Chronic Lymphocytic Leukemia (CLL) Clinical Trial
— informCLLOfficial title:
informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
| NCT number | NCT02582879 |
| Other study ID # | PCYC-1134M-CA |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2015 |
| Est. completion date | July 21, 2021 |
| Verified date | July 2022 |
| Source | Pharmacyclics LLC. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 1504 |
| Est. completion date | July 21, 2021 |
| Est. primary completion date | July 21, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age of at least 18 years - Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008) - Initiating anti-CLL/SLL treatment regimen (excluding clinical trials) within ±45 days of enrollment - Availability of documentation of previous CLL/SLL treatment and duration of response in the patient's medical records if patient has received prior line(s) of treatment (i.e. NOT treatment naïve) - Willing and able to provide informed consent - Willing and able to complete PRO instrument - Willing and able to provide information on patient survey questionnaire - Willing and able to provide a blood sample at time of enrollment prior to receiving treatment, as possible Exclusion Criteria: - Diagnosis of B-cell malignancies other than CLL/SLL - Estimated life expectancy <6 months - Currently receiving treatment in an interventional clinical trial at time of entry into this study * Note- Exceptions: 1) Patients may enroll in interventional clinical trials for indications other than CLL/SLL, 2) The interventional clinical trial treatment is not the treatment used for meeting Inclusion Criteria #2 (or "Index Treatment"), 3) Patients may enroll in an interventional clinical trial indicated for CLL/SLL as later line of treatment after discontinuing the Index Treatment |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hendrick Cancer Center | Abilene | Texas |
| United States | Texas Oncology - Abilene | Abilene | Texas |
| United States | Phoebe Putney Memorial Hospital | Albany | Georgia |
| United States | Texas Oncology- Allen | Allen | Texas |
| United States | Texas Oncology - Amarillo | Amarillo | Texas |
| United States | McFarland Clinic, P.C. | Ames | Iowa |
| United States | St. Vincent Anderson Regional Hospital | Anderson | Indiana |
| United States | Texas Oncology- Arlington South | Arlington | Texas |
| United States | Texas Oncoogy - Arlington North | Arlington | Texas |
| United States | Georgia Cancer Center at Augusta University | Augusta | Georgia |
| United States | Rocky Mountain Cancer Centers, LLP- Aurora | Aurora | Colorado |
| United States | South Austin Cancer Center | Austin | Texas |
| United States | Texas Oncology - Austin Midtown | Austin | Texas |
| United States | Texas Oncology - P.A.- Austin | Austin | Texas |
| United States | Texas Oncology - PA | Beaumont | Texas |
| United States | Texas Oncology, P.A - Beaumont | Beaumont | Texas |
| United States | Texas Oncology-Bedford | Bedford | Texas |
| United States | St. Vincent Frontier Cancer Center | Billings | Montana |
| United States | Central Cancer Care Center | Bolivar | Missouri |
| United States | Rocky Mountain Cancer Centers, LLP- Boulder | Boulder | Colorado |
| United States | University Cancer Institute, LLC | Boynton Beach | Florida |
| United States | Eastchester Center for Cancer Care | Bronx | New York |
| United States | Southeast Georgia Physician Associates Hematology & Oncology | Brunswick | Georgia |
| United States | Texas Oncology - Carrollton | Carrollton | Texas |
| United States | Waverly Hematology Oncology | Cary | North Carolina |
| United States | Physicians Clinic of Iowa | Cedar Rapids | Iowa |
| United States | Charleston Cancer Center | Charleston | South Carolina |
| United States | Levine Cancer Institute | Charlotte | North Carolina |
| United States | The University of Chicago | Chicago | Illinois |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Rocky Mountain Cancer Centers | Colorado Springs | Colorado |
| United States | Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center | Columbus | Ohio |
| United States | John Muir Health | Concord | California |
| United States | Cookeville Regional Medical Center | Cookeville | Tennessee |
