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Chronic Myeloid LeukemiaSIMPLICITYNCT01244750

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

An observational study of Chronic Myeloid Leukemia, run by Bristol-Myers Squibb at 214 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia
How many people
1,494 participants
Where
214 sitesin 8 countries
Study dates
2 Dec 2010to 8 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be recruited at oncology practices or oncology centers linked to a hospital in the North Americas, Europe and potentially at additional sites in South America, and Asia

Who may be able to join

  • 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
  • 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
  • Dasatinib Cohort
Show all 11Show fewer
  • Patients who started their first-line Dasatinib treatment after the drug was approved in this indication
  • 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)

Who cannot join

  • 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

Trial locations and contacts

214 sites in 8 countries.

214 sites in 8 countries

United States143 sites

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Texas Oncology

    Amarillo, Texas, 79106

  • Pacific Cancer Medical Center, Inc

    Anaheim, California, 92801

  • Saint John's Cancer Center

    Anderson, Indiana, 46016

  • Texas Oncology - Arlington South

    Arlington, Texas, 76014

  • Peachtree Hematology-Oncology

    Atlanta, Georgia, 30318

  • Emory University

    Atlanta, Georgia, 30322

  • Sturdy Hematology & Oncology Associates

    Attleboro, Massachusetts, 02703

  • Texas Oncology-Austin North

    Austin, Texas, 78758

  • Julie & Ben Rogers Cancer Institute

    Beaumont, Texas, 77701

  • Swedish Cancer Institute-Eastside Hematology/Oncology

    Bellevue, Washington, 98005

  • St. Luke's Hospital and Health Network

    Bethlehem, Pennsylvania, 18015

  • Billings Clinic

    Billings, Montana, 59101

  • Boston VA Healthcare System

    Boston, Massachusetts, 02130

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • Hematology And Medical Oncology Of Southern Palm Beach County

    Boynton Beach, Florida, 33435

  • Alamance Regional Cancer Center

    Burlington, North Carolina, 27215

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • Maryland Oncology Hematology Pa

    Columbia, Maryland, 21044

  • Hematology and Oncology Associates of RI

    Cranston, Rhode Island, 02920

  • Texas Oncology-Medical City Dallas

    Dallas, Texas, 75230-2510

  • Texas Oncology-Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology-Methodist Charlton Cancer Center

    Dallas, Texas, 75237

  • Danville Hematology & Oncology

    Danville, Virginia, 24541

  • Bms Clinical Research Center

    Does Not Exist, New Jersey, 08690-3542

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Southwest Cancer Care Medical Group

    Escondido, California, 92025

  • Mahafzah Medical Center

    Evergreen Park, Illinois, 60805

  • South Coast Health System

    Fall River, Massachusetts, 02720

  • Broward Oncology Associates

    Fort Lauderdale, Florida, 33308

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • Hematology Oncology Associates of Fredricksburg

    Fredericksburg, Virginia, 22408

  • Gaston Hematology Oncology

    Gastonia, North Carolina, 28054

  • Delnor Community Hospital

    Geneva, Illinois, 60134

  • Wilshire Oncology Medical Group, Inc

    Glendora, California, 91741

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • East Carolina University

    Greenville, North Carolina, 27834

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Palm Springs Research Institute

    Hialeah, Florida, 33012

  • OnCare

    Honolulu, Hawaii, 96813

  • Straub Clinical & Hospital

    Honolulu, Hawaii, 96813

  • Kaiser Permanente Honolulu

    Honolulu, Hawaii, 96819

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Michael DeBakey VA Medical Center

    Houston, Texas, 77030

  • Hutchinson Clinic

    Hutchinson, Kansas, 67502

  • Indiana Blood and Marrow Transplantation

    Indianapolis, Indiana, 46237

  • Investigative Clinical Research of Indiana

    Indianapolis, Indiana, 46260

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • University Of Florida

    Jacksonville, Florida, 32209

  • Broome Oncology

    Johnson City, New York, 13790

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Medical Oncology Associates of Wyoming Valley, PC

