Clinical trial NCT01081015: Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
Official title: Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
CLL
disease registry
Connect™
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 1494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Identify and summarize patterns in therapeutic regimens and patient outcomes
timeFrame: up to 8 years
Secondary outcomes:
measure: Summarize Effectiveness of Treatment Regimens
timeFrame: up to 8 years
measure: Health Related Quality of Life Measures Related to Therapeutic Regimens
timeFrame: up to 8 years
Other outcomes:
Locations:
city: Pomona
country: United States
facility: New Hope Cancer & Research Institute
state: California
city: Atlantis
country: United States
facility: Medical Specialists of the Palm Beaches
state: Florida
city: Boynton Beach
country: United States
facility: University Cancer Institute
state: Florida
city: Boynton Beach
country: United States
facility: Thomas Niederman, MD
state: Florida
city: New Port Richey
country: United States
facility: Pasco Hernando Oncology Associates (Kumar)
state: Florida
city: Albany
country: United States
facility: Phoebe Putney Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Peachtree Hematology-Oncology Consultants
state: Georgia
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Dublin
country: United States
facility: US Oncology - Dublin Hematology & Oncology
state: Georgia
city: Honolulu
country: United States
facility: Straub Clinic and Hospital
state: Hawaii
city: Arlington Heights
country: United States
facility: US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Arlington
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger, Jr., Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Harvey
country: United States
facility: Ingalls Cancer Research Center
state: Illinois
city: Lombard
country: United States
facility: Elmhurst Memorial Hospital
state: Illinois
city: Niles
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Niles
country: United States
facility: US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Niles
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Skokie
country: United States
facility: Orchard Research
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Winfield
country: United States
facility: US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Winfield
state: Illinois
city: Beech Grove
country: United States
facility: St. Francis Cancer Research
state: Indiana
city: Goshen
country: United States
facility: Center for Cancer Care @ Goshen Health Systems
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Cancer Center Clinical Research Office
state: Indiana
city: Mishawaka
country: United States
facility: Cancer Care Partners, LLC
state: Indiana
city: New Albany
country: United States
facility: Cancer Care Center, Inc.
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic
state: Iowa
city: Bettendorf
country: United States
facility: Hematology Oncology Associates of the Quad Cities
state: Iowa
city: Cedar Rapids
country: United States
facility: Iowa Blood and Cancer Care of PCI
state: Iowa
city: Waterloo
country: United States
facility: Covenant Clinic
state: Iowa
city: Wichita
country: United States
facility: Cancer Center of Kansas, PA
state: Kansas
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Cumberland
country: United States
facility: Western Maryland Health System, Inc.
state: Maryland
city: Westminster
country: United States
facility: Alliance Hematology Oncology, PA
state: Maryland
city: Hyannis
country: United States
facility: Capecod Hospital / Davenport Mugar Cancer Center
state: Massachusetts
city: Worcester
country: United States
facility: Fallon Clinic
state: Massachusetts
city: Flint
country: United States
facility: Michigan State University / McLaren Regional Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Duluth
country: United States
facility: Duluth Clinic Cancer Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Institute Metro - MN CCOP
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Institute - Louisiana Ave.
state: Minnesota
city: Southaven
country: United States
facility: US Oncology - University of Tennessee Cancer Institute - Southaven
state: Mississippi
city: Columbia
country: United States
facility: US Oncology - Missouri Cancer Associates
state: Missouri
city: Jefferson City
country: United States
facility: Capitol Comprehensive Cancer Care Clinic
state: Missouri
city: Saint Joseph
country: United States
facility: St. Joseph Oncology, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Missouri
city: Springfield
country: United States
facility: St. John's Medical Research Institute
state: Missouri
city: Missoula
country: United States
facility: Montana Cancer Institute Foundation
state: Montana
city: Lincoln
country: United States
facility: Nebraska Hematology Oncology, PC
state: Nebraska
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology & Oncology Consultants, PC
state: Nebraska
city: Las Vegas
country: United States
facility: Southern Nevada Cancer Research Foundation
state: Nevada
city: Reno
country: United States
facility: VA Sierra Nevada Healthcare System
state: Nevada
city: Cherry Hill
country: United States
facility: The Center for Cancer and Hematologic Disease
state: New Jersey
city: Englewood
country: United States
facility: Drs. Forte, Schleider, Attas & Condemi, PA
state: New Jersey
city: Morristown
country: United States
facility: Charles Farber, MD
state: New Jersey
city: Morristown
country: United States
facility: Hematology Oncology of Northern New Jersey
state: New Jersey
city: Somerville
country: United States
facility: Steeplechase Cancer Center
state: New Jersey
city: Albany
country: United States
facility: Samuel S Stratton VAMC
state: New York
city: Bay Shore
country: United States
facility: Hematology Oncology Associates of Western Suffolk
state: New York
city: Bronxville
country: United States
facility: Eduardo Saponara, MD
state: New York
city: Bronx
country: United States
facility: Bronx River Medical Associates
state: New York
city: Bronx
country: United States
facility: Eastchester Center for Cancer Care
state: New York
city: Buffalo
country: United States
facility: Jonah Cancer Care Center & ECMC
state: New York
city: Johnson City
country: United States
facility: Broome Oncology
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University - Adult Program
state: New York
city: Cary
country: United States
facility: US Oncology - Cancer Centers of North Carolina - Cary
state: North Carolina
city: Raleigh
country: United States
facility: US Oncology - Cancer Centers of North Carolina - Macon
state: North Carolina
city: Raleigh
country: United States
facility: US Oncology - Cancer Centers of North Carolina - Falls
state: North Carolina
city: Bismarck
country: United States
facility: Legacy Pharma Research
state: North Dakota
city: Fargo
country: United States
facility: Roger Maris Cancer Center
state: North Dakota
city: Akron
country: United States
facility: Summa Health System - Cancer Research Office
state: Ohio
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Oncology / Hematology, Inc.
