informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
informCLL
1 other identifier
observational
1,504
1 country
192
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Longer than P75 for all trials
192 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 8, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2021
CompletedJuly 22, 2022
July 1, 2022
5.9 years
September 8, 2015
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
* 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
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
Secondary Outcomes (2)
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 patient-reported HRQoL scores
up to 7 years
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Diagnosis of B-cell malignancies other than CLL/SLL
- Estimated life expectancy \<6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmacyclics LLC.lead
- Janssen, LPcollaborator
Study Sites (192)
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Northwest Alabama Cancer Center, PC
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
Related Publications (1)
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.
PMID: 18216293BACKGROUND
Related Links
Biospecimen
blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alex Young
Pharmacyclics LLC.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2015
First Posted
October 21, 2015
Study Start
September 1, 2015
Primary Completion
July 21, 2021
Study Completion
July 21, 2021
Last Updated
July 22, 2022
Record last verified: 2022-07