Chronic Lymphocytic LeukemiaNCT01081015
Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
An observational study of Chronic Lymphocytic Leukemia, run by Celgene at 165 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 1,494 participants
- Where
- 165 sitesUnited States
- Study dates
- 19 Mar 2010to 31 Dec 2017
- 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: An adult population (>=18 years old) of both men and women who have chronic lymphocytic leukemia treated in either community or academic medical centers.
Who may be able to join
- 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
Who cannot join
- Participation in a clinical study in which study treatment is blinded
- Patient condition is considered terminal (i.e.<6 months to live)
Trial locations and contacts
165 sites in 1 country.
165 sites in 1 country
United States165 sites
US Oncology - Texas Cancer Center - Abilene (South)
Abilene, Texas, 79606
Summa Health System - Cancer Research Office
Akron, Ohio, 44304
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
Samuel S Stratton VAMC
Albany, New York, 12208
US Oncology - Texas Oncology, PA - Amarillo
Amarillo, Texas, 79106
Central Utah Clinic
American Fork, Utah, 84003
McFarland Clinic
Ames, Iowa, 50010
US Oncology - Texas Oncology - Arlington South
Arlington, Texas, 76014
US Oncology - Arlington Fairfax Hematology Oncology
Arlington, Virginia, 22205
US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Arlington
Arlington Heights, Illinois, 60005
Peachtree Hematology-Oncology Consultants
Atlanta, Georgia, 30318
Georgia Cancer Specialists
Atlanta, Georgia, 30331
Medical Specialists of the Palm Beaches
Atlantis, Florida, 33462
US Oncology - University of Tennessee Cancer Institute - Bartlett
Bartlett, Tennessee, 38133
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Hematology Oncology Associates of Western Suffolk
Bay Shore, New York, 11706
US Oncology - Texas Oncology, PA - Bedford
Bedford, Texas, 76022
St. Francis Cancer Research
Beech Grove, Indiana, 46107
Peace Health Medical Group
Bellingham, Washington, 98226
Oncology Hematology of Lehigh Valley
Bethlehem, Pennsylvania, 18015
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
Legacy Pharma Research
Bismarck, North Dakota, 58501
University Cancer Institute
Boynton Beach, Florida, 33426
Thomas Niederman, MD
Boynton Beach, Florida, 33435
Eduardo Saponara, MD
Bronxville, New York, 10708
St. Joseph Regional Cancer Center
Bryan, Texas, 77802
Jonah Cancer Care Center & ECMC
Buffalo, New York, 14215
Gabrail Cancer Center Research
Canton, Ohio, 44718
US Oncology - Cancer Centers of North Carolina - Cary
Cary, North Carolina, 27518
Iowa Blood and Cancer Care of PCI
Cedar Rapids, Iowa, 52402
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29403
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003
John H. Stroger, Jr., Hospital of Cook County
Chicago, Illinois, 60612
Rush University Medical Center
Chicago, Illinois, 60612
US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Christiansburg
Christiansburg, Virginia, 24073
Scott & White Clinic
College Station, Texas, 77802
Family Cancer Center, PLLC
Collierville, Tennessee, 38017
US Oncology - Missouri Cancer Associates
Columbia, Missouri, 65201
South Carolina Oncololgy Associates, PA
Columbia, South Carolina, 29210
Mid Ohio Oncology / Hematology, Inc.
Columbus, Ohio, 43219
South Texas Institute of Cancer
Corpus Christi, Texas, 78405
Coastal Bend Cancer Center
Corpus Christi, Texas, 78463
Hematology & Oncology Associates of Rhode Island
Cranston, Rhode Island, 02920
Western Maryland Health System, Inc.
Cumberland, Maryland, 21502
US Oncology - Texas Oncology, PA - Dallas
Dallas, Texas, 75231
Consultants in Medical Oncology and Hematology, PC
Drexel Hill, Pennsylvania, 19026
US Oncology - Dublin Hematology & Oncology
Dublin, Georgia, 31021
Duluth Clinic Cancer Center
Duluth, Minnesota, 55805
US Oncology - Cancer Centers of the Carolinas - Easley
Easley, South Carolina, 29640
US Oncology - Puget Sound Cancer Center - Edmonds
Edmonds, Washington, 98133
US Oncology - El Paso Cancer Treatment Center - West
El Paso, Texas, 79902
US Oncology - El Paso Cancer Treatment Center
El Paso, Texas, 79902
Hematology Oncology Center, Inc.