    Kingston, Pennsylvania, 18704

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Horizon Oncology Research, Inc

    Lafayette, Indiana, 47905

  • Watson Clinic

    Lakeland, Florida, 33805

  • Lancaster General Health

    Lancaster, Pennsylvania, 17601

  • Michigan State University

    Lansing, Michigan, 48910

  • Central Florida Health Alliance

    Leesburg, Florida, 34748

  • Texas Oncology

    Lewisville, Texas, 75067

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Little Rock Hematology Oncology Associates

    Little Rock, Arkansas, 72205

  • University of Southern California

    Los Angeles, California, 90033

  • University of Louisville Hospital - Brown Cancer Center

    Louisville, Kentucky, 40202

  • Medical Oncology and Blood Disorders, LLP

    Manchester, Connecticut, 06040

  • Northwest Georgia Oncology Centers, PC

    Marietta, Georgia, 30060

  • City Hospital - West Virginia University Hospital East

    Martinsburg, West Virginia, 25401

  • N. Iowa Mercy Cancer Center

    Mason City, Iowa, 50401

  • Texas Oncology-McAllen South Second

    McAllen, Texas, 78503

  • Texas Oncology

    Mesquite, Texas, 75150

  • Baptist Cancer Center

    Miami, Florida

  • Signal Point Clinical Research Center, LLC

    Middletown, Ohio, 45042

  • Texas Oncology-Midland Allison Cancer Center

    Midland, Texas, 79701

  • Hematology-Oncology Associates of Northern NJ, PA

    Morristown, New Jersey, 07962

  • Northwest Alabama Cancer Center

    Muscle Shoals, Alabama, 35661

  • Cancer Care Center, Inc. PC

    New Albany, Indiana, 47150

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Florida Cancer Specialists

    New Port Richey, Florida, 34655

  • Advanced Oncology

    New York, New York, 10013

  • St. Lukes Roosevelt Medical Center

    New York, New York, 10019

  • Medical Center of Newark

    Newark, Ohio, 43055

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Mid-Illinois Hem/Onc Asoc

    Normal, Illinois, 61761

  • North Chicago VA Medical Center

    North Chicago, Illinois, 60064

  • Texas Oncology-Odessa West Texas Cancer Center

    Odessa, Texas, 79761

  • Omaha VAMC

    Omaha, Nebraska, 68105

  • St. Joseph's Hospital

    Orange, California, 92868

  • Cancer Centers of Florida

    Orlando, Florida, 32806

  • PMK Medical Group, Inc. DBA Ventura

    Oxnard, California, 93030

  • Texas Oncology

    Paris, Texas, 75460-5004

  • The Cancer Center at Memorial Hospital

    Pawtucket, Rhode Island, 02860

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85016

  • Veterans Research Foundation of Pittsburgh

    Pittsburgh, Pennsylvania, 15240

  • North Texas Regional Cancer Center

    Plano, Texas, 75075

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Portsmouth Regional Hospital

    Portsmouth, New Hampshire, 03801

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

  • Commonwealth Hematology-Oncology, P.C.

    Quincy, Massachusetts, 02169

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Consultants In Blood Disorders

    Saint Matthews, Kentucky, 40207

  • Hematology/Oncology Salem LLP

    Salem, Oregon, 97301

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78217

  • Georgia Cancer Specialist

    Sandy Springs, Georgia, 30342

  • Arizona Oncology Associates, PC - NAHOA

    Sedona, Arizona, 86336

  • Willis-Knighton Cancer System

    Shreveport, Louisiana, 71103

  • Avera Research Institute

    Sioux Falls, South Dakota, 57105

  • Providence Cancer Center at Sacred Heart Medical Center

    Spokane, Washington, 99208

  • Southern Illinois School of Medicine

    Springfield, Illinois, 62794

  • St John's Clinic for Cancer and Hematology

    Springfield, Missouri, 65807

  • Stamford Hospital

    Stamford, Connecticut, 06904

  • Stockton Hematology Oncology

    Stockton, California, 95204

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Lake County Oncology and Hematology

