informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia (informCLL)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Lymphocytic Leukemia (CLL)

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.

• Study Type: Observational
• Enrollment (Actual): 1504

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Clearview Cancer Institute
    • Muscle Shoals, Alabama, United States, 35661
      • Northwest Alabama Cancer Center, Pc
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Arizona Oncology Associates, PC - HAL
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology Associates, PC - HAL
    • Phoenix, Arizona, United States, 85027
      • Arizona Oncology Associates, PC - HAL
    • Tempe, Arizona, United States, 85284
      • Arizona Oncology Associates, PC - HAL-Scottsdale
  • Arkansas
    • Fort Smith, Arkansas, United States, 72903
      • Mercy Research
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Center
    • Jonesboro, Arkansas, United States, 72401
      • Clopton Clinic of Jonesboro, Inc.
    • Little Rock, Arkansas, United States, 72205
      • CARTI - Central Arkansas Radiation Therapy Institute
  • California
    • Concord, California, United States, 94520
      • John Muir Health
    • Oceanside, California, United States, 92056
      • North County Oncology Medical Clinic
    • Saint Helena, California, United States, 94574
      • Gregory Smith, MD (Private Practice)
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic
    • Santa Rosa, California, United States, 95403
      • St Joseph Heritage Healthcare
    • Solvang, California, United States, 93463
      • Sansum Clinic
    • Vallejo, California, United States, 94589
      • Solano Hematology Oncology
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers, LLP- Aurora
    • Boulder, Colorado, United States, 80303
      • Rocky Mountain Cancer Centers, LLP- Boulder
    • Colorado Springs, Colorado, United States, 80907
      • Rocky Mountain Cancer Centers
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers, LLP
    • Denver, Colorado, United States, 80220
      • Rocky Mountain Cancer Centers, LLP
    • Lakewood, Colorado, United States, 80228
      • Rocky Mountain Cancer Centers, LLP- Lakewood
    • Littleton, Colorado, United States, 80120-4413
      • Rocky Mountain Cancer Centers, LLP- Littleton
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer Centers, LLP- Sky Ridge
    • Longmont, Colorado, United States, 80501
      • Rocky Mountain Cancer Centers, LLP- Longmont
    • Parker, Colorado, United States, 80138
      • Rocky Mountain Cancer Centers, LLP- Parker
    • Pueblo, Colorado, United States, 81008
      • Rocky Mountain Cancer Centers, LLP- Pueblo
    • Thornton, Colorado, United States, 80260
      • Rocky Mountain Cancer Centers, LLP- Thornton
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • University Cancer Institute, LLC
    • Fort Lauderdale, Florida, United States, 33308
      • Broward Oncology Associates, PA
    • Jacksonville, Florida, United States, 32207
      • Baptist MD Anderson Cancer Center
    • Jacksonville, Florida, United States, 32082
      • Cancer Specialists, LLC
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Health Systems Inc
    • Lakeland, Florida, United States, 33805
      • Watson Clinic Cancer and Research Center
    • Pensacola, Florida, United States, 32504
      • Sacred Heart Cancer Center
  • Georgia
    • Albany, Georgia, United States, 31701
      • Phoebe Putney Memorial Hospital
    • Augusta, Georgia, United States, 30912
      • Georgia Cancer Center at Augusta University
    • Brunswick, Georgia, United States, 31520
      • Southeast Georgia Physician Associates Hematology & Oncology
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Normal, Illinois, United States, 61761
      • Mid-Illinois Hematology & Oncology Associates,Ltd.
    • Peoria, Illinois, United States, 61615-7828
      • Illinois Cancer Care, P.C.
    • Rockford, Illinois, United States, 61108
      • OSF Saint Anthony Medical Center
    • Skokie, Illinois, United States, 60077
      • Orchard Healthcare Research Inc.
    • Tinley Park, Illinois, United States, 60487
      • Healthcare Research Network III, LLC
  • Indiana
    • Anderson, Indiana, United States, 46016
      • St. Vincent Anderson Regional Hospital
    • Indianapolis, Indiana, United States, 46260
      • Investigative Clinical Research of Indiana, LLC
    • Indianapolis, Indiana, United States, 46219
      • Community Health Network
    • Lafayette, Indiana, United States, 47905
      • Horizon Oncology Research, Inc
    • South Bend, Indiana, United States, 46601
      • Memorial Medical Group Clinical Research Institute
    • Vincennes, Indiana, United States, 47591
      • Good Samaritan Hospital
  • Iowa
    • Ames, Iowa, United States, 50010-3014
      • McFarland Clinic, P.C.