Elyria, Ohio, 44035
Drs. Forte, Schleider, Attas & Condemi, PA
Englewood, New Jersey, 07432
US Oncology - Willamette Valley Cancer Institute - Eugene
Eugene, Oregon, 97401-8122
Providence Everett Medical Center
Everett, Washington, 98201
US Oncology - Fairfax Northern VA Hem-Onc PC
Fairfax, Virginia, 22031
Roger Maris Cancer Center
Fargo, North Dakota, 58122
Michigan State University / McLaren Regional Medical Center
Flint, Michigan, 48532
US Oncology - Texas Oncology, PA - Fort Worth
Fort Worth, Texas, 76104
US Oncology - Southwest Fort Worth Cancer Center
Fort Worth, Texas, 76132
US Oncology - Fairfax - Northern Virginia Hematology-Oncology, PC - Gainesville
Gainesville, Virginia, 20155
US Oncology - University of Tennessee Cancer Institute - Germantown
Germantown, Tennessee, 38138
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Center for Cancer Care @ Goshen Health Systems
Goshen, Indiana, 46526
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
US Oncology - Texas Oncology - Grapevine
Grapevine, Texas, 76051
St. Vincent Hospital/Green Bay Oncology
Green Bay, Wisconsin, 54301
US Oncology - Cancer Centers of the Carolinas - Butternut
Greenville, South Carolina, 29605
US Oncology - Cancer Centers of the Carolinas - West Faris
Greenville, South Carolina, 29605
US Oncology - Cancer Centers of the Carlinas - Eastside
Greenville, South Carolina, 29615
Andrews and Patel Associates
Harrisburg, Pennsylvania, 17111
Ingalls Cancer Research Center
Harvey, Illinois, 60426
Straub Clinic and Hospital
Honolulu, Hawaii, 96816
Oncology Consultants
Houston, Texas, 77024
MD Anderson Cancer Center
Houston, Texas, 77030
Capecod Hospital / Davenport Mugar Cancer Center
Hyannis, Massachusetts, 02601
Indiana University Cancer Center Clinical Research Office
Indianapolis, Indiana, 46202
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109
Broome Oncology
Johnson City, New York, 13790
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Columbia Basin Hematology and Oncology
Kennewick, Washington, 99337
US Oncology - San Antonio Tumor & Blood Clinic - Kerrville
Kerrville, Texas, 78028
US Oncology - Medical Oncology Associates (Nahar)
Kingston, Pennsylvania, 18704
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236
Lancaster Cancer Center
Lancaster, Pennsylvania, 17605
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
US Oncology - Fairfax - Northern Virginia Hem-Onc, PC - Leesburg
Leesburg, Virginia, 20176
Nebraska Hematology Oncology, PC
Lincoln, Nebraska, 68506
Southeast Nebraska Hematology & Oncology Consultants, PC
Lincoln, Nebraska, 68510
Elmhurst Memorial Hospital
Lombard, Illinois, 60148
US Oncology - Longview Cancer Center
Longview, Texas, 75601
US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Low Moor
Low Moor, Virginia, 24457
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
US Oncology - Texas Oncology - McAllen
McAllen, Texas, 78503
US Oncology - University of Tennessee Cancer Institute - Memphis
Memphis, Tennessee, 38104
US Oncology - Texas Oncology - Mesquite
Mesquite, Texas, 75150
US Oncology - Allison Cancer Center
Midland, Texas, 79701
Cancer Care Partners, LLC
Mishawaka, Indiana, 46545
Montana Cancer Institute Foundation
Missoula, Montana, 59802
Charles Farber, MD
Morristown, New Jersey, 07962
Hematology Oncology of Northern New Jersey
Morristown, New Jersey, 07962
SCRI
Nashville, Tennessee, 37203
Cancer Care Center, Inc.
New Albany, Indiana, 47150
Pasco Hernando Oncology Associates (Kumar)
New Port Richey, Florida, 34652
Oncology Specialists, S.C.
Niles, Illinois, 60714
US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Niles
Niles, Illinois, 60714
Northern Utah Associates
Ogden, Utah, 84403
US Oncology - Texas Oncology - Paris
Paris, Texas, 75460-5004
Illinois Cancer Care
Peoria, Illinois, 61615
New Hope Cancer & Research Institute
Pomona, California, 91767
US Oncology - Northwest Cancer Specialists, PC - Portland - Hoyt
Portland, Oregon, 97213-2996
US Oncology - Northwest Cancer Specialists, PC - Portland - Barnes
Portland, Oregon, 97225
US Oncology - Northwest Cancer Specialists, PC - Portland - Broadway
Portland, Oregon, 97227
US Oncology - Cancer Centers of North Carolina - Macon
Raleigh, North Carolina, 27607
US Oncology - Cancer Centers of North Carolina - Falls
Raleigh, North Carolina, 27614
Berks Hematology Oncology Associates
Reading, Pennsylvania, 19612
VA Sierra Nevada Healthcare System
Reno, Nevada, 89502
US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Roanoke
Roanoke, Virginia, 24014
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, 64507
Park Nicollet Institute Metro - MN CCOP
Saint Louis Park, Minnesota, 55416
Park Nicollet Institute - Louisiana Ave.
