Studying First Line Treatment of Chronic Myeloid Leukemia (CML) in a Real-world Setting
- Conditions
- Chronic Myeloid Leukemia
- Registration Number
- NCT01244750
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Time Perspective : Most patients are expected to be a mix of retrospective and prospective data collection. Patients can be enrolled after their study index date (retrospective component) and have to be followed until 5 years from study index date are complete (time between enrollment and 5 year follow-up is the prospective component)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1494
-
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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response) Every 6 months for a follow-up period of 5-years from study index date Results and dates of: all bone marrow aspirates, blood tests, cytogenetics, Polymerase Chain Reaction (PCR), Fluorescent In-Situ Hybridization (FISH), and Physical exam
The rate of discontinuation and treatment changes after initial TKI treatment Every 6 months for a follow-up period of 5-years from study index date Dates of switches in therapy from initial TKI treatment, Reasons for treatment discontinuation (i.e. side effects, mutations, etc.), Subsequent lines of CML treatments (start and stop dates)
The duration of initial TKI treatment 5-years from study index date Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)
The rate of Complete Cytogenetic Response 12 months The adherence to treatment Every 6 months for a follow-up period of 5-years from study index date Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.
- Secondary Outcome Measures
Name Time Method Impact of first-line treatment options on quality of life Every 6 months Questionnaires used for assessment:
Functional Assessment of Cancer Therapy - General (FACT-G), Cancer Therapy Satisfaction Questionnaire (CTSQ), MD Anderson Symptom Inventory - CML (MDASI-CML).Resource utilization associated with CML management Every 6 months To evaluate healthcare resource utilization, descriptive statistics will describe real-world disease monitoring patterns, frequency of testing, and resources used for disease management for each treatment cohort.
Non-hematologic side effects from treatment affecting patient quality of life and outcomes Every 6 months Treatment discontinuations and changes
Patient satisfaction with CML treatment Every 6 months Cancer Therapy Satisfaction Questionnaire (CTSQ)
Patterns of disease monitoring as observed in a real-world setting Every 6 months MD Anderson Symptom Inventory - CML (MDASI-CML) Questionnaire - disease-specific module of the MDASI7 which is a brief measure of severity and impact of cancer-related symptoms on daily function
Trial Locations
- Locations (142)
University of Southern California
🇺🇸Los Angeles, California, United States
Peachtree Hematology-Oncology
🇺🇸Atlanta, Georgia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Boston VA Healthcare System
🇺🇸Boston, Massachusetts, United States
Baptist Cancer Center
🇺🇸Miami, Florida, United States
Indiana Blood and Marrow Transplantation
🇺🇸Indianapolis, Indiana, United States
Investigative Clinical Research of Indiana
🇺🇸Indianapolis, Indiana, United States
Cotton O'Neil Cancer Center
🇺🇸Topeka, Kansas, United States
Hutchinson Clinic
🇺🇸Hutchinson, Kansas, United States
Arizona Oncology Associates, PC - NAHOA
🇺🇸Sedona, Arizona, United States
Washington Hospital Center, Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Little Rock Hematology Oncology Associates
🇺🇸Little Rock, Arkansas, United States
Genesis Cancer Center
🇺🇸Hot Springs National Park, Arkansas, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Medical Oncology and Blood Disorders, LLP
🇺🇸Manchester, Connecticut, United States
Rocky Mountain Cancer Centers
🇺🇸Boulder, Colorado, United States
Puerto Rico Hematology Oncology Group
🇵🇷Bayamon, Puerto Rico
Prairie Lakes Healthcare System, Inc
🇺🇸Watertown, South Dakota, United States
Arizona Oncology Associates, PC - HAL
🇺🇸Phoenix, Arizona, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Frederick Memorial Hospital
🇺🇸Frederick, Maryland, United States
Maryland Oncology Hematology Pa
🇺🇸Columbia, Maryland, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Cancer & Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
South Coast Health System
🇺🇸Fall River, Massachusetts, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Consultants In Blood Disorders
🇺🇸Saint Matthews, Kentucky, United States
Commonwealth Hematology-Oncology, P.C.
