- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01081015
Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
May 8, 2020 updated by: Celgene
The purpose of the Connect™ Chronic Lymphocytic Leukemia (CLL) Disease Registry is to explore the history and real world management of patients diagnosed with CLL, provide insight into the management of CLL, and evaluate the effectiveness of first, second and subsequent therapeutic strategies employed in both the community and academic settings.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1494
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Pomona, California, United States, 91767
- New Hope Cancer & Research Institute
-
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Florida
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Atlantis, Florida, United States, 33462
- Medical Specialists of the Palm Beaches
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Boynton Beach, Florida, United States, 33426
- University Cancer Institute
-
Boynton Beach, Florida, United States, 33435
- Thomas Niederman, MD
-
New Port Richey, Florida, United States, 34652
- Pasco Hernando Oncology Associates (Kumar)
-
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Georgia
-
Albany, Georgia, United States, 31701
- Phoebe Putney Memorial Hospital
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Atlanta, Georgia, United States, 30318
- Peachtree Hematology-Oncology Consultants
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Atlanta, Georgia, United States, 30331
- Georgia Cancer Specialists
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Dublin, Georgia, United States, 31021
- US Oncology - Dublin Hematology & Oncology
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Hawaii
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Honolulu, Hawaii, United States, 96816
- Straub Clinic and Hospital
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Illinois
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Arlington Heights, Illinois, United States, 60005
- US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Arlington
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Chicago, Illinois, United States, 60612
- John H. Stroger, Jr., Hospital of Cook County
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Harvey, Illinois, United States, 60426
- Ingalls Cancer Research Center
-
Lombard, Illinois, United States, 60148
- Elmhurst Memorial Hospital
-
Niles, Illinois, United States, 60714
- Oncology Specialists, S.C.
-
Niles, Illinois, United States, 60714
- US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Niles
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Peoria, Illinois, United States, 61615
- Illinois Cancer Care
-
Skokie, Illinois, United States, 60076
- Orchard Research
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Urbana, Illinois, United States, 61801
- Carle Cancer Center
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Winfield, Illinois, United States, 60190
- US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Winfield
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Indiana
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Beech Grove, Indiana, United States, 46107
- St. Francis Cancer Research
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Goshen, Indiana, United States, 46526
- Center for Cancer Care @ Goshen Health Systems
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Indianapolis, Indiana, United States, 46202
- Indiana University Cancer Center Clinical Research Office
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Mishawaka, Indiana, United States, 46545
- Cancer Care Partners, LLC
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New Albany, Indiana, United States, 47150
- Cancer Care Center, Inc.
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Iowa
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Ames, Iowa, United States, 50010
- McFarland Clinic
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Bettendorf, Iowa, United States, 52722
- Hematology Oncology Associates of the Quad Cities
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Cedar Rapids, Iowa, United States, 52402
- Iowa Blood and Cancer Care of PCI
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Waterloo, Iowa, United States, 50702
- Covenant Clinic
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Kansas
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Wichita, Kansas, United States, 67214
- Cancer Center of Kansas, PA
-
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Mary Bird Perkins Cancer Center
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Maryland
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Cumberland, Maryland, United States, 21502
- Western Maryland Health System, Inc.
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Westminster, Maryland, United States, 21157
- Alliance Hematology Oncology, PA
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Massachusetts
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Hyannis, Massachusetts, United States, 02601
- Capecod Hospital / Davenport Mugar Cancer Center
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Worcester, Massachusetts, United States, 01608
- Fallon Clinic
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Michigan
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Flint, Michigan, United States, 48532
- Michigan State University / McLaren Regional Medical Center
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Grand Rapids, Michigan, United States, 49503
- Cancer and Hematology Centers of Western Michigan
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Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
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Minnesota
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Duluth, Minnesota, United States, 55805
- Duluth Clinic Cancer Center
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Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Institute Metro - MN CCOP
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Saint Louis Park, Minnesota, United States, 55426
- Park Nicollet Institute - Louisiana Ave.
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Mississippi
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Southaven, Mississippi, United States, 38671
- US Oncology - University of Tennessee Cancer Institute - Southaven
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Missouri
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Columbia, Missouri, United States, 65201
- US Oncology - Missouri Cancer Associates
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Jefferson City, Missouri, United States, 65109
- Capitol Comprehensive Cancer Care Clinic
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Saint Joseph, Missouri, United States, 64507
- St. Joseph Oncology, Inc.