    • Cedar Rapids, Iowa, United States, 52402
      • Physicians Clinic of Iowa
    • Waterloo, Iowa, United States, 50702
      • Covenant Clinic
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center, Hematology and Oncology
  • Kentucky
    • Mount Sterling, Kentucky, United States, 40353
      • Montgomery Cancer Center
    • Paducah, Kentucky, United States, 42003
      • West Ky Hematology & Oncology Group, PSC
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Pontchartrain Cancer Center
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
    • Shreveport, Louisiana, United States, 71103
      • Willis-Knighton Cancer Center
    • Shreveport, Louisiana, United States, 71105
      • Christus Cancer Treatment Center
  • Maine
    • Lewiston, Maine, United States, 04240
      • Maine Research Associates
    • Rockport, Maine, United States, 04856
      • Penobscot Bay Medical Center
    • Scarborough, Maine, United States, 04074
      • Maine Center For Cancer Medicine
  • Maryland
    • Cumberland, Maryland, United States, 21502
      • Western Maryland Health System
    • Hagerstown, Maryland, United States, 21740
      • Antietam Oncology and Hematology Group PC
  • Massachusetts
    • Pittsfield, Massachusetts, United States, 01201
      • Berkshire Hematology Oncology, PC
    • Plymouth, Massachusetts, United States, 02360
      • Beth Israel Deaconess Hospital- Plymouth
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center
    • Novi, Michigan, United States, 48374-1233
      • St John Providence Hospital
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • Coborn Cancer Center
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Jackson Oncology Associates
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Central Cancer Care Center
    • Jefferson City, Missouri, United States, 65109
      • Jefferson City Medical Group
    • Saint Joseph, Missouri, United States, 64506
      • Heartland Regional Medical Center d/b/a Cancer Care St. Joseph Mosaic Life Care
  • Montana
    • Billings, Montana, United States, 59102
      • St. Vincent Frontier Cancer Center
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Mary Lanning Healthcare Morrison Cancer Center
    • Lincoln, Nebraska, United States, 68510
      • Southeast Nebraska Cancer Center
    • Lincoln, Nebraska, United States, 68506
      • Nebraska Hematology-Oncology, P.C
    • Omaha, Nebraska, United States, 68106
      • Cancer Alliance of Nebraska
  • New Jersey
    • Elizabeth, New Jersey, United States, 07207
      • Trinitas Hospital
    • Englewood, New Jersey, United States, 07631
      • Hematology Oncology Physicians of Englewood, PA
    • Neptune, New Jersey, United States, 07753
      • Meridian Health Systems
    • New Brunswick, New Jersey, United States, 08901
      • Saint Peter's University Hospital
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital
    • Williamstown, New Jersey, United States, 08360
      • Southern Oncology Hematology Associates
  • New Mexico
    • Farmington, New Mexico, United States, 87401
      • San Juan Oncology Associates
  • New York
    • Bronx, New York, United States, 10469
      • Eastchester Center for Cancer Care
    • East Hills, New York, United States, 11548
      • St. Francis Hospital
    • East Setauket, New York, United States, 11733
      • North Shore Hematology Oncology Associates, PC
    • East Syracuse, New York, United States, 13057
      • Hematology Oncology Associates of Central New York
    • Glens Falls, New York, United States, 12801
      • Glen Falls Hospital Cancer Center
    • Manhasset, New York, United States, 11030
      • North Shore Long Island Jewish Hospital
    • Mount Kisco, New York, United States, 10549
      • Northern Westchester Hospital
    • New York, New York, United States, 10016
      • MHO Research Foundation, Inc.
