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

• ClinicalTrials.gov Identifier: NCT01244750
• Recruitment Status: Active, not recruiting
• First Posted: November 19, 2010
• Last Update Posted: January 23, 2018
• Sponsor: Bristol-Myers Squibb
• Collaborator: ICON Clinical Research
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

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.

Condition or disease	Intervention/treatment
Chronic Myeloid Leukemia	Other: Non-Interventional

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)

Study Design

• Study Type: Observational
• Actual Enrollment: 1494 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)
• Actual Study Start Date: December 2, 2010
• Estimated Primary Completion Date: January 30, 2020
• Estimated Study Completion Date: August 30, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
First line TKI treatment: Imatinib; Diagnosed CML patients who receive first line TKI treatment: Imatinib	Other: Non-Interventional; Non-Interventional
First line TKI treatment: Nilotinib; Diagnosed CML patients who receive first line TKI treatment: Nilotinib	Other: Non-Interventional; Non-Interventional
First line TKI treatment: Dasatinib; Diagnosed CML patients who receive first line TKI treatment: Dasatinib	Other: Non-Interventional; Non-Interventional
Imatinib treated patients; Imatinib treated patients if their study index date is between January 2, 2008 and September 30, 2010	Other: Non-Interventional; Non-Interventional

Outcome Measures

Primary Outcome Measures :

1. The rate of Complete Cytogenetic Response [ Time Frame: 12 months ]
2. The duration of initial TKI treatment [ Time Frame: 5-years from study index date ]
   Initiation of first-line TKI, (whether Dasatinib, Imatinib, Nilotinib)
3. The rate of discontinuation and treatment changes after initial TKI treatment [ Time Frame: 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)
4. The rate of best response to therapy (i.e. hematologic, cytogenetic, molecular response) [ Time Frame: 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
5. The adherence to treatment [ Time Frame: 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 :

1. Impact of first-line treatment options on quality of life [ Time Frame: 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).

2. Non-hematologic side effects from treatment affecting patient quality of life and outcomes [ Time Frame: Every 6 months ]
   Treatment discontinuations and changes
3. Patient satisfaction with CML treatment [ Time Frame: Every 6 months ]
   Cancer Therapy Satisfaction Questionnaire (CTSQ)
4. Patterns of disease monitoring as observed in a real-world setting [ Time Frame: 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
5. Resource utilization associated with CML management [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

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

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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

