Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting

Completed

Conditions studied: Chronic Myeloid Leukemia

In brief

The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.

Key facts

Study ID

NCT01244750

Run by

Bristol-Myers Squibb

People needed

1494

Starts

2010-12-02

Expected to finish

2020-01-08

Last updated by the study team

2022-06-30

Who can join

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

You may qualify if…

• Newly-diagnosed chronic phase chronic myeloid leukemia (CP-CML) patients who started their first-line Tyrosine Kinase Inhibitor (TKI) treatment on imatinib, dasatinib or nilotinib in accordance with the timelines below
• 18 years or older at time of of CP-CML diagnosis
• a) Imatinib Cohorts
• Patients who started their first-line Imatinib treatment between January 2, 2008 and September 30, 2010.Patients fitting this criterion are defined as retrospective Imatinib patients
• Patients who started their first-line Imatinib treatment on or after October 1, 2010
• b) Dasatinib Cohort
• Patients who started their first-line Dasatinib treatment after the drug was approved in this indication
• c) Nilotinib Cohort
• Patients who started their first-line Nilotinib treatment after the drug was approved in this indication
• Patients are also eligible when they have already switched to a subsequent therapy (TKI or other) at the time of enrollment, as long as their first-line and subsequent CML treatment information is available at site for data entry into the study Electronic Case Report Form (eCRF)
• Receiving treatment at medical practice (eg. community-based, office-based, hospital-based, academic setting, oncology center)

You may not qualify if…

• Patients who are participating in an interventional trial which may influence the management of their CML disease will be excluded
• Discontinuation Criteria:
• Enrolled patients who join an interventional trial which may influence the management of their CML disease will be excluded at the time of entry into the interventional trial

Where it is running

• Arizona Oncology Associates, PC - HAL — Phoenix, Arizona, United States
• Arizona Oncology Associates, PC - NAHOA — Sedona, Arizona, United States
• Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
• Genesis Cancer Center — Hot Springs, Arkansas, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Little Rock Hematology Oncology Associates — Little Rock, Arkansas, United States
• Pacific Cancer Medical Center, Inc — Anaheim, California, United States
• Southwest Cancer Care Medical Group — Escondido, California, United States
• Wilshire Oncology Medical Group, Inc — Glendora, California, United States
• University of Southern California — Los Angeles, California, United States
• St. Joseph's Hospital — Orange, California, United States
• PMK Medical Group, Inc. DBA Ventura — Oxnard, California, United States
• Stockton Hematology Oncology — Stockton, California, United States
• Tahoe Forest Health System Cancer Center — Truckee, California, United States
• Rocky Mountain Cancer Centers — Boulder, Colorado, United States
• Medical Oncology and Blood Disorders, LLP — Manchester, Connecticut, United States
• Stamford Hospital — Stamford, Connecticut, United States
• Washington Hospital Center, Washington Cancer Institute — Washington D.C., District of Columbia, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Hematology And Medical Oncology Of Southern Palm Beach County — Boynton Beach, Florida, United States
• Broward Oncology Associates — Fort Lauderdale, Florida, United States
• Palm Springs Research Institute — Hialeah, Florida, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• University Of Florida — Jacksonville, Florida, United States
• Northwest Alabama Cancer Center — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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