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Saint Louis, Missouri, United States, 63136
- Hematology Oncology Consultants, Inc.
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Springfield, Missouri, United States, 65807
- St. John's Medical Research Institute
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Montana
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Missoula, Montana, United States, 59802
- Montana Cancer Institute Foundation
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Southeast Nebraska Hematology & Oncology Consultants, PC
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Lincoln, Nebraska, United States, 68506
- Nebraska Hematology Oncology, PC
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Nevada
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Las Vegas, Nevada, United States, 89106
- Southern Nevada Cancer Research Foundation
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Reno, Nevada, United States, 89502
- VA Sierra Nevada Healthcare System
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New Jersey
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Cherry Hill, New Jersey, United States, 08003
- The Center for Cancer and Hematologic Disease
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Englewood, New Jersey, United States, 07432
- Drs. Forte, Schleider, Attas & Condemi, PA
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Morristown, New Jersey, United States, 07962
- Charles Farber, MD
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Morristown, New Jersey, United States, 07962
- Hematology Oncology of Northern New Jersey
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Somerville, New Jersey, United States, 08876
- Steeplechase Cancer Center
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New York
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Albany, New York, United States, 12208
- Samuel S Stratton VAMC
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Bay Shore, New York, United States, 11706
- Hematology Oncology Associates of Western Suffolk
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Bronx, New York, United States, 10469
- Eastchester Center for Cancer Care
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Bronx, New York, United States, 10467
- Bronx River Medical Associates
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Bronxville, New York, United States, 10708
- Eduardo Saponara, MD
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Buffalo, New York, United States, 14215
- Jonah Cancer Care Center & ECMC
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Johnson City, New York, United States, 13790
- Broome Oncology
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Syracuse, New York, United States, 14222
- SUNY Upstate Medical University - Adult Program
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North Carolina
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Cary, North Carolina, United States, 27518
- US Oncology - Cancer Centers of North Carolina - Cary
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Raleigh, North Carolina, United States, 27607
- US Oncology - Cancer Centers of North Carolina - Macon
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Raleigh, North Carolina, United States, 27614
- US Oncology - Cancer Centers of North Carolina - Falls
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North Dakota
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Bismarck, North Dakota, United States, 58501
- Legacy Pharma Research
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Fargo, North Dakota, United States, 58122
- Roger Maris Cancer Center
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Ohio
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Akron, Ohio, United States, 44304
- Summa Health System - Cancer Research Office
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Canton, Ohio, United States, 44718
- Gabrail Cancer Center Research
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Columbus, Ohio, United States, 43219
- Mid Ohio Oncology / Hematology, Inc.
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Elyria, Ohio, United States, 44035
- Hematology Oncology Center, Inc.
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Oregon
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Eugene, Oregon, United States, 97401-8122
- US Oncology - Willamette Valley Cancer Institute - Eugene
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Portland, Oregon, United States, 97213-2996
- US Oncology - Northwest Cancer Specialists, PC - Portland - Hoyt
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Portland, Oregon, United States, 97225
- US Oncology - Northwest Cancer Specialists, PC - Portland - Barnes
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Portland, Oregon, United States, 97227
- US Oncology - Northwest Cancer Specialists, PC - Portland - Broadway
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Springfield, Oregon, United States, 97477
- US Oncology - Willamette Valley Cancer Institute - Springfield
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Tualatin, Oregon, United States, 97062
- US Oncology - Northwest Cancer Specialists, PC - Tualatin
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
- Oncology Hematology of Lehigh Valley
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Drexel Hill, Pennsylvania, United States, 19026
- Consultants in Medical Oncology and Hematology, PC
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Gettysburg, Pennsylvania, United States, 17325
- Gettysburg Cancer Center
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Harrisburg, Pennsylvania, United States, 17111
- Andrews and Patel Associates
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Kingston, Pennsylvania, United States, 18704
- US Oncology - Medical Oncology Associates (Nahar)
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Lancaster, Pennsylvania, United States, 17605
- Lancaster Cancer Center
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Reading, Pennsylvania, United States, 19612
- Berks Hematology Oncology Associates
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Rhode Island
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Cranston, Rhode Island, United States, 02920
- Hematology & Oncology Associates of Rhode Island
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South Carolina
