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

Chronic Myeloid Leukemia Clinical Trial

— SIMPLICITY  

Official title:

Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244750
• Other study ID #: CA180-330
• Status: Completed
• Start date: December 2, 2010
• Est. completion date: January 8, 2020

Study information

• Verified date: June 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1494
• Est. completion date: January 8, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Locations

Country	Name	City	State
France	Local Institution	Blois cedex
France	Local Institution	Bordeaux
France	Local Institution	Chalon/Saone Cedex
France	Local Institution	Chambéry
France	Local Institution	Le Mans Cedex 09
France	Local Institution	Pierre Benite
France	Local Institution	PRINGY cedex
Germany	Local Institution	Amberg
Germany	Local Institution	Aschaffenburg
Germany	Local Institution	Baden-Baden
Germany	Local Institution	Bamberg
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Bonn
Germany	Local Institution	Bottrop
Germany	Local Institution	Coburg
Germany	Local Institution	Darmstadt
Germany	Local Institution	Essen
Germany	Local Institution	Frankfurt am Main
Germany	Local Institution	Frankurt am Main
Germany	Local Institution	Greifswald
Germany	Local Institution	Hamm
Germany	Local Institution	Hof
Germany	Local Institution	Idar-Oberstein
Germany	Local Institution	Kaiserslautern
Germany	Local Institution	Kassel
Germany	Local Institution	Koblenz
Germany	Local Institution	Köln
Germany	Local Institution	Köln
Germany	Local Institution	Landshut
Germany	Local Institution	Lebach
Germany	Local Institution	Leipzig
Germany	Local Institution	Mülheim A. D. Ruhr
Germany	Local Institution	Offenbach
Germany	Local Institution	Potsdam
Germany	Local Institution	Rostock
Germany	Local Institution	Rötha
Germany	Local Institution	Singen
Germany	Local Institution	Soest
Germany	Local Institution	Ulm
Germany	Local Institution	Velbert
Germany	Local Institution	Weiden
Germany	Local Institution	Würzburg
Italy	Local Institution	Bari
Italy	Local Institution	Brescia
Italy	Local Institution	Brindisi
Italy	Local Institution	Catania
Italy	Local Institution	Florence
Italy	Local Institution	Milan
Italy	Local Institution	Milano
Italy	Local Institution	Modena
Italy	Local Institution	Monza
Italy	Local Institution	Pavia
Italy	Local Institution	Perugia
Italy	Local Institution	Pesaro
Italy	Local Institution	Rionero in Vulture
Italy	Local Institution	Roma
Italy	Local Institution	Rome
Italy	Local Institution	Rome
Italy	Local Institution	Siena
Italy	Local Institution	Terni
Italy	Local Institution	Udine
Netherlands	Local Institution	Hoofddorp
Puerto Rico	Puerto Rico Hematology Oncology Group	Bayamon
Russian Federation	Local Institution	Saint-Petersburg
Spain	Local Institution	La Coruña
Spain	Local Institution	Oviedo - Asturias
Spain	Local Institution	Pamplona
Spain	Local Institution	Salamanca
Spain	Local Institution	Santiago De Compostela-A Coruña
Spain	Local Insitution	Toledo
United States	Akron General Medical Center	Akron	Ohio
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Texas Oncology	Amarillo	Texas
United States	Pacific Cancer Medical Center, Inc	Anaheim	California
United States	Saint John's Cancer Center	Anderson	Indiana
United States	Texas Oncology - Arlington South	Arlington	Texas
United States	Emory University	Atlanta	Georgia
United States	Peachtree Hematology-Oncology	Atlanta	Georgia
United States	Sturdy Hematology & Oncology Associates	Attleboro	Massachusetts
United States	Texas Oncology-Austin North	Austin	Texas
United States	Julie & Ben Rogers Cancer Institute	Beaumont	Texas
United States	Swedish Cancer Institute-Eastside Hematology/Oncology	Bellevue	Washington
United States	St. Luke's Hospital and Health Network	Bethlehem	Pennsylvania
United States	Billings Clinic	Billings	Montana
United States	Boston VA Healthcare System	Boston	Massachusetts
United States	Rocky Mountain Cancer Centers	Boulder	Colorado
United States	Hematology And Medical Oncology Of Southern Palm Beach County	Boynton Beach	Florida
United States	Montefiore Medical Center / AECOM	Bronx	New York
United States	Alamance Regional Cancer Center	Burlington	North Carolina
United States	Gabrail Cancer Center	Canton	Ohio
United States	Waverly Hematology Oncology	Cary	North Carolina
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Charleston Cancer Center	Charleston	South Carolina
United States	Maryland Oncology Hematology Pa	Columbia	Maryland
United States	Hematology and Oncology Associates of RI	Cranston	Rhode Island
United States	Texas Oncology-Dallas Presbyterian Hospital	Dallas	Texas
United States	Texas Oncology-Medical City Dallas	Dallas	Texas
United States	Texas Oncology-Methodist Charlton Cancer Center	Dallas	Texas
United States	Danville Hematology & Oncology	Danville	Virginia
United States	Bms Clinical Research Center	Does Not Exist	New Jersey
United States	Duke University Medical Center	Durham	North Carolina
United States	Southwest Cancer Care Medical Group	Escondido	California
United States	Mahafzah Medical Center	Evergreen Park	Illinois
United States	South Coast Health System	Fall River	Massachusetts
United States	Broward Oncology Associates	Fort Lauderdale	Florida
United States	Frederick Memorial Hospital	Frederick	Maryland
United States	Hematology Oncology Associates of Fredricksburg	Fredericksburg	Virginia
United States	Gaston Hematology Oncology	Gastonia	North Carolina
United States	Delnor Community Hospital	Geneva	Illinois
United States	Wilshire Oncology Medical Group, Inc	Glendora	California
United States	Cancer & Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	East Carolina University	Greenville	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Palm Springs Research Institute	Hialeah	Florida
United States	Kaiser Permanente Honolulu	Honolulu	Hawaii
United States	OnCare	Honolulu	Hawaii
United States	Straub Clinical & Hospital	Honolulu	Hawaii