state: Ohio
city: Elyria
country: United States
facility: Hematology Oncology Center, Inc.
state: Ohio
city: Eugene
country: United States
facility: US Oncology - Willamette Valley Cancer Institute - Eugene
state: Oregon
city: Portland
country: United States
facility: US Oncology - Northwest Cancer Specialists, PC - Portland - Hoyt
state: Oregon
city: Portland
country: United States
facility: US Oncology - Northwest Cancer Specialists, PC - Portland - Barnes
state: Oregon
city: Portland
country: United States
facility: US Oncology - Northwest Cancer Specialists, PC - Portland - Broadway
state: Oregon
city: Springfield
country: United States
facility: US Oncology - Willamette Valley Cancer Institute - Springfield
state: Oregon
city: Tualatin
country: United States
facility: US Oncology - Northwest Cancer Specialists, PC - Tualatin
state: Oregon
city: Bethlehem
country: United States
facility: Oncology Hematology of Lehigh Valley
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Consultants in Medical Oncology and Hematology, PC
state: Pennsylvania
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Andrews and Patel Associates
state: Pennsylvania
city: Kingston
country: United States
facility: US Oncology - Medical Oncology Associates (Nahar)
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Cancer Center
state: Pennsylvania
city: Reading
country: United States
facility: Berks Hematology Oncology Associates
state: Pennsylvania
city: Cranston
country: United States
facility: Hematology & Oncology Associates of Rhode Island
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, PA
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncololgy Associates, PA
state: South Carolina
city: Easley
country: United States
facility: US Oncology - Cancer Centers of the Carolinas - Easley
state: South Carolina
city: Greenville
country: United States
facility: US Oncology - Cancer Centers of the Carolinas - Butternut
state: South Carolina
city: Greenville
country: United States
facility: US Oncology - Cancer Centers of the Carolinas - West Faris
state: South Carolina
city: Greenville
country: United States
facility: US Oncology - Cancer Centers of the Carlinas - Eastside
state: South Carolina
city: Seneca
country: United States
facility: US Oncology - Cancer Centers of the Carolinas - Seneca
state: South Carolina
city: Spartanburg
country: United States
facility: US Oncology - Cancer Centers of the Carolinas - Spartanburg
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Clinic
state: South Dakota
city: Bartlett
country: United States
facility: US Oncology - University of Tennessee Cancer Institute - Bartlett
state: Tennessee
city: Collierville
country: United States
facility: Family Cancer Center, PLLC
state: Tennessee
city: Germantown
country: United States
facility: US Oncology - University of Tennessee Cancer Institute - Germantown
state: Tennessee
city: Memphis
country: United States
facility: US Oncology - University of Tennessee Cancer Institute - Memphis
state: Tennessee
city: Nashville
country: United States
facility: SCRI
state: Tennessee
city: Abilene
country: United States
facility: US Oncology - Texas Cancer Center - Abilene (South)
state: Texas
city: Amarillo
country: United States
facility: US Oncology - Texas Oncology, PA - Amarillo
state: Texas
city: Arlington
country: United States
facility: US Oncology - Texas Oncology - Arlington South
state: Texas
city: Bedford
country: United States
facility: US Oncology - Texas Oncology, PA - Bedford
state: Texas
city: Bryan
country: United States
facility: St. Joseph Regional Cancer Center
state: Texas
city: College Station
country: United States
facility: Scott & White Clinic
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Institute of Cancer
state: Texas
city: Corpus Christi
country: United States
facility: Coastal Bend Cancer Center
state: Texas
city: Dallas
country: United States
facility: US Oncology - Texas Oncology, PA - Dallas
state: Texas
city: El Paso
country: United States
facility: US Oncology - El Paso Cancer Treatment Center - West
state: Texas
city: El Paso
country: United States
facility: US Oncology - El Paso Cancer Treatment Center
state: Texas
city: Fort Worth
country: United States
facility: US Oncology - Texas Oncology, PA - Fort Worth
state: Texas
city: Fort Worth
country: United States
facility: US Oncology - Southwest Fort Worth Cancer Center
state: Texas
city: Grapevine
country: United States
facility: US Oncology - Texas Oncology - Grapevine
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Kerrville
country: United States
facility: US Oncology - San Antonio Tumor & Blood Clinic - Kerrville
state: Texas
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Medical Center
state: Texas
city: Longview