| United States | Pontchartrain Cancer Center | Covington | Louisiana |
| United States | Western Maryland Health System | Cumberland | Maryland |
| United States | Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
| United States | Texas Oncology - Dallas Presbyterian | Dallas | Texas |
| United States | Rocky Mountain Cancer Centers, LLP | Denver | Colorado |
| United States | Rocky Mountain Cancer Centers, LLP | Denver | Colorado |
| United States | Cancer Centers of the Carolinas- Easley | Easley | South Carolina |
| United States | St. Francis Hospital | East Hills | New York |
| United States | North Shore Hematology Oncology Associates, PC | East Setauket | New York |
| United States | Hematology Oncology Associates Of Central New York | East Syracuse | New York |
| United States | El Paso Cancer Treatment Center- West | El Paso | Texas |
| United States | Texas Oncology - El Paso | El Paso | Texas |
| United States | Texas Oncology - P.A. - El Paso | El Paso | Texas |
| United States | Trinitas Hospital | Elizabeth | New Jersey |
| United States | Hematology Oncology Physicians of Englewood, PA | Englewood | New Jersey |
| United States | Willamette Valley Cancer Institute and Research Center | Eugene | Oregon |
| United States | Providence Everett Medical Center | Everett | Washington |
| United States | San Juan Oncology Associates | Farmington | New Mexico |
| United States | Texas Oncology, P.A.- Flower Mound | Flower Mound | Texas |
| United States | Broward Oncology Associates, PA | Fort Lauderdale | Florida |
| United States | Mercy Research | Fort Smith | Arkansas |
| United States | Arizona Oncology Associates, PC - HAL | Glendale | Arizona |
| United States | Glen Falls Hospital Cancer Center | Glens Falls | New York |
| United States | Texas Oncology-Grapevine | Grapevine | Texas |
| United States | HSHS St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
| United States | Cancer Centers of the Carolinas- Butternut | Greenville | South Carolina |
| United States | Greenville Hospital System Medical Center | Greenville | South Carolina |
| United States | Hematology and Oncology Associates of SC, LLC | Greenville | South Carolina |
| United States | Leo Jenkins Cancer Center/ECU School of Medicine | Greenville | North Carolina |
| United States | Greenville Health System | Greer | South Carolina |
| United States | Antietam Oncology and Hematology Group PC | Hagerstown | Maryland |
| United States | Texas Oncology PA | Harlingen | Texas |
| United States | Ingalls Memorial Hospital | Harvey | Illinois |
| United States | Mary Lanning Healthcare Morrison Cancer Center | Hastings | Nebraska |
| United States | South Carolina Cancer Specialists | Hilton Head Island | South Carolina |
| United States | Genesis Cancer Center | Hot Springs | Arkansas |
| United States | Clearview Cancer Institute | Huntsville | Alabama |
| United States | Community Health Network | Indianapolis | Indiana |
| United States | Investigative Clinical Research of Indiana, LLC | Indianapolis | Indiana |
| United States | Jackson Madison County General Hospital | Jackson | Tennessee |
| United States | Jackson Oncology Associates | Jackson | Mississippi |
| United States | Baptist MD Anderson Cancer Center | Jacksonville | Florida |
| United States | Cancer Specialists, LLC | Jacksonville | Florida |
| United States | Jefferson City Medical Group | Jefferson City | Missouri |
| United States | Clopton Clinic of Jonesboro, Inc. | Jonesboro | Arkansas |
| United States | West Michigan Cancer Center | Kalamazoo | Michigan |
| United States | Horizon Oncology Research, Inc | Lafayette | Indiana |
| United States | Lakeland Regional Health Systems Inc | Lakeland | Florida |
| United States | Watson Clinic Cancer and Research Center | Lakeland | Florida |
| United States | Rocky Mountain Cancer Centers, LLP- Lakewood | Lakewood | Colorado |
| United States | Lancaster Cancer Center | Lancaster | Pennsylvania |
| United States | Maine Research Associates | Lewiston | Maine |
| United States | Nebraska Hematology-Oncology, P.C | Lincoln | Nebraska |
| United States | Southeast Nebraska Cancer Center | Lincoln | Nebraska |
| United States | CARTI - Central Arkansas Radiation Therapy Institute | Little Rock | Arkansas |
