Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Connect™ CLL: The Chronic Lymphocytic Leukemia Disease Registry
| Verified date | May 2020 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1494 |
| Est. completion date | December 31, 2017 |
| Est. primary completion date | December 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | US Oncology - Texas Cancer Center - Abilene (South) | Abilene | Texas |
| United States | Summa Health System - Cancer Research Office | Akron | Ohio |
| United States | Phoebe Putney Memorial Hospital | Albany | Georgia |
| United States | Samuel S Stratton VAMC | Albany | New York |
| United States | US Oncology - Texas Oncology, PA - Amarillo | Amarillo | Texas |
| United States | Central Utah Clinic | American Fork | Utah |
| United States | McFarland Clinic | Ames | Iowa |
| United States | US Oncology - Arlington Fairfax Hematology Oncology | Arlington | Virginia |
| United States | US Oncology - Texas Oncology - Arlington South | Arlington | Texas |
| United States | US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Arlington | Arlington Heights | Illinois |
| United States | Georgia Cancer Specialists | Atlanta | Georgia |
| United States | Peachtree Hematology-Oncology Consultants | Atlanta | Georgia |
| United States | Medical Specialists of the Palm Beaches | Atlantis | Florida |
| United States | US Oncology - University of Tennessee Cancer Institute - Bartlett | Bartlett | Tennessee |
| United States | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana |
| United States | Hematology Oncology Associates of Western Suffolk | Bay Shore | New York |
| United States | US Oncology - Texas Oncology, PA - Bedford | Bedford | Texas |
| United States | St. Francis Cancer Research | Beech Grove | Indiana |
| United States | Peace Health Medical Group | Bellingham | Washington |
| United States | Oncology Hematology of Lehigh Valley | Bethlehem | Pennsylvania |
| United States | Hematology Oncology Associates of the Quad Cities | Bettendorf | Iowa |
| United States | Legacy Pharma Research | Bismarck | North Dakota |
| United States | Thomas Niederman, MD | Boynton Beach | Florida |
| United States | University Cancer Institute | Boynton Beach | Florida |
| United States | Bronx River Medical Associates | Bronx | New York |
| United States | Eastchester Center for Cancer Care | Bronx | New York |
| United States | Eduardo Saponara, MD | Bronxville | New York |
| United States | St. Joseph Regional Cancer Center | Bryan | Texas |
| United States | Jonah Cancer Care Center & ECMC | Buffalo | New York |
| United States | Gabrail Cancer Center Research | Canton | Ohio |
| United States | US Oncology - Cancer Centers of North Carolina - Cary | Cary | North Carolina |
| United States | Iowa Blood and Cancer Care of PCI | Cedar Rapids | Iowa |
| United States | Charleston Hematology Oncology Associates, PA | Charleston | South Carolina |
| United States | The Center for Cancer and Hematologic Disease | Cherry Hill | New Jersey |
| United States | John H. Stroger, Jr., Hospital of Cook County | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Christiansburg | Christiansburg | Virginia |
| United States | Scott & White Clinic | College Station | Texas |
| United States | Family Cancer Center, PLLC | Collierville | Tennessee |
| United States | South Carolina Oncololgy Associates, PA | Columbia | South Carolina |
| United States | US Oncology - Missouri Cancer Associates | Columbia | Missouri |
| United States | Mid Ohio Oncology / Hematology, Inc. | Columbus | Ohio |
| United States | Coastal Bend Cancer Center | Corpus Christi | Texas |
| United States | South Texas Institute of Cancer | Corpus Christi | Texas |
| United States | Hematology & Oncology Associates of Rhode Island | Cranston | Rhode Island |
| United States | Western Maryland Health System, Inc. | Cumberland | Maryland |
| United States | US Oncology - Texas Oncology, PA - Dallas | Dallas | Texas |
| United States | Consultants in Medical Oncology and Hematology, PC | Drexel Hill | Pennsylvania |
| United States | US Oncology - Dublin Hematology & Oncology | Dublin | Georgia |
| United States | Duluth Clinic Cancer Center | Duluth | Minnesota |
| United States | US Oncology - Cancer Centers of the Carolinas - Easley | Easley | South Carolina |
| United States | US Oncology - Puget Sound Cancer Center - Edmonds | Edmonds | Washington |
| United States | US Oncology - El Paso Cancer Treatment Center | El Paso | Texas |
| United States | US Oncology - El Paso Cancer Treatment Center - West | El Paso | Texas |
| United States | Hematology Oncology Center, Inc. | Elyria | Ohio |
| United States | Drs. Forte, Schleider, Attas & Condemi, PA | Englewood | New Jersey |
| United States | US Oncology - Willamette Valley Cancer Institute - Eugene | Eugene | Oregon |
| United States | Providence Everett Medical Center | Everett | Washington |
| United States | US Oncology - Fairfax Northern VA Hem-Onc PC | Fairfax | Virginia |
| United States | Roger Maris Cancer Center | Fargo | North Dakota |
| United States | Michigan State University / McLaren Regional Medical Center | Flint | Michigan |
| United States | US Oncology - Southwest Fort Worth Cancer Center | Fort Worth | Texas |
| United States | US Oncology - Texas Oncology, PA - Fort Worth | Fort Worth | Texas |
| United States | US Oncology - Fairfax - Northern Virginia Hematology-Oncology, PC - Gainesville | Gainesville | Virginia |
| United States | US Oncology - University of Tennessee Cancer Institute - Germantown | Germantown | Tennessee |
| United States | Gettysburg Cancer Center | Gettysburg | Pennsylvania |
| United States | Center for Cancer Care @ Goshen Health Systems | Goshen | Indiana |
| United States | Cancer and Hematology Centers of Western Michigan | Grand Rapids | Michigan |
| United States | US Oncology - Texas Oncology - Grapevine | Grapevine | Texas |
| United States | St. Vincent Hospital/Green Bay Oncology | Green Bay | Wisconsin |
| United States | US Oncology - Cancer Centers of the Carlinas - Eastside | Greenville | South Carolina |
| United States | US Oncology - Cancer Centers of the Carolinas - Butternut | Greenville | South Carolina |
| United States | US Oncology - Cancer Centers of the Carolinas - West Faris | Greenville | South Carolina |
| United States | Andrews and Patel Associates | Harrisburg | Pennsylvania |
| United States | Ingalls Cancer Research Center | Harvey | Illinois |
| United States | Straub Clinic and Hospital | Honolulu | Hawaii |
| United States | MD Anderson Cancer Center | Houston | Texas |
| United States | Oncology Consultants | Houston | Texas |
| United States | Capecod Hospital / Davenport Mugar Cancer Center | Hyannis | Massachusetts |
| United States | Indiana University Cancer Center Clinical Research Office | Indianapolis | Indiana |
| United States | Capitol Comprehensive Cancer Care Clinic | Jefferson City | Missouri |
| United States | Broome Oncology | Johnson City | New York |
| United States | West Michigan Cancer Center | Kalamazoo | Michigan |
| United States | Columbia Basin Hematology and Oncology | Kennewick | Washington |
| United States | US Oncology - San Antonio Tumor & Blood Clinic - Kerrville | Kerrville | Texas |
| United States | US Oncology - Medical Oncology Associates (Nahar) | Kingston | Pennsylvania |
| United States | Wilford Hall Medical Center | Lackland Air Force Base | Texas |
| United States | Lancaster Cancer Center | Lancaster | Pennsylvania |
| United States | Southern Nevada Cancer Research Foundation | Las Vegas | Nevada |
| United States | US Oncology - Fairfax - Northern Virginia Hem-Onc, PC - Leesburg | Leesburg | Virginia |
| United States | Nebraska Hematology Oncology, PC | Lincoln | Nebraska |
| United States | Southeast Nebraska Hematology & Oncology Consultants, PC | Lincoln | Nebraska |
| United States | Elmhurst Memorial Hospital | Lombard | Illinois |
| United States | US Oncology - Longview Cancer Center | Longview | Texas |
| United States | US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Low Moor | Low Moor | Virginia |
| United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
| United States | US Oncology - Texas Oncology - McAllen | McAllen | Texas |
| United States | US Oncology - University of Tennessee Cancer Institute - Memphis | Memphis | Tennessee |
| United States | US Oncology - Texas Oncology - Mesquite | Mesquite | Texas |
| United States | US Oncology - Allison Cancer Center | Midland | Texas |
| United States | Cancer Care Partners, LLC | Mishawaka | Indiana |
| United States | Montana Cancer Institute Foundation | Missoula | Montana |
| United States | Charles Farber, MD | Morristown | New Jersey |
| United States | Hematology Oncology of Northern New Jersey | Morristown | New Jersey |
| United States | SCRI | Nashville | Tennessee |
| United States | Cancer Care Center, Inc. | New Albany | Indiana |
| United States | Pasco Hernando Oncology Associates (Kumar) | New Port Richey | Florida |
| United States | Oncology Specialists, S.C. | Niles | Illinois |
| United States | US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Niles | Niles | Illinois |
| United States | Northern Utah Associates | Ogden | Utah |
| United States | US Oncology - Texas Oncology - Paris | Paris | Texas |
| United States | Illinois Cancer Care | Peoria | Illinois |
| United States | New Hope Cancer & Research Institute | Pomona | California |
| United States | US Oncology - Northwest Cancer Specialists, PC - Portland - Barnes | Portland | Oregon |
| United States | US Oncology - Northwest Cancer Specialists, PC - Portland - Broadway | Portland | Oregon |
| United States | US Oncology - Northwest Cancer Specialists, PC - Portland - Hoyt | Portland | Oregon |
| United States | US Oncology - Cancer Centers of North Carolina - Falls | Raleigh | North Carolina |
| United States | US Oncology - Cancer Centers of North Carolina - Macon | Raleigh | North Carolina |
| United States | Berks Hematology Oncology Associates | Reading | Pennsylvania |
| United States | VA Sierra Nevada Healthcare System | Reno | Nevada |
| United States | US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Roanoke | Roanoke | Virginia |
| United States | St. Joseph Oncology, Inc. | Saint Joseph | Missouri |
| United States | Hematology Oncology Consultants, Inc. | Saint Louis | Missouri |
| United States | Park Nicollet Institute - Louisiana Ave. | Saint Louis Park | Minnesota |
| United States | Park Nicollet Institute Metro - MN CCOP | Saint Louis Park | Minnesota |
| United States | US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Salem | Salem | Virginia |
| United States | US Oncology - Cancer Care Centers of South Texas | San Antonio | Texas |
| United States | US Oncology - San Antonio Tumor & Blood Clinic - M. Oak | San Antonio | Texas |
| United States | US Oncology - Puget Sound Cancer Center - Seattle | Seattle | Washington |
| United States | US Oncology - Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina |
| United States | US Oncology - Texas Oncology - Sherman | Sherman | Texas |
| United States | Sanford Clinic | Sioux Falls | South Dakota |
| United States | Orchard Research | Skokie | Illinois |
| United States | Steeplechase Cancer Center | Somerville | New Jersey |
| United States | US Oncology - University of Tennessee Cancer Institute - Southaven | Southaven | Mississippi |
| United States | US Oncology - Cancer Centers of the Carolinas - Spartanburg | Spartanburg | South Carolina |
| United States | Medical Oncology Associates PS | Spokane | Washington |
| United States | US Oncology - Cancer Care Northwest - Holland | Spokane | Washington |
| United States | US Oncology - Cancer Care Northwest - Mission | Spokane | Washington |
| United States | US Oncology - Cancer Care Northwest - Sherman | Spokane | Washington |
| United States | St. John's Medical Research Institute | Springfield | Missouri |
| United States | US Oncology - Willamette Valley Cancer Institute - Springfield | Springfield | Oregon |
| United States | SUNY Upstate Medical University - Adult Program | Syracuse | New York |
| United States | Scott & White Healthcare Department of Research | Temple | Texas |
| United States | US Oncology - Northwest Cancer Specialists, PC - Tualatin | Tualatin | Oregon |
| United States | ETMC dba Blood and Cancer Center - East Texas | Tyler | Texas |
| United States | ETMC dba Tyler Hematology Oncology | Tyler | Texas |
| United States | US Oncology - Texas Oncology - Tyler | Tyler | Texas |
| United States | Carle Cancer Center | Urbana | Illinois |
| United States | US Oncology - Northwest Cancer Specialists, PC - Vancouver - 134th St | Vancouver | Washington |
| United States | US Oncology - Northwest Cancer Specialists, PC - Vancouver - 136th St. | Vancouver | Washington |
| United States | US Oncology - Texas Oncology Cancer Care and Research Center | Waco | Texas |
| United States | Providence St. Mary Regional Cancer Center | Walla Walla | Washington |
| United States | Covenant Clinic | Waterloo | Iowa |
| United States | Waukesha Memorial Hospital | Waukesha | Wisconsin |
| United States | US Oncology - Texas Oncology - Weslaco | Weslaco | Texas |
| United States | Alliance Hematology Oncology, PA | Westminster | Maryland |
| United States | Cancer Center of Kansas, PA | Wichita | Kansas |
| United States | US Oncology - Texoma Cancer Center | Wichita Falls | Texas |
| United States | US Oncology - Shenandoah Oncology - Winchester | Winchester | Virginia |
| United States | US Oncology - Cancer Care & Hematology Specialists of Chicagoland - Winfield | Winfield | Illinois |
| United States | US Oncology - Fairfax - Northern Virginia Hem-Onc, PC - Woodbridge | Woodbridge | Virginia |
| United States | Fallon Clinic | Worcester | Massachusetts |
| United States | US Oncology - Onc and Hem Assoc of Southwest VA, Inc - Wytheville | Wytheville | Virginia |
| United States | US Oncology - Yakima Valley Memorial Hospital/North Star Lodge (Boyd) | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States,
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 No — View 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) — View 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 b — View 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(®) chronic lymphocytic leukaemia regis — View 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 pat — View 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 chr — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | up to 8 years | |
| Secondary | 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 | up to 8 years | |
| Secondary | 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. | up to 8 years |
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