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Charleston, South Carolina, United States, 29403
- Charleston Hematology Oncology Associates, PA
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Columbia, South Carolina, United States, 29210
- South Carolina Oncololgy Associates, PA
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Easley, South Carolina, United States, 29640
- US Oncology - Cancer Centers of the Carolinas - Easley
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Greenville, South Carolina, United States, 29605
- US Oncology - Cancer Centers of the Carolinas - Butternut
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Greenville, South Carolina, United States, 29605
- US Oncology - Cancer Centers of the Carolinas - West Faris
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Greenville, South Carolina, United States, 29615
- US Oncology - Cancer Centers of the Carlinas - Eastside
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Seneca, South Carolina, United States, 29672
- US Oncology - Cancer Centers of the Carolinas - Seneca
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Spartanburg, South Carolina, United States, 29307
- US Oncology - Cancer Centers of the Carolinas - Spartanburg
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- Sanford Clinic
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Tennessee
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Bartlett, Tennessee, United States, 38133
- US Oncology - University of Tennessee Cancer Institute - Bartlett
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Collierville, Tennessee, United States, 38017
- Family Cancer Center, PLLC
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Germantown, Tennessee, United States, 38138
- US Oncology - University of Tennessee Cancer Institute - Germantown
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Memphis, Tennessee, United States, 38104
- US Oncology - University of Tennessee Cancer Institute - Memphis
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Nashville, Tennessee, United States, 37203
- SCRI
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Texas
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Abilene, Texas, United States, 79606
- US Oncology - Texas Cancer Center - Abilene (South)
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Amarillo, Texas, United States, 79106
- US Oncology - Texas Oncology, PA - Amarillo
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Arlington, Texas, United States, 76014
- US Oncology - Texas Oncology - Arlington South
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Bedford, Texas, United States, 76022
- US Oncology - Texas Oncology, PA - Bedford
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Bryan, Texas, United States, 77802
- St. Joseph Regional Cancer Center
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College Station, Texas, United States, 77802
- Scott & White Clinic
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Corpus Christi, Texas, United States, 78405
- South Texas Institute of Cancer
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Corpus Christi, Texas, United States, 78463
- Coastal Bend Cancer Center
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Dallas, Texas, United States, 75231
- US Oncology - Texas Oncology, PA - Dallas
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El Paso, Texas, United States, 79902
- US Oncology - El Paso Cancer Treatment Center - West
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El Paso, Texas, United States, 79902
- US Oncology - El Paso Cancer Treatment Center
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Fort Worth, Texas, United States, 76104
- US Oncology - Texas Oncology, PA - Fort Worth
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Fort Worth, Texas, United States, 76132
- US Oncology - Southwest Fort Worth Cancer Center
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Grapevine, Texas, United States, 76051
- US Oncology - Texas Oncology - Grapevine
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Houston, Texas, United States, 77024
- Oncology Consultants
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Kerrville, Texas, United States, 78028
- US Oncology - San Antonio Tumor & Blood Clinic - Kerrville
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Lackland Air Force Base, Texas, United States, 78236
- Wilford Hall Medical Center
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Longview, Texas, United States, 75601
- US Oncology - Longview Cancer Center
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Lubbock, Texas, United States, 79410
- Joe Arrington Cancer Research and Treatment Center
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McAllen, Texas, United States, 78503
- US Oncology - Texas Oncology - McAllen
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Mesquite, Texas, United States, 75150
- US Oncology - Texas Oncology - Mesquite
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Midland, Texas, United States, 79701
- US Oncology - Allison Cancer Center
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Paris, Texas, United States, 75460-5004
- US Oncology - Texas Oncology - Paris
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San Antonio, Texas, United States, 78217
- US Oncology - Cancer Care Centers of South Texas
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San Antonio, Texas, United States, 78258-3912
- US Oncology - San Antonio Tumor & Blood Clinic - M. Oak
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Sherman, Texas, United States, 75090-0504
- US Oncology - Texas Oncology - Sherman
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Temple, Texas, United States, 76508
- Scott & White Healthcare Department of Research
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Tyler, Texas, United States, 75701
- ETMC dba Blood and Cancer Center - East Texas
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Tyler, Texas, United States, 75701
- ETMC dba Tyler Hematology Oncology
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Tyler, Texas, United States, 75702
- US Oncology - Texas Oncology - Tyler
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Waco, Texas, United States, 76712
- US Oncology - Texas Oncology Cancer Care and Research Center
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Weslaco, Texas, United States, 78596
