informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Registration Number
- NCT02582879
- Lead Sponsor
- Pharmacyclics LLC.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1504
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Summarize baseline characteristics of study population, among CLL patients in a real-world setting up to 7 years - Summarize baseline characteristics of study participants
Summarize clinical outcomes among CLL patients in a real-world setting up to 7 years - 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
Summarize treatment patterns among CLL patients in a real-world setting up to 7 years * Summarize number of participants on various initial and subsequent treatments
* Summarize proportion of patients switching therapies at each follow up time pointSummarize health care resource utilization among CLL patients in a real-world setting up to 7 years - Summarize health care resource utilization among study participants
- Secondary Outcome Measures
Name Time Method Summarize non serious adverse events (AEs) that led to discontinuation/modification/interruption of therapy and all serious adverse events in CLL patients up to 7 years - Summarize frequencies and percentages of AEs, that led to discontinuation/modification/interruption of therapy or death in CLL patients
Summarize patient-reported HRQoL scores up to 7 years - Summarize HRQoL scores as measured by FACT-G and additional questions from other PRO instruments at baseline and each follow-up
Trial Locations
- Locations (186)
Hematology Oncology Associates Of Central New York
🇺🇸East Syracuse, New York, United States
Texas Oncology- Arlington South
🇺🇸Arlington, Texas, United States
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Northwest Alabama Cancer Center, PC
🇺🇸Muscle Shoals, Alabama, United States
Arizona Oncology Associates, PC - HAL-Scottsdale
🇺🇸Tempe, Arizona, United States
Mercy Research
🇺🇸Fort Smith, Arkansas, United States
CARTI - Central Arkansas Radiation Therapy Institute
🇺🇸Little Rock, Arkansas, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Clopton Clinic of Jonesboro, Inc.
🇺🇸Jonesboro, Arkansas, United States
North County Oncology Medical Clinic
🇺🇸Oceanside, California, United States
John Muir Health
🇺🇸Concord, California, United States
Gregory Smith, MD (Private Practice)
🇺🇸Saint Helena, California, United States
Sansum Clinic
🇺🇸Solvang, California, United States
St Joseph Heritage Healthcare
🇺🇸Santa Rosa, California, United States
Rocky Mountain Cancer Centers, LLP- Littleton
🇺🇸Littleton, Colorado, United States
Solano Hematology Oncology
🇺🇸Vallejo, California, United States
Rocky Mountain Cancer Centers, LLP- Boulder
🇺🇸Boulder, Colorado, United States
Rocky Mountain Cancer Centers, LLP- Lakewood
🇺🇸Lakewood, Colorado, United States
Rocky Mountain Cancer Centers
🇺🇸Colorado Springs, Colorado, United States
Broward Oncology Associates, PA
🇺🇸Fort Lauderdale, Florida, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Rocky Mountain Cancer Centers, LLP- Sky Ridge
🇺🇸Lone Tree, Colorado, United States
University Cancer Institute, LLC
🇺🇸Monroeville, Pennsylvania, United States
Southeast Georgia Physician Associates Hematology & Oncology
🇺🇸Brunswick, Georgia, United States
Rocky Mountain Cancer Centers, LLP- Longmont
🇺🇸Longmont, Colorado, United States
Rocky Mountain Cancer Centers, LLP- Pueblo
🇺🇸Pueblo, Colorado, United States
Rocky Mountain Cancer Centers, LLP- Parker
🇺🇸Parker, Colorado, United States
Georgia Cancer Center at Augusta University
🇺🇸Augusta, Georgia, United States
Rocky Mountain Cancer Centers, LLP- Thornton
🇺🇸Thornton, Colorado, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Lakeland Regional Health Systems Inc
🇺🇸Lakeland, Florida, United States
Watson Clinic Cancer and Research Center
🇺🇸Lakeland, Florida, United States
Phoebe Putney Memorial Hospital
🇺🇸Albany, Georgia, United States
OSF Saint Anthony Medical Center
🇺🇸Rockford, Illinois, United States
Covenant Clinic
🇺🇸Waterloo, Iowa, United States
Orchard Healthcare Research Inc.
🇺🇸Skokie, Illinois, United States
Sacred Heart Cancer Center
🇺🇸Pensacola, Florida, United States
Cotton-O'Neil Clinical Research Center, Hematology and Oncology
🇺🇸Topeka, Kansas, United States
St. Vincent Anderson Regional Hospital
🇺🇸Anderson, Indiana, United States
Montgomery Cancer Center
🇺🇸Mount Sterling, Kentucky, United States
Mid-Illinois Hematology & Oncology Associates,Ltd.
🇺🇸Normal, Illinois, United States
Illinois Cancer Care, P.C.
🇺🇸Peoria, Illinois, United States
Healthcare Research Network III, LLC
🇺🇸Tinley Park, Illinois, United States
Good Samaritan Hospital
🇺🇸Vincennes, Indiana, United States
Horizon Oncology Research, Inc
🇺🇸Lafayette, Indiana, United States
Memorial Medical Group Clinical Research Institute
🇺🇸South Bend, Indiana, United States
Physicians Clinic of Iowa
🇺🇸Cedar Rapids, Iowa, United States
McFarland Clinic, P.C.