United States	Genesis Cancer Center	Hot Springs National Park	Arkansas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Michael DeBakey VA Medical Center	Houston	Texas
United States	Hutchinson Clinic	Hutchinson	Kansas
United States	Indiana Blood and Marrow Transplantation	Indianapolis	Indiana
United States	Investigative Clinical Research of Indiana	Indianapolis	Indiana
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	University Of Florida	Jacksonville	Florida
United States	Broome Oncology	Johnson City	New York
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Medical Oncology Associates of Wyoming Valley, PC	Kingston	Pennsylvania
United States	Tennessee Cancer Specialists	Knoxville	Tennessee
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Horizon Oncology Research, Inc	Lafayette	Indiana
United States	Watson Clinic	Lakeland	Florida
United States	Lancaster General Health	Lancaster	Pennsylvania
United States	Michigan State University	Lansing	Michigan
United States	Central Florida Health Alliance	Leesburg	Florida
United States	Texas Oncology	Lewisville	Texas
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Little Rock Hematology Oncology Associates	Little Rock	Arkansas
United States	University of Southern California	Los Angeles	California
United States	University of Louisville Hospital - Brown Cancer Center	Louisville	Kentucky
United States	Medical Oncology and Blood Disorders, LLP	Manchester	Connecticut
United States	Northwest Georgia Oncology Centers, PC	Marietta	Georgia
United States	City Hospital - West Virginia University Hospital East	Martinsburg	West Virginia
United States	N. Iowa Mercy Cancer Center	Mason City	Iowa
United States	Texas Oncology-McAllen South Second	McAllen	Texas
United States	Texas Oncology	Mesquite	Texas
United States	Baptist Cancer Center	Miami	Florida
United States	Signal Point Clinical Research Center, LLC	Middletown	Ohio
United States	Texas Oncology-Midland Allison Cancer Center	Midland	Texas
United States	Hematology-Oncology Associates of Northern NJ, PA	Morristown	New Jersey
United States	Northwest Alabama Cancer Center	Muscle Shoals	Alabama
United States	Cancer Care Center, Inc. PC	New Albany	Indiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Florida Cancer Specialists	New Port Richey	Florida
United States	Advanced Oncology	New York	New York
United States	St. Lukes Roosevelt Medical Center	New York	New York
United States	Medical Center of Newark	Newark	Ohio
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Mid-Illinois Hem/Onc Asoc	Normal	Illinois
United States	North Chicago VA Medical Center	North Chicago	Illinois
United States	Texas Oncology-Odessa West Texas Cancer Center	Odessa	Texas
United States	Omaha VAMC	Omaha	Nebraska
United States	St. Joseph's Hospital	Orange	California
United States	Cancer Centers of Florida	Orlando	Florida
United States	PMK Medical Group, Inc. DBA Ventura	Oxnard	California
United States	Texas Oncology	Paris	Texas
United States	The Cancer Center at Memorial Hospital	Pawtucket	Rhode Island
United States	Arizona Oncology Associates, PC - HAL	Phoenix	Arizona
United States	Veterans Research Foundation of Pittsburgh	Pittsburgh	Pennsylvania
United States	North Texas Regional Cancer Center	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Portsmouth Regional Hospital	Portsmouth	New Hampshire
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Commonwealth Hematology-Oncology, P.C.	Quincy	Massachusetts
United States	Blue Ridge Cancer Care	Roanoke	Virginia
United States	Consultants In Blood Disorders	Saint Matthews	Kentucky
United States	Hematology/Oncology Salem LLP	Salem	Oregon
United States	Cancer Care Centers of South Texas	San Antonio	Texas
United States	Georgia Cancer Specialist	Sandy Springs	Georgia
United States	Arizona Oncology Associates, PC - NAHOA	Sedona	Arizona
United States	Willis-Knighton Cancer System	Shreveport	Louisiana
United States	Avera Research Institute	Sioux Falls	South Dakota
United States	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington
United States	Southern Illinois School of Medicine	Springfield	Illinois
United States	St John's Clinic for Cancer and Hematology	Springfield	Missouri
United States	Stamford Hospital	Stamford	Connecticut
United States	Stockton Hematology Oncology	Stockton	California
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Lake County Oncology and Hematology	Tavares	Florida
United States	Lewis Hall Singeltary Oncology Center	Thomasville	Georgia
United States	Space Coast Cancer Center	Titusville	Florida
United States	Cotton O'Neil Cancer Center	Topeka	Kansas
United States	Tahoe Forest Health System Cancer Center	Truckee	California
United States	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona
United States	Cancer Care Associates	Tulsa	Oklahoma
United States	North Mississippi Hematology & Oncology	Tupelo	Mississippi
United States	Carle Cancer Center	Urbana	Illinois
United States	Southern Oncology Hematology	Vineland	New Jersey
United States	Texas Oncology	Waco	Texas
United States	George Washington University	Washington	District of Columbia
United States	Washington Hospital Center, Washington Cancer Institute	Washington	District of Columbia
United States	Prairie Lakes Healthcare System, Inc	Watertown	South Dakota
United States	Aspirus Regional Cancer Center	Wausau	Wisconsin
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Berks Hematology-Oncology	West Reading	Pennsylvania
United States	Wheeling Hospital	Wheeling	West Virginia
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Geisinger Health System	Wilkes-Barre	Pennsylvania
United States	Central DuPage Hospital	Winfield	Illinois
United States	UMass Medical Center	Worcester	Massachusetts
United States	Yakima Valley Memorial Hospital/North Star Lodge	Yakima	Washington
United States	Cancer Care Association Of York	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	ICON Clinical Research

