Lafayette, Louisiana, United States
• Lafayette General Medical Center — Lafayette, Louisiana, United States
• LSU Health Sciences Center-Shreveport — Shreveport, Louisiana, United States
• University Health Shreveport — Shreveport, Louisiana, United States
• Rcca Md Llc — Bethesda, Maryland, United States
• University of Massachusetts Memorial Medical Center, ONC/Research Pharmacy — Worcester, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• St. Joseph Mercy Hospital - Inpatient Pharmacy — Ann Arbor, Michigan, United States
• St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• St. Joseph Mercy-Brighton — Brighton, Michigan, United States
• St. Joseph Mercy-Canton — Canton, Michigan, United States
• Chelsea Community Hospital — Chelsea, Michigan, United States
• Pacific Cancer Medical Center, Inc. — Anaheim, California, United States

Full record on ClinicalTrials.gov

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