Contacts and Locations

  Hide Study Locations

Locations

United States, Alabama

Northwest Alabama Cancer Center

Muscle Shoals, Alabama, United States, 35661

United States, Arizona

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States, 85016

Arizona Oncology Associates, PC - NAHOA

Sedona, Arizona, United States, 86336

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, United States, 85704

United States, Arkansas

Genesis Cancer Center

Hot Springs National Park, Arkansas, United States, 71913

NEA Baptist Clinic

Jonesboro, Arkansas, United States, 72401

Little Rock Hematology Oncology Associates

Little Rock, Arkansas, United States, 72205

United States, California

Pacific Cancer Medical Center, Inc

Anaheim, California, United States, 92801

Southwest Cancer Care Medical Group

Escondido, California, United States, 92025

Wilshire Oncology Medical Group, Inc

Glendora, California, United States, 91741

University of Southern California

Los Angeles, California, United States, 90033

St. Joseph's Hospital

Orange, California, United States, 92868

PMK Medical Group, Inc. DBA Ventura

Oxnard, California, United States, 93030

Stockton Hematology Oncology

Stockton, California, United States, 95204

Tahoe Forest Health System Cancer Center

Truckee, California, United States, 96160

United States, Colorado

Rocky Mountain Cancer Centers

Boulder, Colorado, United States, 80303

United States, Connecticut

Medical Oncology and Blood Disorders, LLP

Manchester, Connecticut, United States, 06040

Stamford Hospital

Stamford, Connecticut, United States, 06904

United States, District of Columbia

Washington Hospital Center, Washington Cancer Institute

Washington, District of Columbia, United States, 20010

George Washington University

Washington, District of Columbia, United States, 20237

United States, Florida

Hematology And Medical Oncology Of Southern Palm Beach County

Boynton Beach, Florida, United States, 33435

Broward Oncology Associates

Fort Lauderdale, Florida, United States, 33308

Palm Springs Research Institute

Hialeah, Florida, United States, 33012

Baptist Cancer Institute

Jacksonville, Florida, United States, 32207

University Of Florida

Jacksonville, Florida, United States, 32209

Watson Clinic

Lakeland, Florida, United States, 33805

Central Florida Health Alliance

Leesburg, Florida, United States, 34748

Baptist Cancer Center

Miami, Florida, United States

Florida Cancer Specialists

New Port Richey, Florida, United States, 34655

Cancer Centers of Florida

Orlando, Florida, United States, 32806

Lake County Oncology and Hematology

Tavares, Florida, United States, 32778

Space Coast Cancer Center

Titusville, Florida, United States, 32796

United States, Georgia

Peachtree Hematology-Oncology

Atlanta, Georgia, United States, 30318

Emory University

Atlanta, Georgia, United States, 30322

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, United States, 30060

Georgia Cancer Specialist

Sandy Springs, Georgia, United States, 30342

Lewis Hall Singeltary Oncology Center

Thomasville, Georgia, United States, 31792

United States, Hawaii

OnCare

Honolulu, Hawaii, United States, 96813

Straub Clinical & Hospital

Honolulu, Hawaii, United States, 96813

Kaiser Permanente Honolulu

Honolulu, Hawaii, United States, 96819

United States, Illinois

Mahafzah Medical Center

Evergreen Park, Illinois, United States, 60805

Delnor Community Hospital

Geneva, Illinois, United States, 60134

Orchard Health Care Research

Niles, Illinois, United States, 60076

Mid-Illinois Hem/Onc Asoc

Normal, Illinois, United States, 61761

North Chicago VA Medical Center

North Chicago, Illinois, United States, 60064

Southern Illinois School of Medicine

Springfield, Illinois, United States, 62794

Carle Cancer Center

Urbana, Illinois, United States, 61801

Central DuPage Hospital

Winfield, Illinois, United States, 60190

United States, Indiana

Saint John's Cancer Center

Anderson, Indiana, United States, 46016

Indiana Blood and Marrow Transplantation

Indianapolis, Indiana, United States, 46237

Investigative Clinical Research of Indiana

Indianapolis, Indiana, United States, 46260

Horizon Oncology Research, Inc

Lafayette, Indiana, United States, 47905

Cancer Care Center, Inc. PC

New Albany, Indiana, United States, 47150

United States, Iowa

N. Iowa Mercy Cancer Center

Mason City, Iowa, United States, 50401

United States, Kansas

Hutchinson Clinic

Hutchinson, Kansas, United States, 67502

Cotton O'Neil Cancer Center

Topeka, Kansas, United States, 66606

Cancer Center of Kansas

Wichita, Kansas, United States, 67214

United States, Kentucky

Central Baptist Hospital

Lexington, Kentucky, United States, 40503

University of Louisville Hospital - Brown Cancer Center

Louisville, Kentucky, United States, 40202

Consultants In Blood Disorders

Saint Matthews, Kentucky, United States, 40207

United States, Louisiana

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

Willis-Knighton Cancer System

Shreveport, Louisiana, United States, 71103

United States, Maryland

Maryland Oncology Hematology Pa

Columbia, Maryland, United States, 21044

Frederick Memorial Hospital

Frederick, Maryland, United States, 21701

United States, Massachusetts

Sturdy Hematology & Oncology Associates

Attleboro, Massachusetts, United States, 02703

Boston VA Healthcare System

Boston, Massachusetts, United States, 02130

South Coast Health System

Fall River, Massachusetts, United States, 02720

Commonwealth Hematology-Oncology, P.C.

Quincy, Massachusetts, United States, 02169

UMass Medical Center

Worcester, Massachusetts, United States, 01655

United States, Michigan

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States, 49503

West Michigan Cancer Center

Kalamazoo, Michigan, United States, 49007

Michigan State University

Lansing, Michigan, United States, 48910

United States, Mississippi

North Mississippi Hematology & Oncology

Tupelo, Mississippi, United States, 38801

United States, Missouri

St John's Clinic for Cancer and Hematology

Springfield, Missouri, United States, 65807

United States, Montana

Billings Clinic

Billings, Montana, United States, 59101

United States, Nebraska

Omaha VAMC

Omaha, Nebraska, United States, 68105

United States, New Hampshire

Portsmouth Regional Hospital

Portsmouth, New Hampshire, United States, 03801

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Hematology-Oncology Associates of Northern NJ, PA