    Tavares, Florida, 32778

  • Montefiore Medical Center / AECOM

    The Bronx, New York, 10467

  • Lewis Hall Singeltary Oncology Center

    Thomasville, Georgia, 31792

  • Space Coast Cancer Center

    Titusville, Florida, 32796

  • Cotton O'Neil Cancer Center

    Topeka, Kansas, 66606

  • Tahoe Forest Health System Cancer Center

    Truckee, California, 96160

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85704

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • North Mississippi Hematology & Oncology

    Tupelo, Mississippi, 38801

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Southern Oncology Hematology

    Vineland, New Jersey, 08360

  • Texas Oncology

    Waco, Texas, 76712

  • Washington Hospital Center, Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

  • George Washington University

    Washington D.C., District of Columbia, 20237

  • Prairie Lakes Healthcare System, Inc

    Watertown, South Dakota, 57201

  • Aspirus Regional Cancer Center

    Wausau, Wisconsin, 53792

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Berks Hematology-Oncology

    West Reading, Pennsylvania, 19611

  • Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Geisinger Health System

    Wilkes-Barre, Pennsylvania, 18711

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • UMass Medical Center

    Worcester, Massachusetts, 01655

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington, 98902

  • Cancer Care Association Of York

    York, Pennsylvania, 17403

Other trials in United States

Germany36 sites

  • Local Institution

    Amberg, 92224

  • Local Institution

    Aschaffenburg

  • Local Institution

    Baden-Baden

  • Local Institution

    Bamberg, 96049

  • Local Institution

    Berlin, 12203

  • Local Institution

    Berlin, 13353

  • Local Institution

    Bonn, 53105

  • Local Institution

    Bottrop, 46236

  • Local Institution

    Coburg, 96450

  • Local Institution

    Cologne, 50674

  • Local Institution

    Cologne, 50677

  • Local Institution

    Darmstadt, 64283

  • Local Institution

    Essen, 45136

  • Local Institution

    Frankfurt am Main

  • Local Institution

    Frankurt Am Main, 60389

  • Local Institution

    Greifswald, 17475

  • Local Institution

    Hamm, 59063

  • Local Institution

    Hof, 95028

  • Local Institution

    Idar-Oberstein, 55743

  • Local Institution

    Kaiserslautern

  • Local Institution

    Kassel, 34117

  • Local Institution

    Koblenz, 56068

  • Local Institution

    Landshut, 84028

  • Local Institution

    Lebach, 66822

  • Local Institution

    Leipzig, 04103

  • Local Institution

    Mülheim A. D. Ruhr, 45468

  • Local Institution

    Offenbach

  • Local Institution

    Potsdam, 14467

  • Local Institution

    Rostock, 18057

  • Local Institution

    Rötha, 04571

  • Local Institution

    Singen, 78224

  • Local Institution

    Soest, 59494

  • Local Institution

    Ulm, 89081

  • Local Institution

    Velbert, 42551

  • Local Institution

    Weiden, 92637

  • Local Institution

    Würzburg, 97080

Other trials in Germany

Italy19 sites

  • Local Institution

    Bari, 70124

  • Local Institution

    Brescia, 25123

  • Local Institution

    Brindisi, 72100

  • Local Institution

    Catania, 95124

  • Local Institution

    Florence, 50134

  • Local Institution

    Milan, 20122

  • Local Institution

    Milan, 20162

  • Local Institution

    Modena, 44100

  • Local Institution

    Monza, 20052

  • Local Institution

    Pavia, 27100

  • Local Institution

    Perugia, 06156

  • Local Institution

    Pesaro, 61122

  • Local Institution

    Rionero in Vulture, 85028

  • Local Institution

    Roma, 00189

  • Local Institution

    Rome, 00161

  • Local Institution

    Rome, 00168

  • Local Institution

    Siena, 53100

  • Local Institution

    Terni, 05100

  • Local Institution

    Udine, 33100

Other trials in Italy

France7 sites

  • Local Institution

    Blois, 41016

  • Local Institution

    Bordeaux, 33300

  • Local Institution

    Chalon/Saone Cedex, 71100

  • Local Institution

    Chambéry, 73011

  • Local Institution