Saint Louis Park, Minnesota, 55426
US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Salem
Salem, Virginia, 24153
US Oncology - Cancer Care Centers of South Texas
San Antonio, Texas, 78217
US Oncology - San Antonio Tumor & Blood Clinic - M. Oak
San Antonio, Texas, 78258-3912
US Oncology - Puget Sound Cancer Center - Seattle
Seattle, Washington, 98133
US Oncology - Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, 29672
US Oncology - Texas Oncology - Sherman
Sherman, Texas, 75090-0504
Sanford Clinic
Sioux Falls, South Dakota, 57104
Orchard Research
Skokie, Illinois, 60076
Steeplechase Cancer Center
Somerville, New Jersey, 08876
US Oncology - University of Tennessee Cancer Institute - Southaven
Southaven, Mississippi, 38671
US Oncology - Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, 29307
US Oncology - Cancer Care Northwest - Sherman
Spokane, Washington, 99202
Medical Oncology Associates PS
Spokane, Washington, 99208
US Oncology - Cancer Care Northwest - Holland
Spokane, Washington, 99218
US Oncology - Cancer Care Northwest - Mission
Spokane, Washington, 99218
St. John's Medical Research Institute
Springfield, Missouri, 65807
US Oncology - Willamette Valley Cancer Institute - Springfield
Springfield, Oregon, 97477
Hematology Oncology Consultants, Inc.
St Louis, Missouri, 63136
SUNY Upstate Medical University - Adult Program
Syracuse, New York, 14222
Scott & White Healthcare Department of Research
Temple, Texas, 76508
Bronx River Medical Associates
The Bronx, New York, 10467
Eastchester Center for Cancer Care
The Bronx, New York, 10469
US Oncology - Northwest Cancer Specialists, PC - Tualatin
Tualatin, Oregon, 97062
ETMC dba Blood and Cancer Center - East Texas
Tyler, Texas, 75701
ETMC dba Tyler Hematology Oncology
Tyler, Texas, 75701
US Oncology - Texas Oncology - Tyler
Tyler, Texas, 75702
Carle Cancer Center
Urbana, Illinois, 61801
US Oncology - Northwest Cancer Specialists, PC - Vancouver - 136th St.
Vancouver, Washington, 98684
US Oncology - Northwest Cancer Specialists, PC - Vancouver - 134th St
Vancouver, Washington, 98686
US Oncology - Texas Oncology Cancer Care and Research Center
Waco, Texas, 76712
Providence St. Mary Regional Cancer Center
Walla Walla, Washington, 99362
Covenant Clinic
Waterloo, Iowa, 50702
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
US Oncology - Texas Oncology - Weslaco
Weslaco, Texas, 78596
Alliance Hematology Oncology, PA
Westminster, Maryland, 21157
Cancer Center of Kansas, PA
Wichita, Kansas, 67214
US Oncology - Texoma Cancer Center
Wichita Falls, Texas, 76310
US Oncology - Shenandoah Oncology - Winchester
Winchester, Virginia, 22601
US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Winfield
Winfield, Illinois, 60190
US Oncology - Fairfax - Northern Virginia Hem-Onc, PC - Woodbridge
Woodbridge, Virginia, 22191
Fallon Clinic
Worcester, Massachusetts, 01608
US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Wytheville
Wytheville, Virginia, 24382
US Oncology - Yakima Valley Memorial Hospital/North Star Lodge (Boyd)
Yakima, Washington, 98902
About this study
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.
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, CLL, disease registry, Connect™
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify and summarize patterns in therapeutic regimens and patient outcomes
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.
Measured: up to 8 years
Secondary outcomes (2)
Summarize Effectiveness of Treatment Regimens
Describe any differences in effectiveness associated with treatment regimens, including first-line regimens and subsequent therapeutic strategies in patients actively treated for CLL
Measured: up to 8 years
Health Related Quality of Life Measures Related to Therapeutic Regimens
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.
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study start19 Mar 2010
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 1,494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Foon, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081015
- Sponsor's protocol ID
- Connect™ CLL
- Status last verified
- May 2020
- First submitted
- 4 Mar 2010
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23748484Mato 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.
PubMed 27861736Nabhan 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.
PubMed 28302090Mato 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.
PubMed 29352719Ahn 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.
PubMed 29296893Flowers 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.
PubMed 29415595Mato 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.
PubMed 32271900
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
- ClinicalTrials.gov ID
- NCT01081015
- Acronym / sponsor ID
- Connect™ CLL
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, CLL, disease registry, Connect™
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,494 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2010 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Participation in a clinical study in which study treatment is blinded
- Patient condition is considered terminal (i.e.<6 months to live)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Summarize Effectiveness of Treatment Regimens
Time frame: up to 8 years
Health Related Quality of Life Measures Related to Therapeutic Regimens
Time frame: up to 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Results publication: PubMed 23748484Pashos 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.
- Results publication: PubMed 27861736Mato 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.
- Results publication: PubMed 28302090Nabhan 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.
- Results publication: PubMed 29352719Mato 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.
- Results publication: PubMed 29296893Ahn 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.
- Results publication: PubMed 29415595Flowers 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.
- Derived from this study: PubMed 32271900Mato 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Foon, MD study director
Celgene Corporation
165 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by Celgene at 165 sites in United States.
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 5 inclusion and 2 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 165 sites in United States. 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?
Identify and summarize patterns in therapeutic regimens and patient outcomes (time frame: up to 8 years). 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 NCT01081015, which also lists 7 linked publications.
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 12 May 2020.