| United States | Rocky Mountain Cancer Centers, LLP- Littleton | Littleton | Colorado |
| United States | Rocky Mountain Cancer Centers, LLP- Sky Ridge | Lone Tree | Colorado |
| United States | Rocky Mountain Cancer Centers, LLP- Longmont | Longmont | Colorado |
| United States | Texas Oncology - P.A.- Longview | Longview | Texas |
| United States | North Shore Long Island Jewish Hospital | Manhasset | New York |
| United States | Texas Oncology - P.A.-McAllen | McAllen | Texas |
| United States | Texas Oncology- McKinney | McKinney | Texas |
| United States | Hematology Oncology Associates | Medford | Oregon |
| United States | Hematology Oncology Associates, PC | Medford | Oregon |
| United States | Texas Oncology -P.A.- Mesquite | Mesquite | Texas |
| United States | Wright State University | Middletown | Ohio |
| United States | Texas Oncology - P.A.- Midland | Midland | Texas |
| United States | University Cancer Institute, LLC | Monroeville | Pennsylvania |
| United States | Raab Clinic | Morehead City | North Carolina |
| United States | Northern Westchester Hospital | Mount Kisco | New York |
| United States | Montgomery Cancer Center | Mount Sterling | Kentucky |
| United States | Northwest Alabama Cancer Center, PC | Muscle Shoals | Alabama |
| United States | Meharry Medical College | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Meridian Health Systems | Neptune | New Jersey |
| United States | Saint Peter's University Hospital | New Brunswick | New Jersey |
| United States | Tulane University | New Orleans | Louisiana |
| United States | MHO Research Foundation, Inc. | New York | New York |
| United States | Cancer Specialists of Tidewater | Newport News | Virginia |
| United States | Mid-Illinois Hematology & Oncology Associates,Ltd. | Normal | Illinois |
| United States | St John Providence Hospital | Novi | Michigan |
| United States | Hematology Oncology Associates of Rockland | Nyack | New York |
| United States | North County Oncology Medical Clinic | Oceanside | California |
| United States | Texas Oncology - P.A.- Odessa | Odessa | Texas |
| United States | Mercy Research - Mercy Clinic Oncology and Hematology | Oklahoma City | Oklahoma |
| United States | Cancer Alliance of Nebraska | Omaha | Nebraska |
| United States | West Ky Hematology & Oncology Group, PSC | Paducah | Kentucky |
| United States | The Valley Hospital | Paramus | New Jersey |
| United States | Texas Oncology - P.A.- Paris | Paris | Texas |
| United States | Rocky Mountain Cancer Centers, LLP- Parker | Parker | Colorado |
| United States | Sacred Heart Cancer Center | Pensacola | Florida |
| United States | Illinois Cancer Care, P.C. | Peoria | Illinois |
| United States | Einstein Medical Center | Philadelphia | Pennsylvania |
| United States | Arizona Oncology Associates, PC - HAL | Phoenix | Arizona |
| United States | Arizona Oncology Associates, PC - HAL | Phoenix | Arizona |
| United States | Berkshire Hematology Oncology, PC | Pittsfield | Massachusetts |
| United States | Texas Oncology - P.A.- Plano | Plano | Texas |
| United States | Texas Oncology- Plano West | Plano | Texas |
| United States | Beth Israel Deaconess Hospital- Plymouth | Plymouth | Massachusetts |
| United States | Compass Oncology- Barnes | Portland | Oregon |
| United States | Compass Oncology- Broadway | Portland | Oregon |
| United States | Compass Oncology- Hoyt | Portland | Oregon |
| United States | Rocky Mountain Cancer Centers, LLP- Pueblo | Pueblo | Colorado |
| United States | Carolina Blood and Cancer Care Associates | Rock Hill | South Carolina |
| United States | OSF Saint Anthony Medical Center | Rockford | Illinois |
| United States | Penobscot Bay Medical Center | Rockport | Maine |
| United States | Texas Oncology - Rockwall | Rockwall | Texas |
| United States | Coborn Cancer Center | Saint Cloud | Minnesota |
| United States | Gregory Smith, MD (Private Practice) | Saint Helena | California |
| United States | Heartland Regional Medical Center d/b/a Cancer Care St. Joseph Mosaic Life Care | Saint Joseph | Missouri |
| United States | Texas Oncology- San Antonio Downtown | San Antonio | Texas |
| United States | Texas Oncology- San Antonio Northeast | San Antonio | Texas |