🇺🇸Ames, Iowa, United States
West Ky Hematology & Oncology Group, PSC
🇺🇸Paducah, Kentucky, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
Pontchartrain Cancer Center
🇺🇸Covington, Louisiana, United States
Penobscot Bay Medical Center
🇺🇸Rockport, Maine, United States
Nebraska Hematology-Oncology, P.C
🇺🇸Lincoln, Nebraska, United States
Beth Israel Deaconess Hospital- Plymouth
🇺🇸Plymouth, Massachusetts, United States
Hematology Oncology Physicians of Englewood, PA
🇺🇸Englewood, New Jersey, United States
Maine Center for Cancer Medicine
🇺🇸Scarborough, Maine, United States
St John Providence Hospital
🇺🇸Novi, Michigan, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Maine Research Associates
🇺🇸Lewiston, Maine, United States
Willis-Knighton Cancer Center
🇺🇸Shreveport, Louisiana, United States
Jefferson City Medical Group
🇺🇸Jefferson City, Missouri, United States
Berkshire Hematology Oncology, PC
🇺🇸Pittsfield, Massachusetts, United States
Christus Cancer Treatment Center
🇺🇸Shreveport, Louisiana, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Antietam Oncology and Hematology Group PC
🇺🇸Hagerstown, Maryland, United States
Heartland Regional Medical Center d/b/a Cancer Care St. Joseph Mosaic Life Care
🇺🇸Saint Joseph, Missouri, United States
Western Maryland Health System
🇺🇸Cumberland, Maryland, United States
Jackson Oncology Associates
🇺🇸Jackson, Mississippi, United States
Central Cancer Care Center
🇺🇸Bolivar, Missouri, United States
Mary Lanning Healthcare Morrison Cancer Center
🇺🇸Hastings, Nebraska, United States
Southern Oncology Hematology Associates
🇺🇸Williamstown, New Jersey, United States
Meridian Health Systems
🇺🇸Neptune, New Jersey, United States
St. Vincent Frontier Cancer Center
🇺🇸Billings, Montana, United States
Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
Trinitas Hospital
🇺🇸Elizabeth, New Jersey, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
The Valley Hospital
🇺🇸Paramus, New Jersey, United States
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
Eastchester Center for Cancer Care
🇺🇸Bronx, New York, United States
St. Francis Hospital
🇺🇸East Hills, New York, United States
North Shore Hematology Oncology Associates, PC
🇺🇸East Setauket, New York, United States
Glen Falls Hospital Cancer Center
🇺🇸Glens Falls, New York, United States
North Shore Long Island Jewish Hospital
🇺🇸Manhasset, New York, United States
MHO Research Foundation, Inc.
🇺🇸New York, New York, United States
Northern Westchester Hospital
🇺🇸Mount Kisco, New York, United States
White Plains Hospital
🇺🇸White Plains, New York, United States
SUNY Upstate Medical Center
🇺🇸Syracuse, New York, United States
Waverly Hematology Oncology
🇺🇸Cary, North Carolina, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Leo Jenkins Cancer Center/ECU School of Medicine
🇺🇸Greenville, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Raab Clinic
🇺🇸Morehead City, North Carolina, United States
Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
🇺🇸Columbus, Ohio, United States
Toledo Community Hospital Oncology Program - CCOP Toledo
🇺🇸Toledo, Ohio, United States
Wright State University
🇺🇸Middletown, Ohio, United States
St. Elizabeth Hospital
🇺🇸Youngstown, Ohio, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Springfield, Oregon, United States
Hematology Oncology Associates, PC
🇺🇸Medford, Oregon, United States
Hematology Oncology Associates
🇺🇸Medford, Oregon, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Compass Oncology- Tualatin
🇺🇸Tualatin, Oregon, United States
Lancaster Cancer Center
🇺🇸Lancaster, Pennsylvania, United States
Hematology & Oncology Associates of Northeastern PA
🇺🇸Scranton, Pennsylvania, United States
Susquehanna Cancer Center
🇺🇸Williamsport, Pennsylvania, United States
Cancer Care Associates of York
🇺🇸York, Pennsylvania, United States
Cancer Centers of the Carolinas- Easley
🇺🇸Easley, South Carolina, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Cancer Centers of the Carolinas- Butternut
🇺🇸Greenville, South Carolina, United States
Hematology and Oncology Associates of SC, LLC
🇺🇸Greenville, South Carolina, United States
Greenville Hospital System Medical Center
🇺🇸Greenville, South Carolina, United States
Greenville Health System
🇺🇸Greer, South Carolina, United States
South Carolina Cancer Specialists
🇺🇸Hilton Head Island, South Carolina, United States