country: United States
facility: US Oncology - Longview Cancer Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: McAllen
country: United States
facility: US Oncology - Texas Oncology - McAllen
state: Texas
city: Mesquite
country: United States
facility: US Oncology - Texas Oncology - Mesquite
state: Texas
city: Midland
country: United States
facility: US Oncology - Allison Cancer Center
state: Texas
city: Paris
country: United States
facility: US Oncology - Texas Oncology - Paris
state: Texas
city: San Antonio
country: United States
facility: US Oncology - Cancer Care Centers of South Texas
state: Texas
city: San Antonio
country: United States
facility: US Oncology - San Antonio Tumor & Blood Clinic - M. Oak
state: Texas
city: Sherman
country: United States
facility: US Oncology - Texas Oncology - Sherman
state: Texas
city: Temple
country: United States
facility: Scott & White Healthcare Department of Research
state: Texas
city: Tyler
country: United States
facility: ETMC dba Blood and Cancer Center - East Texas
state: Texas
city: Tyler
country: United States
facility: ETMC dba Tyler Hematology Oncology
state: Texas
city: Tyler
country: United States
facility: US Oncology - Texas Oncology - Tyler
state: Texas
city: Waco
country: United States
facility: US Oncology - Texas Oncology Cancer Care and Research Center
state: Texas
city: Weslaco
country: United States
facility: US Oncology - Texas Oncology - Weslaco
state: Texas
city: Wichita Falls
country: United States
facility: US Oncology - Texoma Cancer Center
state: Texas
city: American Fork
country: United States
facility: Central Utah Clinic
state: Utah
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Arlington
country: United States
facility: US Oncology - Arlington Fairfax Hematology Oncology
state: Virginia
city: Christiansburg
country: United States
facility: US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Christiansburg
state: Virginia
city: Fairfax
country: United States
facility: US Oncology - Fairfax Northern VA Hem-Onc PC
state: Virginia
city: Gainesville
country: United States
facility: US Oncology - Fairfax - Northern Virginia Hematology-Oncology, PC - Gainesville
state: Virginia
city: Leesburg
country: United States
facility: US Oncology - Fairfax - Northern Virginia Hem-Onc, PC - Leesburg
state: Virginia
city: Low Moor
country: United States
facility: US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Low Moor
state: Virginia
city: Roanoke
country: United States
facility: US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Roanoke
state: Virginia
city: Salem
country: United States
facility: US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Salem
state: Virginia
city: Winchester
country: United States
facility: US Oncology - Shenandoah Oncology - Winchester
state: Virginia
city: Woodbridge
country: United States
facility: US Oncology - Fairfax - Northern Virginia Hem-Onc, PC - Woodbridge
state: Virginia
city: Wytheville
country: United States
facility: US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Wytheville
state: Virginia
city: Bellingham
country: United States
facility: Peace Health Medical Group
state: Washington
city: Edmonds
country: United States
facility: US Oncology - Puget Sound Cancer Center - Edmonds
state: Washington
city: Everett
country: United States
facility: Providence Everett Medical Center
state: Washington
city: Kennewick
country: United States
facility: Columbia Basin Hematology and Oncology
state: Washington
city: Seattle
country: United States
facility: US Oncology - Puget Sound Cancer Center - Seattle
state: Washington
city: Spokane
country: United States
facility: US Oncology - Cancer Care Northwest - Sherman
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates PS
state: Washington
city: Spokane
country: United States
facility: US Oncology - Cancer Care Northwest - Holland
state: Washington
city: Spokane
country: United States
facility: US Oncology - Cancer Care Northwest - Mission
state: Washington
city: Vancouver
country: United States
facility: US Oncology - Northwest Cancer Specialists, PC - Vancouver - 136th St.
state: Washington
city: Vancouver
country: United States
facility: US Oncology - Northwest Cancer Specialists, PC - Vancouver - 134th St
state: Washington
city: Walla Walla
country: United States
facility: Providence St. Mary Regional Cancer Center
state: Washington
city: Yakima
country: United States
facility: US Oncology - Yakima Valley Memorial Hospital/North Star Lodge (Boyd)
state: Washington
city: Green Bay
country: United States
facility: St. Vincent Hospital/Green Bay Oncology
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
Study officials:
affiliation: Celgene Corporation
name: Kenneth Foon, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.