Morristown, New Jersey, United States, 07962

Southern Oncology Hematology

Vineland, New Jersey, United States, 08360

United States, New York

Montefiore Medical Center / AECOM

Bronx, New York, United States, 10467

Broome Oncology

Johnson City, New York, United States, 13790

Advanced Oncology

New York, New York, United States, 10013

St. Lukes Roosevelt Medical Center

New York, New York, United States, 10019

Vassar Brothers Medical Center

Poughkeepsie, New York, United States, 12601

Stony Brook University Hospital

Stony Brook, New York, United States, 11794

United States, North Carolina

Alamance Regional Cancer Center

Burlington, North Carolina, United States, 27215

Waverly Hematology Oncology

Cary, North Carolina, United States, 27518

Duke University Medical Center

Durham, North Carolina, United States, 27710

Gaston Hematology Oncology

Gastonia, North Carolina, United States, 28054

East Carolina University

Greenville, North Carolina, United States, 27834

United States, Ohio

Akron General Medical Center

Akron, Ohio, United States, 44302

Gabrail Cancer Center

Canton, Ohio, United States, 44718

Signal Point Clinical Research Center, LLC

Middletown, Ohio, United States, 45042

Medical Center of Newark

Newark, Ohio, United States, 43055

United States, Oklahoma

Cancer Care Associates

Tulsa, Oklahoma, United States, 74136

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

Hematology/Oncology Salem LLP

Salem, Oregon, United States, 97301

United States, Pennsylvania

Lehigh Valley Hospital

Allentown, Pennsylvania, United States, 18103

St. Luke's Hospital and Health Network

Bethlehem, Pennsylvania, United States, 18015

Medical Oncology Associates of Wyoming Valley, PC

Kingston, Pennsylvania, United States, 18704

Lancaster General Health

Lancaster, Pennsylvania, United States, 17601

Veterans Research Foundation of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15240

Berks Hematology-Oncology

West Reading, Pennsylvania, United States, 19611

Geisinger Health System

Wilkes-Barre, Pennsylvania, United States, 18711

Cancer Care Association Of York

York, Pennsylvania, United States, 17403

United States, Rhode Island

Hematology and Oncology Associates of RI

Cranston, Rhode Island, United States, 02920

The Cancer Center at Memorial Hospital

Pawtucket, Rhode Island, United States, 02860

United States, South Carolina

Charleston Cancer Center

Charleston, South Carolina, United States, 29406

United States, South Dakota

Avera Research Institute

Sioux Falls, South Dakota, United States, 57105

Prairie Lakes Healthcare System, Inc

Watertown, South Dakota, United States, 57201

United States, Tennessee

Tennessee Cancer Specialists

Knoxville, Tennessee, United States, 37909

University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

United States, Texas

Texas Oncology

Amarillo, Texas, United States, 79106

Texas Oncology - Arlington South

Arlington, Texas, United States, 76014

Texas Oncology-Austin North

Austin, Texas, United States, 78758

Julie & Ben Rogers Cancer Institute

Beaumont, Texas, United States, 77701

Texas Oncology-Medical City Dallas

Dallas, Texas, United States, 75230-2510

Texas Oncology-Dallas Presbyterian Hospital

Dallas, Texas, United States, 75231

Texas Oncology-Methodist Charlton Cancer Center

Dallas, Texas, United States, 75237

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Michael DeBakey VA Medical Center