Carolina Blood and Cancer Care Associates
🇺🇸Rock Hill, South Carolina, United States
Cancer Centers of the Carolinas - Seneca
🇺🇸Seneca, South Carolina, United States
Spartanburg Regional Healthcare System
🇺🇸Spartanburg, South Carolina, United States
Cookeville Regional Medical Center
🇺🇸Cookeville, Tennessee, United States
Prairie Lakes Hospital
🇺🇸Watertown, South Dakota, United States
Cancer Centers of the Carolinas- Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Jackson Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Hendrick Cancer Center
🇺🇸Abilene, Texas, United States
Texas Oncoogy - Arlington North
🇺🇸Arlington, Texas, United States
Texas Oncology - Austin Midtown
🇺🇸Austin, Texas, United States
Texas Oncology - P.A.- Austin
🇺🇸Austin, Texas, United States
South Austin Cancer Center
🇺🇸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
Texas Oncology - Dallas Presbyterian
🇺🇸Dallas, Texas, United States
Texas Oncology - Carrollton
🇺🇸Carrollton, Texas, United States
Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
El Paso Cancer Treatment Center- West
🇺🇸El Paso, Texas, United States
Texas Oncology - P.A. - El Paso
🇺🇸El Paso, Texas, United States
Texas Oncology - El Paso
🇺🇸El Paso, Texas, United States
Texas Oncology, P.A.- Flower Mound
🇺🇸Flower Mound, Texas, United States
Texas Oncology-Grapevine
🇺🇸Grapevine, Texas, United States
Texas Oncology PA
🇺🇸Harlingen, Texas, United States
Texas Oncology - P.A.- Longview
🇺🇸Longview, Texas, United States
Texas Oncology - P.A.-McAllen
🇺🇸McAllen, Texas, United States
Texas Oncology- McKinney
🇺🇸McKinney, Texas, United States
Texas Oncology - P.A.- Midland
🇺🇸Midland, Texas, United States
Texas Oncology - P.A.- Odessa
🇺🇸Odessa, Texas, United States
Texas Oncology - P.A.- Paris
🇺🇸Paris, Texas, United States
Texas Oncology - P.A.- Plano
🇺🇸Plano, Texas, United States
Texas Oncology- Plano West
🇺🇸Plano, Texas, United States
Texas Oncology - P.A.-Sherman
🇺🇸Sherman, Texas, United States
Texas Oncology - Rockwall
🇺🇸Rockwall, Texas, United States
Texas Oncology - P.A.-Sugar Land
🇺🇸Sugar Land, Texas, United States
Tyler Hematology Oncology
🇺🇸Tyler, Texas, United States
Texas Oncology-P.A-Tyler
🇺🇸Tyler, Texas, United States
Texas Oncology, P.A. - Horizon Circle
🇺🇸Waco, Texas, United States
Texas Oncology, P.A. - Waco
🇺🇸Waco, Texas, United States
Texas Oncology-P.A.- Webster
🇺🇸Webster, Texas, United States
Texas Oncology-Weslaco
🇺🇸Weslaco, Texas, United States
Cancer Specialists of Tidewater
🇺🇸Newport News, Virginia, United States
Shenandoah Oncology, P.C.
🇺🇸Winchester, Virginia, United States
Providence Everett Medical Center
🇺🇸Everett, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
🇺🇸Yakima, Washington, United States
ProHealth Care
🇺🇸Waukesha, Wisconsin, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Multicare Institute for Research and Innovation
🇺🇸Tacoma, Washington, United States
Providence St. Mary Regional Cancer Center
🇺🇸Walla Walla, Washington, United States
Compass oncology
🇺🇸Vancouver, Washington, United States
HSHS St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Community Health Network
🇺🇸Indianapolis, Indiana, United States
Investigative Clinical Research of Indiana, LLC
🇺🇸Indianapolis, Indiana, 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
Mercy Research - Mercy Clinic Oncology and Hematology
🇺🇸Oklahoma City, Oklahoma, United States
Arizona Oncology Associates, PC - HAL
🇺🇸Phoenix, Arizona, United States
Rocky Mountain Cancer Centers, LLP
🇺🇸Denver, Colorado, United States
Compass Oncology- Hoyt
🇺🇸Portland, Oregon, United States
Compass Oncology- Barnes
🇺🇸Portland, Oregon, United States
Compass Oncology- Broadway
🇺🇸Portland, Oregon, United States
Meharry Medical College
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Cancer Alliance of Nebraska
🇺🇸Omaha, Nebraska, United States
Rocky Mountain Cancer Centers, LLP- Aurora
🇺🇸Aurora, Colorado, United States
Cancer Specialists, LLC
🇺🇸Jacksonville, Florida, United States
Hematology Oncology Associates of Rockland
🇺🇸Nyack, New York, United States
CCS Oncology
🇺🇸Williamsville, New York, United States
Texas Oncology - Abilene
🇺🇸Abilene, Texas, United States
Texas Oncology- Allen
🇺🇸Allen, Texas, United States
Texas Oncology - Amarillo
🇺🇸Amarillo, Texas, United States
Texas Oncology -P.A.- Mesquite
🇺🇸Mesquite, Texas, United States