- US Oncology - Texas Oncology - Weslaco
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Wichita Falls, Texas, United States, 76310
- US Oncology - Texoma Cancer Center
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Utah
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American Fork, Utah, United States, 84003
- Central Utah Clinic
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Ogden, Utah, United States, 84403
- Northern Utah Associates
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Virginia
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Arlington, Virginia, United States, 22205
- US Oncology - Arlington Fairfax Hematology Oncology
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Christiansburg, Virginia, United States, 24073
- US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Christiansburg
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Fairfax, Virginia, United States, 22031
- US Oncology - Fairfax Northern VA Hem-Onc PC
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Gainesville, Virginia, United States, 20155
- US Oncology - Fairfax - Northern Virginia Hematology-Oncology, PC - Gainesville
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Leesburg, Virginia, United States, 20176
- US Oncology - Fairfax - Northern Virginia Hem-Onc, PC - Leesburg
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Low Moor, Virginia, United States, 24457
- US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Low Moor
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Roanoke, Virginia, United States, 24014
- US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Roanoke
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Salem, Virginia, United States, 24153
- US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Salem
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Winchester, Virginia, United States, 22601
- US Oncology - Shenandoah Oncology - Winchester
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Woodbridge, Virginia, United States, 22191
- US Oncology - Fairfax - Northern Virginia Hem-Onc, PC - Woodbridge
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Wytheville, Virginia, United States, 24382
- US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Wytheville
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Washington
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Bellingham, Washington, United States, 98226
- Peace Health Medical Group
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Edmonds, Washington, United States, 98133
- US Oncology - Puget Sound Cancer Center - Edmonds
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Everett, Washington, United States, 98201
- Providence Everett Medical Center
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Kennewick, Washington, United States, 99337
- Columbia Basin Hematology and Oncology
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Seattle, Washington, United States, 98133
- US Oncology - Puget Sound Cancer Center - Seattle
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Spokane, Washington, United States, 99208
- Medical Oncology Associates PS
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Spokane, Washington, United States, 99202
- US Oncology - Cancer Care Northwest - Sherman
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Spokane, Washington, United States, 99218
- US Oncology - Cancer Care Northwest - Holland
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Spokane, Washington, United States, 99218
- US Oncology - Cancer Care Northwest - Mission
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Vancouver, Washington, United States, 98684
- US Oncology - Northwest Cancer Specialists, PC - Vancouver - 136th St.
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Vancouver, Washington, United States, 98686
- US Oncology - Northwest Cancer Specialists, PC - Vancouver - 134th St
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Walla Walla, Washington, United States, 99362
- Providence St. Mary Regional Cancer Center
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Yakima, Washington, United States, 98902
- US Oncology - Yakima Valley Memorial Hospital/North Star Lodge (Boyd)
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- St. Vincent Hospital/Green Bay Oncology
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Waukesha, Wisconsin, United States, 53188
- Waukesha Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
An adult population (>=18 years old) of both men and women who have chronic lymphocytic leukemia treated in either community or academic medical centers.
Description
Inclusion Criteria:
- Clinical diagnosis with CLL
- Clinical decision made to initiate first-line therapy, second-line therapy or subsequent line of therapy prior to enrollment into the ConnectTM CLL registry, but within 2 months of enrollment
- Age≥18 years
- Willing and able to provide signed informed consent
- Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from caregivers and/or trained site personnel
Exclusion Criteria:
- Participation in a clinical study in which study treatment is blinded
- Patient condition is considered terminal (i.e.<6 months to live)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify and summarize patterns in therapeutic regimens and patient outcomes
Time Frame: up to 8 years
|
The primary objective is to 1) describe practice patterns of first line therapy regimens and subsequent therapeutic strategies in patients initiated on therapy for CLL, as well as initiated on second line and subsequent therapies, in the community and academic setting (2) Provide insight into therapeutic regimens and therapy sequence in clinical practice as they relate to clinical outcomes in patients initiated on first-line, second-line or subsequent therapies for CLL.
|
up to 8 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Summarize Effectiveness of Treatment Regimens
Time Frame: up to 8 years
|
Describe any differences in effectiveness associated with treatment regimens, including first-line regimens and subsequent therapeutic strategies in patients actively treated for CLL
|
up to 8 years
|
|
Health Related Quality of Life Measures Related to Therapeutic Regimens
Time Frame: up to 8 years
|
Describe the health-related quality of life of patients actively treated for CLL, and to explore the association of HRQoL with therapeutic regimens, sequences and clinical outcomes.