Houston, Texas, United States, 77030

Texas Oncology

Lewisville, Texas, United States, 75067

Texas Oncology-McAllen South Second

McAllen, Texas, United States, 78503

Texas Oncology

Mesquite, Texas, United States, 75150

Texas Oncology-Midland Allison Cancer Center

Midland, Texas, United States, 79701

Texas Oncology-Odessa West Texas Cancer Center

Odessa, Texas, United States, 79761

Texas Oncology

Paris, Texas, United States, 75460-5004

North Texas Regional Cancer Center

Plano, Texas, United States, 75075

Cancer Care Centers of South Texas

San Antonio, Texas, United States, 78217

Texas Oncology

Waco, Texas, United States, 76712

United States, Virginia

Danville Hematology & Oncology

Danville, Virginia, United States, 24541

Hematology Oncology Associates of Fredricksburg

Fredericksburg, Virginia, United States, 22408

Peninsula Cancer Institute

Newport News, Virginia, United States, 23601

Blue Ridge Cancer Care

Roanoke, Virginia, United States, 24014

United States, Washington

Swedish Cancer Institute-Eastside Hematology/Oncology

Bellevue, Washington, United States, 98005

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, United States, 99208

Wenatchee Valley Medical Center

Wenatchee, Washington, United States, 98801

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, United States, 98902

United States, West Virginia

Charleston Area Medical Center

Charleston, West Virginia, United States, 25304

City Hospital - West Virginia University Hospital East

Martinsburg, West Virginia, United States, 25401

Wheeling Hospital

Wheeling, West Virginia, United States, 26003

United States, Wisconsin

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States, 53792

France

Local Institution

Blois cedex, France, 41016

Local Institution

Bordeaux, France, 33300

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Chalon/Saone Cedex, France, 71100

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Chambéry, France, 73011

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Le Mans Cedex 09, France, 72037

Local Institution

Pierre Benite, France, 69495

Local Institution

PRINGY cedex, France, 74374

Germany

Local Institution

Amberg, Germany, 92224

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Aschaffenburg, Germany

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Baden-Baden, Germany

Local Institution

Bamberg, Germany, 96049

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Berlin, Germany, 12203

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Berlin, Germany, 13353

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Bonn, Germany, 53105

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Bottrop, Germany, 46236

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Coburg, Germany, 96450

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Darmstadt, Germany, 64283

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Essen, Germany, 45136

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Frankfurt am Main, Germany

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Frankurt am Main, Germany, 60389

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Greifswald, Germany, 17475

Local Institution

Hamm, Germany, 59063

Local Institution

Hof, Germany, 95028

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Idar-Oberstein, Germany, 55743

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Kaiserslautern, Germany

Local Institution

Kassel, Germany, 34117

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Koblenz, Germany, 56068

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Köln, Germany, 50674

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Köln, Germany, 50677

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Landshut, Germany, 84028

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Lebach, Germany, 66822

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Leipzig, Germany, 04103

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Mülheim A. D. Ruhr, Germany, 45468

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Offenbach, Germany

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Potsdam, Germany, 14467

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Rostock, Germany, 18057

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Rötha, Germany, 04571

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Singen, Germany, 78224

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Soest, Germany, 59494

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Ulm, Germany, 89081

Local Institution

Velbert, Germany, 42551

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Weiden, Germany, 92637

Local Institution

Würzburg, Germany, 97080

Italy

Local Institution

Bari, Italy, 70124

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Brescia, Italy, 25123

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Brindisi, Italy, 72100

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Catania, Italy, 95124

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Florence, Italy, 50134

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Milano, Italy, 20162

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Milan, Italy, 20122

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Modena, Italy, 44100

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Monza, Italy, 20052

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Pavia, Italy, 27100

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Perugia, Italy, 06156

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Pesaro, Italy, 61122

Local Institution

Rionero in Vulture, Italy, 85028

Local Institution

Roma, Italy, 00189

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Rome, Italy, 00161

Local Institution

Rome, Italy, 00168

Local Institution

Siena, Italy, 53100

Local Institution

Terni, Italy, 05100

Local Institution

Udine, Italy, 33100

Netherlands

Local Institution

Hoofddorp, Netherlands, 2134 TM

Puerto Rico

Puerto Rico Hematology Oncology Group

Bayamon, Puerto Rico, 00961

Russian Federation

Local Institution

Saint-Petersburg, Russian Federation, 197022

Spain

Local Institution

La Coruña, Spain, 15006

Local Institution

Oviedo - Asturias, Spain, 33006

Local Institution

Pamplona, Spain, 31008

Local Institution

Salamanca, Spain, 37007

Local Institution

Santiago De Compostela-A Coruña, Spain, 15706

Local Insitution

Toledo, Spain, 45004

Sponsors and Collaborators

Bristol-Myers Squibb

ICON Clinical Research

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure  Investigator Inquiry form  For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01244750 History of Changes
• Other Study ID Numbers: CA180-330
• First Posted: November 19, 2010
• Last Update Posted: January 23, 2018
• Last Verified: January 2018

Keywords provided by Bristol-Myers Squibb:

Chronic Phase - Chronic Myeloid Leukemia

Additional relevant MeSH terms:

Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Imatinib Mesylate; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action