🇺🇸Quincy, Massachusetts, United States
Willis-Knighton Cancer System
🇺🇸Shreveport, Louisiana, United States
UMass Medical Center
🇺🇸Worcester, Massachusetts, United States
Waverly Hematology Oncology
🇺🇸Cary, North Carolina, United States
Michigan State University
🇺🇸Lansing, Michigan, United States
Hematology-Oncology Associates of Northern NJ, PA
🇺🇸Morristown, New Jersey, United States
Portsmouth Regional Hospital
🇺🇸Portsmouth, New Hampshire, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Advanced Oncology
🇺🇸New York, New York, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
North Mississippi Hematology & Oncology
🇺🇸Tupelo, Mississippi, United States
Southern Oncology Hematology
🇺🇸Vineland, New Jersey, United States
Broome Oncology
🇺🇸Johnson City, New York, United States
St John's Clinic for Cancer and Hematology
🇺🇸Springfield, Missouri, United States
Alamance Regional Cancer Center
🇺🇸Burlington, North Carolina, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Vassar Brothers Medical Center
🇺🇸Poughkeepsie, New York, United States
Gaston Hematology Oncology
🇺🇸Gastonia, North Carolina, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Lancaster General Health
🇺🇸Lancaster, Pennsylvania, United States
Berks Hematology-Oncology
🇺🇸West Reading, Pennsylvania, United States
Veterans Research Foundation of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Medical Oncology Associates of Wyoming Valley, PC
🇺🇸Kingston, Pennsylvania, United States
The Cancer Center at Memorial Hospital
🇺🇸Pawtucket, Rhode Island, United States
Texas Oncology-Methodist Charlton Cancer Center
🇺🇸Dallas, Texas, United States
Michael DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
Geisinger Health System
🇺🇸Wilkes-Barre, Pennsylvania, United States
Hematology Oncology Associates of Fredricksburg
🇺🇸Fredericksburg, Virginia, United States
St. Luke's Hospital and Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Texas Oncology
🇺🇸Waco, Texas, United States
Texas Oncology-Midland Allison Cancer Center
🇺🇸Midland, Texas, United States
Wheeling Hospital
🇺🇸Wheeling, West Virginia, United States
Texas Oncology-McAllen South Second
🇺🇸McAllen, Texas, United States
City Hospital - West Virginia University Hospital East
🇺🇸Martinsburg, West Virginia, United States
Julie & Ben Rogers Cancer Institute
🇺🇸Beaumont, Texas, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Texas Oncology - Arlington South
🇺🇸Arlington, Texas, United States
Texas Oncology-Medical City Dallas
🇺🇸Dallas, Texas, United States
Tennessee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States
Hematology and Oncology Associates of RI
🇺🇸Cranston, Rhode Island, United States
Cancer Care Association Of York
🇺🇸York, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Texas Oncology-Odessa West Texas Cancer Center
🇺🇸Odessa, Texas, United States
Texas Oncology-Dallas Presbyterian Hospital
🇺🇸Dallas, Texas, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
North Texas Regional Cancer Center
🇺🇸Plano, Texas, United States
Providence Cancer Center at Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
🇺🇸Yakima, Washington, United States
Danville Hematology & Oncology
🇺🇸Danville, Virginia, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Aspirus Regional Cancer Center
🇺🇸Wausau, Wisconsin, United States
Local Insitution
🇪🇸Toledo, Spain
Local Institution
🇪🇸Santiago De Compostela-A Coruña, Spain
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
St. Lukes Roosevelt Medical Center
🇺🇸New York, New York, United States
Sturdy Hematology & Oncology Associates
🇺🇸Attleboro, Massachusetts, United States
Signal Point Clinical Research Center, LLC
🇺🇸Middletown, Ohio, United States
Medical Center of Newark
🇺🇸Newark, Ohio, United States
Hematology/Oncology Salem LLP
🇺🇸Salem, Oregon, United States
Bms Clinical Research Center
🇺🇸Does Not Exist, New Jersey, United States
Peninsula Cancer Institute
🇺🇸Newport News, Virginia, United States
Blue Ridge Cancer Care
🇺🇸Roanoke, Virginia, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University Of Florida
🇺🇸Jacksonville, Florida, United States
Northwest Alabama Cancer Center
🇺🇸Muscle Shoals, Alabama, United States
Southwest Cancer Care Medical Group
🇺🇸Escondido, California, United States
Wilshire Oncology Medical Group, Inc
🇺🇸Glendora, California, United States
St. Joseph's Hospital
🇺🇸Orange, California, United States
Stockton Hematology Oncology
🇺🇸Stockton, California, United States
Tahoe Forest Health System Cancer Center
🇺🇸Truckee, California, United States
PMK Medical Group, Inc. DBA Ventura
🇺🇸Oxnard, California, United States
Hematology And Medical Oncology Of Southern Palm Beach County
🇺🇸Boynton Beach, Florida, United States
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
Central Florida Health Alliance
🇺🇸Leesburg, Florida, United States
Watson Clinic
🇺🇸Lakeland, Florida, United States
Florida Cancer Specialists
🇺🇸New Port Richey, Florida, United States
Lake County Oncology and Hematology
🇺🇸Tavares, Florida, United States
Space Coast Cancer Center
🇺🇸Titusville, Florida, United States
Georgia Cancer Specialist
🇺🇸Sandy Springs, Georgia, United States
Mid-Illinois Hem/Onc Asoc
🇺🇸Normal, Illinois, United States
Delnor Community Hospital
🇺🇸Geneva, Illinois, United States
Lewis Hall Singeltary Oncology Center
🇺🇸Thomasville, Georgia, United States
Mahafzah Medical Center
🇺🇸Evergreen Park, Illinois, United States
North Chicago VA Medical Center
🇺🇸North Chicago, Illinois, United States
Southern Illinois School of Medicine
🇺🇸Springfield, Illinois, United States
Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
Saint John's Cancer Center
🇺🇸Anderson, Indiana, United States
Horizon Oncology Research, Inc
🇺🇸Lafayette, Indiana, United States
Cancer Care Center, Inc. PC
🇺🇸New Albany, Indiana, United States
N. Iowa Mercy Cancer Center
🇺🇸Mason City, Iowa, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Broward Oncology Associates
🇺🇸Fort Lauderdale, Florida, United States
Northwest Georgia Oncology Centers, PC
🇺🇸Marietta, Georgia, United States
Pacific Cancer Medical Center, Inc
🇺🇸Anaheim, California, United States
Palm Springs Research Institute
🇺🇸Hialeah, Florida, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Cancer Centers of Florida
🇺🇸Orlando, Florida, United States
OnCare
🇺🇸Honolulu, Hawaii, United States
Straub Clinical & Hospital
🇺🇸Honolulu, Hawaii, United States
Kaiser Permanente Honolulu
🇺🇸Honolulu, Hawaii, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
University of Louisville Hospital - Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Omaha VAMC
🇺🇸Omaha, Nebraska, United States
Montefiore Medical Center / AECOM
🇺🇸Bronx, New York, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Texas Oncology-Austin North
🇺🇸Austin, Texas, United States
Swedish Cancer Institute-Eastside Hematology/Oncology
🇺🇸Bellevue, Washington, United States