|
up to 8 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kenneth Foon, MD, Celgene Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pashos CL, Flowers CR, Kay NE, Weiss M, Lamanna N, Farber C, Lerner S, Sharman J, Grinblatt D, Flinn IW, Kozloff M, Swern AS, Street TK, Sullivan KA, Harding G, Khan ZM. Association of health-related quality of life with gender in patients with B-cell chronic lymphocytic leukemia. Support Care Cancer. 2013 Oct;21(10):2853-60. doi: 10.1007/s00520-013-1854-z. Epub 2013 Jun 8.
- Mato A, Nabhan C, Kay NE, Weiss MA, Lamanna N, Kipps TJ, Grinblatt DL, Flinn IW, Kozloff MF, Flowers CR, Farber CM, Kiselev P, Swern AS, Sullivan K, Flick ED, Sharman JP. Real-world clinical experience in the Connect(R) chronic lymphocytic leukaemia registry: a prospective cohort study of 1494 patients across 199 US centres. Br J Haematol. 2016 Dec;175(5):892-903. doi: 10.1111/bjh.14332. Epub 2016 Nov 8.
- Nabhan C, Mato A, Flowers CR, Grinblatt DL, Lamanna N, Weiss MA, Davids MS, Swern AS, Bhushan S, Sullivan K, Flick ED, Kiselev P, Sharman JP. Characterizing and prognosticating chronic lymphocytic leukemia in the elderly: prospective evaluation on 455 patients treated in the United States. BMC Cancer. 2017 Mar 16;17(1):198. doi: 10.1186/s12885-017-3176-x.
- Mato A, Nabhan C, Kay NE, Lamanna N, Kipps TJ, Grinblatt DL, Flowers CR, Farber CM, Davids MS, Kiselev P, Swern AS, Bhushan S, Sullivan K, Flick ED, Sharman JP. Prognostic Testing Patterns and Outcomes of Chronic Lymphocytic Leukemia Patients Stratified by Fluorescence In Situ Hybridization/Cytogenetics: A Real-world Clinical Experience in the Connect CLL Registry. Clin Lymphoma Myeloma Leuk. 2018 Feb;18(2):114-124.e2. doi: 10.1016/j.clml.2017.11.010. Epub 2017 Dec 6.
- Ahn IE, Farber CM, Davids MS, Grinblatt DL, Kay NE, Lamanna N, Mato A, Nabhan C, Kiselev P, Swern AS, Flick ED, Sullivan K, Sharman JP, Flowers CR. Early progression of disease as a predictor of survival in chronic lymphocytic leukemia. Blood Adv. 2017 Nov 28;1(25):2433-2443. doi: 10.1182/bloodadvances.2017011262. eCollection 2017 Nov 28.
- Flowers CR, Nabhan C, Kay NE, Mato A, Lamanna N, Farber CM, Davids MS, Kiselev P, Swern AS, Sullivan K, Flick ED, Sharman JP. Reasons for initiation of treatment and predictors of response for patients with Rai stage 0/1 chronic lymphocytic leukemia (CLL) receiving first-line therapy: an analysis of the Connect(R) CLL cohort study. Leuk Lymphoma. 2018 Oct;59(10):2327-2335. doi: 10.1080/10428194.2018.1427860. Epub 2018 Feb 7.
- Mato A, Nabhan C, Lamanna N, Kay NE, Grinblatt DL, Flowers CR, Farber CM, Davids MS, Swern AS, Sullivan K, Flick ED, Gressett Ussery SM, Gharibo M, Kiselev P, Sharman JP. The Connect CLL Registry: final analysis of 1494 patients with chronic lymphocytic leukemia across 199 US sites. Blood Adv. 2020 Apr 14;4(7):1407-1418. doi: 10.1182/bloodadvances.2019001145.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 19, 2010
Primary Completion (ACTUAL)
December 31, 2017
Study Completion (ACTUAL)
December 31, 2017
Study Registration Dates
First Submitted
March 4, 2010
First Submitted That Met QC Criteria
March 4, 2010
First Posted (ESTIMATE)
March 5, 2010
Study Record Updates
Last Update Posted (ACTUAL)
May 12, 2020
Last Update Submitted That Met QC Criteria
May 8, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Connect™ CLL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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