| United States | Texas Oncology- San Antonio Stone Oak | San Antonio | Texas |
| United States | Sansum Clinic | Santa Barbara | California |
| United States | St Joseph Heritage Healthcare | Santa Rosa | California |
| United States | Maine Center for Cancer Medicine | Scarborough | Maine |
| United States | Hematology & Oncology Associates of Northeastern PA | Scranton | Pennsylvania |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina |
| United States | Texas Oncology - P.A.-Sherman | Sherman | Texas |
| United States | Christus Cancer Treatment Center | Shreveport | Louisiana |
| United States | Willis-Knighton Cancer Center | Shreveport | Louisiana |
| United States | Orchard Healthcare Research Inc. | Skokie | Illinois |
| United States | Sansum Clinic | Solvang | California |
| United States | Memorial Medical Group Clinical Research Institute | South Bend | Indiana |
| United States | Cancer Centers of the Carolinas- Spartanburg | Spartanburg | South Carolina |
| United States | Spartanburg Regional Healthcare System | Spartanburg | South Carolina |
| United States | Willamette Valley Cancer Institute and Research Center | Springfield | Oregon |
| United States | Texas Oncology - P.A.-Sugar Land | Sugar Land | Texas |
| United States | SUNY Upstate Medical Center | Syracuse | New York |
| United States | Multicare Institute for Research and Innovation | Tacoma | Washington |
| United States | Arizona Oncology Associates, PC - HAL-Scottsdale | Tempe | Arizona |
| United States | Rocky Mountain Cancer Centers, LLP- Thornton | Thornton | Colorado |
| United States | Healthcare Research Network III, LLC | Tinley Park | Illinois |
| United States | Toledo Community Hospital Oncology Program - CCOP Toledo | Toledo | Ohio |
| United States | Cotton-O'Neil Clinical Research Center, Hematology and Oncology | Topeka | Kansas |
| United States | Compass Oncology- Tualatin | Tualatin | Oregon |
| United States | Texas Oncology-P.A-Tyler | Tyler | Texas |
| United States | Tyler Hematology Oncology | Tyler | Texas |
| United States | Solano Hematology Oncology | Vallejo | California |
| United States | Compass oncology | Vancouver | Washington |
| United States | Good Samaritan Hospital | Vincennes | Indiana |
| United States | Texas Oncology, P.A. - Horizon Circle | Waco | Texas |
| United States | Texas Oncology, P.A. - Waco | Waco | Texas |
| United States | Providence St. Mary Regional Cancer Center | Walla Walla | Washington |
| United States | Covenant Clinic | Waterloo | Iowa |
| United States | Prairie Lakes Hospital | Watertown | South Dakota |
| United States | ProHealth Care | Waukesha | Wisconsin |
| United States | Texas Oncology-P.A.- Webster | Webster | Texas |
| United States | Texas Oncology-Weslaco | Weslaco | Texas |
| United States | White Plains Hospital | White Plains | New York |
| United States | Susquehanna Cancer Center | Williamsport | Pennsylvania |
| United States | Southern Oncology Hematology Associates | Williamstown | New Jersey |
| United States | CCS Oncology | Williamsville | New York |
| United States | Shenandoah Oncology, P.C. | Winchester | Virginia |
| United States | Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington |
| United States | Cancer Care Associates of York | York | Pennsylvania |
| United States | St. Elizabeth Hospital | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Pharmacyclics LLC. | Janssen, LP |
United States,
Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Döhner 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. Erratum in: Blood. 2008 Dec 15;112(13):5259. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Summarize baseline characteristics of study population, among CLL patients in a real-world setting | - Summarize baseline characteristics of study participants | up to 7 years | |
| Primary | Summarize treatment patterns among CLL patients in a real-world setting | Summarize number of participants on various initial and subsequent treatments
Summarize proportion of patients switching therapies at each follow up time point |
up to 7 years | |
| Primary | 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 | |
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
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