    Le Mans, 72037

  • Local Institution

    Pierre-Bénite, 69495

  • Local Institution

    Pringy, 74374

Other trials in France

Spain6 sites

  • Local Institution

    A Coruña, 15006

  • Local Institution

    Oviedo - Asturias, 33006

  • Local Institution

    Pamplona, 31008

  • Local Institution

    Salamanca, 37007

  • Local Institution

    Santiago de Compostela-A Coruña, Spain, 15706

  • Local Insitution

    Toledo, 45004

Other trials in Spain

Netherlands1 site

  • Local Institution

    Hoofddorp, 2134 TM

Other trials in Netherlands

Puerto Rico1 site

  • Puerto Rico Hematology Oncology Group

    Bayamón, 00961

Other trials in Puerto Rico

Russia1 site

  • Local Institution

    Saint Petersburg, 197022

Other trials in Russia

About this study

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

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.

Read the 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)

Keywords
Chronic Phase - Chronic Myeloid Leukemia
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01244750
Study groupRoleWhat they receive
First line TKI treatment: ImatinibDiagnosed CML patients who receive first line TKI treatment: Imatinib
First line TKI treatment: NilotinibDiagnosed CML patients who receive first line TKI treatment: Nilotinib
First line TKI treatment: DasatinibDiagnosed CML patients who receive first line TKI treatment: Dasatinib
Imatinib treated patientsImatinib treated patients if their study index date is between January 2, 2008 and September 30, 2010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of Complete Cytogenetic Response

    Measured: 12 months

  2. The duration of initial TKI treatment

    Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)

    Measured: 5-years from study index date

  3. 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)

    Measured: Every 6 months for a follow-up period of 5-years from study index date

  4. 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

    Measured: Every 6 months for a follow-up period of 5-years from study index date

  5. The adherence to treatment

    Morisky Medication Adherence Scale - 8 Items is a validated self-reported measure of medication adherence.

    Measured: Every 6 months for a follow-up period of 5-years from study index date

Secondary outcomes (5)

  1. 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).

    Measured: Every 6 months

  2. Non-hematologic side effects from treatment affecting patient quality of life and outcomes

    Treatment discontinuations and changes

    Measured: Every 6 months

  3. Patient satisfaction with CML treatment

    Cancer Therapy Satisfaction Questionnaire (CTSQ)

    Measured: Every 6 months

  4. 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

    Measured: Every 6 months

  5. 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.

    Measured: Every 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2010 (estimated)
  2. Study start2 Dec 2010
  3. Primary completion8 Jan 2020
  4. Study completion8 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,494 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01244750
Sponsor's protocol ID
CA180-330
Acronym
SIMPLICITY
Status last verified
Jun 2022
First submitted
15 Nov 2010
Last updated
30 Jun 2022
Results posted
No
Data monitoring committee
No

Publications

  • Hehlmann R, Cortes JE, Zyczynski T, Gambacorti-Passerini C, Goldberg SL, Mauro MJ, Michallet M, Simonsson B, Williams LA, Gajavelli S, DeGutis I, Sen GP, Paquette RL. Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice: SIMPLICITY. Am J Hematol. 2019 Jan;94(1):46-54. doi: 10.1002/ajh.25306. Epub 2018 Oct 31.

    PubMed 30290003

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Myeloid Leukemia, run by Bristol-Myers Squibb at 214 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 214 sites in United States, Germany, Italy, France, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of Complete Cytogenetic Response (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01244750, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.

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