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Netherlands,  Puerto Rico,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of Complete Cytogenetic Response		12 months
Primary	The duration of initial TKI treatment	Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)	5-years from study index date
Primary	The rate of discontinuation and treatment changes after initial TKI treatment	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)	Every 6 months for a follow-up period of 5-years from study index date
Primary	The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response)	Results and dates of: all bone marrow aspirates, blood tests, cytogenetics, Polymerase Chain Reaction (PCR), Fluorescent In-Situ Hybridization (FISH), and Physical exam	Every 6 months for a follow-up period of 5-years from study index date
Primary	The adherence to treatment	Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.	Every 6 months for a follow-up period of 5-years from study index date
Secondary	Impact of first-line treatment options on quality of life	Questionnaires used for assessment: Functional Assessment of Cancer Therapy - General (FACT-G), Cancer Therapy Satisfaction Questionnaire (CTSQ), MD Anderson Symptom Inventory - CML (MDASI-CML).	Every 6 months
Secondary	Non-hematologic side effects from treatment affecting patient quality of life and outcomes	Treatment discontinuations and changes	Every 6 months
Secondary	Patient satisfaction with CML treatment	Cancer Therapy Satisfaction Questionnaire (CTSQ)	Every 6 months
Secondary	Patterns of disease monitoring as observed in a real-world setting	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	Every 6 months
Secondary	Resource utilization associated with CML management	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.	Every 6 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls