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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
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The study is designed as a multicenter, prospective, observational registry of CLL/SLL patients who are initiating approved oral kinase inhibitors, BCL-2 inhibitors or other approved anti-CLL therapies/regimens. The study will characterize treatment patterns and their association with patient characteristics, healthcare resource utilization, and clinical outcomes, as well as patient-reported outcome (PRO) measures.
This multicenter, prospective, observational registry of CLL patients is designed to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors and other approved anti-CLL therapies/ regimens. The registry will provide information on regimens used to treat first-line and later lines of CLL as well as the sequencing of treatment regimens. The registry will also evaluate the association of these treatment patterns with patient characteristics, healthcare resource utilization, and functional outcomes including patient-reported HRQoL. These data will provide information to physicians that may help guide clinical practice and appropriate use of therapies, and will also provide information on HRQoL and healthcare resource utilization that will be of interest to healthcare decision makers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with CLL/SLL | Patients with CLL/SLL in a real-world setting initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL therapies/regimens. |
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| Measure | Description | Time Frame |
|---|---|---|
| Summarize baseline characteristics of study population, among CLL patients in a real-world setting | - Summarize baseline characteristics of study participants | up to 7 years |
| Summarize treatment patterns among CLL patients in a real-world setting |
| up to 7 years |
| Summarize clinical outcomes among CLL patients in a real-world setting | - Measures of effectiveness used will include survival status, ECOG Health status, response assessments as evaluated by the investigator such as: complete response, partial response, stable disease, progressive disease | up to 7 years |
| Summarize health care resource utilization among CLL patients in a real-world setting | - Summarize health care resource utilization among study participants | up to 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Summarize non serious adverse events (AEs) that led to discontinuation/modification/interruption of therapy and all serious adverse events in CLL patients | - Summarize frequencies and percentages of AEs, that led to discontinuation/modification/interruption of therapy or death in CLL patients | up to 7 years |
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Inclusion Criteria:
Exclusion Criteria:
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The registry will aim to enroll approximately 1500 patients with CLL/SLL from a total of 200 sites in the US over a 45 month enrollment period. In order to best capture real-world treatment patterns, site recruitment will aim to include approximately 85% of sites from the community hematology-oncology setting.
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| Name | Affiliation | Role |
|---|---|---|
| Alex Young | Pharmacyclics LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | United States | ||
| Northwest Alabama Cancer Center, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18216293 | Background | Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Dohner H, Hillmen P, Keating MJ, Montserrat E, Rai KR, Kipps TJ; International Workshop on Chronic Lymphocytic Leukemia. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008 Jun 15;111(12):5446-56. doi: 10.1182/blood-2007-06-093906. Epub 2008 Jan 23. |
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blood samples
| Summarize patient-reported HRQoL scores |
- Summarize HRQoL scores as measured by FACT-G and additional questions from other PRO instruments at baseline and each follow-up |
| up to 7 years |
| Muscle Shoals |
| Alabama |
| 35661 |
| United States |
| Arizona Oncology Associates, PC - HAL | Glendale | Arizona | 85308 | United States |
| Arizona Oncology Associates, PC - HAL | Phoenix | Arizona | 85016 | United States |
| Arizona Oncology Associates, PC - HAL | Phoenix | Arizona | 85027 | United States |
| Arizona Oncology Associates, PC - HAL-Scottsdale | Tempe | Arizona | 85284 | United States |
| Mercy Research | Fort Smith | Arkansas | 72903 | United States |
| Genesis Cancer Center | Hot Springs | Arkansas | 71913 | United States |
| Clopton Clinic of Jonesboro, Inc. | Jonesboro | Arkansas | 72401 | United States |
| CARTI - Central Arkansas Radiation Therapy Institute | Little Rock | Arkansas | 72205 | United States |
| John Muir Health | Concord | California | 94520 | United States |
| North County Oncology Medical Clinic | Oceanside | California | 92056 | United States |
| Sansum Clinic | Santa Barbara | California | 93105 | United States |
| St Joseph Heritage Healthcare | Santa Rosa | California | 95403 | United States |
| Sansum Clinic | Solvang | California | 93463 | United States |
| Gregory Smith, MD (Private Practice) | St. Helena | California | 94574 | United States |
| Solano Hematology Oncology | Vallejo | California | 94589 | United States |
| Rocky Mountain Cancer Centers, LLP- Aurora | Aurora | Colorado | 80012 | United States |
| Rocky Mountain Cancer Centers, LLP- Boulder | Boulder | Colorado | 80303 | United States |
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80907 | United States |
| Rocky Mountain Cancer Centers, LLP | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers, LLP | Denver | Colorado | 80220 | United States |
| Rocky Mountain Cancer Centers, LLP- Lakewood | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer Centers, LLP- Littleton | Littleton | Colorado | 80120-4413 | United States |
| Rocky Mountain Cancer Centers, LLP- Sky Ridge | Lone Tree | Colorado | 80124 | United States |
| Rocky Mountain Cancer Centers, LLP- Longmont | Longmont | Colorado | 80501 | United States |
| Rocky Mountain Cancer Centers, LLP- Parker | Parker | Colorado | 80138 | United States |
| Rocky Mountain Cancer Centers, LLP- Pueblo | Pueblo | Colorado | 81008 | United States |
| Rocky Mountain Cancer Centers, LLP- Thornton | Thornton | Colorado | 80260 | United States |
| University Cancer Institute, LLC | Boynton Beach | Florida | 33426 | United States |
| Broward Oncology Associates, PA | Fort Lauderdale | Florida | 33308 | United States |
| Cancer Specialists, LLC | Jacksonville | Florida | 32082 | United States |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | United States |
| Lakeland Regional Health Systems Inc | Lakeland | Florida | 33805 | United States |
| Watson Clinic Cancer and Research Center | Lakeland | Florida | 33805 | United States |
| Sacred Heart Cancer Center | Pensacola | Florida | 32504 | United States |
| Phoebe Putney Memorial Hospital | Albany | Georgia | 31701 | United States |
| Georgia Cancer Center at Augusta University | Augusta | Georgia | 30912 | United States |
| Southeast Georgia Physician Associates Hematology & Oncology | Brunswick | Georgia | 31520 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Mid-Illinois Hematology & Oncology Associates,Ltd. | Normal | Illinois | 61761 | United States |
| Illinois Cancer Care, P.C. | Peoria | Illinois | 61615-7828 | United States |
| OSF Saint Anthony Medical Center | Rockford | Illinois | 61108 | United States |
| Orchard Healthcare Research Inc. | Skokie | Illinois | 60077 | United States |
| Healthcare Research Network III, LLC | Tinley Park | Illinois | 60487 | United States |
| St. Vincent Anderson Regional Hospital | Anderson | Indiana | 46016 | United States |
| Community Health Network | Indianapolis | Indiana | 46219 | United States |
| Investigative Clinical Research of Indiana, LLC | Indianapolis | Indiana | 46260 | United States |
| Horizon Oncology Research, Inc | Lafayette | Indiana | 47905 | United States |
| Memorial Medical Group Clinical Research Institute | South Bend | Indiana | 46601 | United States |
| Good Samaritan Hospital | Vincennes | Indiana | 47591 | United States |
| McFarland Clinic, P.C. | Ames | Iowa | 50010-3014 | United States |
| Physicians Clinic of Iowa | Cedar Rapids | Iowa | 52402 | United States |
| Covenant Clinic | Waterloo | Iowa | 50702 | United States |
| Cotton-O'Neil Clinical Research Center, Hematology and Oncology | Topeka | Kansas | 66606 | United States |
| Montgomery Cancer Center | Mount Sterling | Kentucky | 40353 | United States |
| West Ky Hematology & Oncology Group, PSC | Paducah | Kentucky | 42003 | United States |
| Pontchartrain Cancer Center | Covington | Louisiana | 70433 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Willis-Knighton Cancer Center | Shreveport | Louisiana | 71103 | United States |
| Christus Cancer Treatment Center | Shreveport | Louisiana | 71105 | United States |
| Maine Research Associates | Lewiston | Maine | 04240 | United States |
| Penobscot Bay Medical Center | Rockport | Maine | 04856 | United States |
| Maine Center for Cancer Medicine | Scarborough | Maine | 04074 | United States |
| Western Maryland Health System | Cumberland | Maryland | 21502 | United States |
| Antietam Oncology and Hematology Group PC | Hagerstown | Maryland | 21740 | United States |
| Berkshire Hematology Oncology, PC | Pittsfield | Massachusetts | 01201 | United States |
| Beth Israel Deaconess Hospital- Plymouth | Plymouth | Massachusetts | 02360 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| St John Providence Hospital | Novi | Michigan | 48374-1233 | United States |
| Coborn Cancer Center | Saint Cloud | Minnesota | 56303 | United States |
| Jackson Oncology Associates | Jackson | Mississippi | 39202 | United States |
| Central Cancer Care Center | Bolivar | Missouri | 65613 | United States |
| Jefferson City Medical Group | Jefferson City | Missouri | 65109 | United States |
| Heartland Regional Medical Center d/b/a Cancer Care St. Joseph Mosaic Life Care | Saint Joseph | Missouri | 64506 | United States |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59102 | United States |
| Mary Lanning Healthcare Morrison Cancer Center | Hastings | Nebraska | 68901 | United States |
| Nebraska Hematology-Oncology, P.C | Lincoln | Nebraska | 68506 | United States |
| Southeast Nebraska Cancer Center | Lincoln | Nebraska | 68510 | United States |
| Cancer Alliance of Nebraska | Omaha | Nebraska | 68106 | United States |
| Trinitas Hospital | Elizabeth | New Jersey | 07207 | United States |
| Hematology Oncology Physicians of Englewood, PA | Englewood | New Jersey | 07631 | United States |
| Meridian Health Systems | Neptune City | New Jersey | 07753 | United States |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
| Southern Oncology Hematology Associates | Williamstown | New Jersey | 08360 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| St. Francis Hospital | East Hills | New York | 11548 | United States |
| North Shore Hematology Oncology Associates, PC | East Setauket | New York | 11733 | United States |
| Hematology Oncology Associates Of Central New York | East Syracuse | New York | 13057 | United States |
| Glen Falls Hospital Cancer Center | Glens Falls | New York | 12801 | United States |
| North Shore Long Island Jewish Hospital | Manhasset | New York | 11030 | United States |
| Northern Westchester Hospital | Mount Kisco | New York | 10549 | United States |
| MHO Research Foundation, Inc. | New York | New York | 10016 | United States |
| Hematology Oncology Associates of Rockland | Nyack | New York | 10960 | United States |
| SUNY Upstate Medical Center | Syracuse | New York | 13210 | United States |
| Eastchester Center for Cancer Care | The Bronx | New York | 10469 | United States |
| White Plains Hospital | White Plains | New York | 10601 | United States |
| CCS Oncology | Williamsville | New York | 14221 | United States |
| Waverly Hematology Oncology | Cary | North Carolina | 27518 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Leo Jenkins Cancer Center/ECU School of Medicine | Greenville | North Carolina | 27834 | United States |
| Raab Clinic | Morehead City | North Carolina | 28557 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Wright State University | Middletown | Ohio | 45005 | United States |
| Toledo Community Hospital Oncology Program - CCOP Toledo | Toledo | Ohio | 43623 | United States |
| St. Elizabeth Hospital | Youngstown | Ohio | 44501 | United States |
| Mercy Research - Mercy Clinic Oncology and Hematology | Oklahoma City | Oklahoma | 73120 | United States |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | United States |
| Hematology Oncology Associates, PC | Medford | Oregon | 97504 | United States |
| Hematology Oncology Associates | Medford | Oregon | 97504 | United States |
| Compass Oncology- Hoyt | Portland | Oregon | 97213-2982 | United States |
| Compass Oncology- Barnes | Portland | Oregon | 97225 | United States |
| Compass Oncology- Broadway | Portland | Oregon | 97227 | United States |
| Willamette Valley Cancer Institute and Research Center | Springfield | Oregon | 97477 | United States |
| Compass Oncology- Tualatin | Tualatin | Oregon | 97062 | United States |
| Lancaster Cancer Center | Lancaster | Pennsylvania | 17605 | United States |
| University Cancer Institute, LLC | Monroeville | Pennsylvania | 15232 | United States |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Hematology & Oncology Associates of Northeastern PA | Scranton | Pennsylvania | 18510 | United States |
| Susquehanna Cancer Center | Williamsport | Pennsylvania | 17701 | United States |
| Cancer Care Associates of York | York | Pennsylvania | 17403 | United States |
| Charleston Cancer Center | Charleston | South Carolina | 29406 | United States |
| Cancer Centers of the Carolinas- Easley | Easley | South Carolina | 29640 | United States |
| Cancer Centers of the Carolinas- Butternut | Greenville | South Carolina | 29605 | United States |
| Hematology and Oncology Associates of SC, LLC | Greenville | South Carolina | 29605 | United States |
| Greenville Hospital System Medical Center | Greenville | South Carolina | 29615 | United States |
| Greenville Health System | Greer | South Carolina | 29650 | United States |
| South Carolina Cancer Specialists | Hilton Head Island | South Carolina | 29926 | United States |
| Carolina Blood and Cancer Care Associates | Rock Hill | South Carolina | 29732 | United States |
| Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina | 29672 | United States |
| Spartanburg Regional Healthcare System | Spartanburg | South Carolina | 29303 | United States |
| Cancer Centers of the Carolinas- Spartanburg | Spartanburg | South Carolina | 29307 | United States |
| Prairie Lakes Hospital | Watertown | South Dakota | 57201 | United States |
| Cookeville Regional Medical Center | Cookeville | Tennessee | 38501 | United States |
| Jackson Madison County General Hospital | Jackson | Tennessee | 38301 | United States |
| Meharry Medical College | Nashville | Tennessee | 37208 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Hendrick Cancer Center | Abilene | Texas | 79601 | United States |
| Texas Oncology - Abilene | Abilene | Texas | 79606-5208 | United States |
| Texas Oncology- Allen | Allen | Texas | 75013 | United States |
| Texas Oncology - Amarillo | Amarillo | Texas | 79106 | United States |
| Texas Oncoogy - Arlington North | Arlington | Texas | 76012 | United States |
| Texas Oncology- Arlington South | Arlington | Texas | 76014 | United States |
| Texas Oncology - Austin Midtown | Austin | Texas | 78705 | United States |
| Texas Oncology - P.A.- Austin | Austin | Texas | 78731 | United States |
| South Austin Cancer Center | Austin | Texas | 78745 | United States |
| Texas Oncology - PA | Beaumont | Texas | 77701 | United States |
| Texas Oncology, P.A - Beaumont | Beaumont | Texas | 77702 | United States |
| Texas Oncology-Bedford | Bedford | Texas | 76022 | United States |
| Texas Oncology - Carrollton | Carrollton | Texas | 75010 | United States |
| Texas Oncology - Dallas Presbyterian | Dallas | Texas | 75231 | United States |
| Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| El Paso Cancer Treatment Center- West | El Paso | Texas | 79902 | United States |
| Texas Oncology - P.A. - El Paso | El Paso | Texas | 79915 | United States |
| Texas Oncology - El Paso | El Paso | Texas | 79939 | United States |
| Texas Oncology, P.A.- Flower Mound | Flower Mound | Texas | 75028 | United States |
| Texas Oncology-Grapevine | Grapevine | Texas | 76051 | United States |
| Texas Oncology PA | Harlingen | Texas | 78550 | United States |
| Texas Oncology - P.A.- Longview | Longview | Texas | 75601 | United States |
| Texas Oncology - P.A.-McAllen | McAllen | Texas | 78503 | United States |
| Texas Oncology- McKinney | McKinney | Texas | 75071 | United States |
| Texas Oncology -P.A.- Mesquite | Mesquite | Texas | 75150 | United States |
| Texas Oncology - P.A.- Midland | Midland | Texas | 79701 | United States |
| Texas Oncology - P.A.- Odessa | Odessa | Texas | 79761 | United States |
| Texas Oncology - P.A.- Paris | Paris | Texas | 75460-5004 | United States |
| Texas Oncology - P.A.- Plano | Plano | Texas | 75075-7787 | United States |
| Texas Oncology- Plano West | Plano | Texas | 75093 | United States |
| Texas Oncology - Rockwall | Rockwall | Texas | 75032 | United States |
| Texas Oncology- San Antonio Downtown | San Antonio | Texas | 78212 | United States |
| Texas Oncology- San Antonio Northeast | San Antonio | Texas | 78217 | United States |
| Texas Oncology- San Antonio Stone Oak | San Antonio | Texas | 78258 | United States |
| Texas Oncology - P.A.-Sherman | Sherman | Texas | 75090 | United States |
| Texas Oncology - P.A.-Sugar Land | Sugar Land | Texas | 77479 | United States |
| Tyler Hematology Oncology | Tyler | Texas | 75701 | United States |
| Texas Oncology-P.A-Tyler | Tyler | Texas | 75702 | United States |
| Texas Oncology, P.A. - Horizon Circle | Waco | Texas | 76712 | United States |
| Texas Oncology, P.A. - Waco | Waco | Texas | 76712 | United States |
| Texas Oncology-P.A.- Webster | Webster | Texas | 77598-4420 | United States |
| Texas Oncology-Weslaco | Weslaco | Texas | 78596 | United States |
| Cancer Specialists of Tidewater | Newport News | Virginia | 23601 | United States |
| Shenandoah Oncology, P.C. | Winchester | Virginia | 22601 | United States |
| Providence Everett Medical Center | Everett | Washington | 98201 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Multicare Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| Compass oncology | Vancouver | Washington | 98684 | United States |
| Providence St. Mary Regional Cancer Center | Walla Walla | Washington | 99362 | United States |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington | 98902 | United States |
| HSHS St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54301 | United States |
| ProHealth Care | Waukesha | Wisconsin | 53188 | United States |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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