    • Nyack, New York, United States, 10960
      • Hematology Oncology Associates of Rockland
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical Center
    • White Plains, New York, United States, 10601
      • White Plains Hospital
    • Williamsville, New York, United States, 14221
      • Ccs Oncology
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Waverly Hematology Oncology
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
    • Greenville, North Carolina, United States, 27834
      • Leo Jenkins Cancer Center/ECU School of Medicine
    • Morehead City, North Carolina, United States, 28557
      • Raab Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43219
      • Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center
    • Middletown, Ohio, United States, 45005
      • Wright State University
    • Toledo, Ohio, United States, 43623
      • Toledo Community Hospital Oncology Program - CCOP Toledo
    • Youngstown, Ohio, United States, 44501
      • St. Elizabeth Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Mercy Research - Mercy Clinic Oncology and Hematology
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Willamette Valley Cancer Institute and Research Center
    • Medford, Oregon, United States, 97504
      • Hematology Oncology Associates, PC
    • Medford, Oregon, United States, 97504
      • Hematology Oncology Associates
    • Portland, Oregon, United States, 97213-2982
      • Compass Oncology- Hoyt
    • Portland, Oregon, United States, 97225
      • Compass Oncology- Barnes
    • Portland, Oregon, United States, 97227
      • Compass Oncology- Broadway
    • Springfield, Oregon, United States, 97477
      • Willamette Valley Cancer Institute and Research Center
    • Tualatin, Oregon, United States, 97062
      • Compass Oncology- Tualatin
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17605
      • Lancaster Cancer Center
    • Monroeville, Pennsylvania, United States, 15232
      • University Cancer Institute, LLC
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Medical Center
    • Scranton, Pennsylvania, United States, 18510
      • Hematology & Oncology Associates of Northeastern PA
    • Williamsport, Pennsylvania, United States, 17701
      • Susquehanna Cancer Center
    • York, Pennsylvania, United States, 17403
      • Cancer Care Associates of York
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Charleston Cancer Center
    • Easley, South Carolina, United States, 29640
      • Cancer Centers of the Carolinas- Easley
    • Greenville, South Carolina, United States, 29605
      • Cancer Centers of the Carolinas- Butternut
    • Greenville, South Carolina, United States, 29605
      • Hematology and Oncology Associates of SC, LLC
    • Greenville, South Carolina, United States, 29615
      • Greenville Hospital System Medical Center
    • Greer, South Carolina, United States, 29650
      • Greenville Health System
    • Hilton Head Island, South Carolina, United States, 29926
      • South Carolina Cancer Specialists
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Blood and Cancer Care Associates
    • Seneca, South Carolina, United States, 29672
      • Cancer Centers of the Carolinas - Seneca
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Healthcare System
    • Spartanburg, South Carolina, United States, 29307
      • Cancer Centers of the Carolinas- Spartanburg
  • South Dakota
    • Watertown, South Dakota, United States, 57201
      • Prairie Lakes Hospital
  • Tennessee
    • Cookeville, Tennessee, United States, 38501
      • Cookeville Regional Medical Center
    • Jackson, Tennessee, United States, 38301
      • Jackson Madison County General Hospital
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37208
      • Meharry Medical College
  • Texas
    • Abilene, Texas, United States, 79601
      • Hendrick Cancer Center
    • Abilene, Texas, United States, 79606-5208
      • Texas Oncology - Abilene
    • Allen, Texas, United States, 75013
      • Texas Oncology- Allen
    • Amarillo, Texas, United States, 79106
      • Texas Oncology - Amarillo
    • Arlington, Texas, United States, 76012
      • Texas Oncoogy - Arlington North
    • Arlington, Texas, United States, 76014
      • Texas Oncology- Arlington South
    • Austin, Texas, United States, 78705
      • Texas Oncology - Austin Midtown
    • Austin, Texas, United States, 78731
      • Texas Oncology - P.A.- Austin
    • Austin, Texas, United States, 78745
      • South Austin Cancer Center
    • Beaumont, Texas, United States, 77701
      • Texas Oncology - PA
    • Beaumont, Texas, United States, 77702
      • Texas Oncology, P.A - Beaumont
    • Bedford, Texas, United States, 76022
      • Texas Oncology-Bedford
    • Carrollton, Texas, United States, 75010
      • Texas Oncology - Carrollton
    • Dallas, Texas, United States, 75231
      • Texas Oncology - Dallas Presbyterian
    • Dallas, Texas, United States, 75246
      • Baylor Charles A. Sammons Cancer Center
    • El Paso, Texas, United States, 79902
      • El Paso Cancer Treatment Center- West
    • El Paso, Texas, United States, 79915
      • Texas Oncology - P.A. - El Paso
    • El Paso, Texas, United States, 79939
      • Texas Oncology - El Paso
    • Flower Mound, Texas, United States, 75028
      • Texas Oncology, P.A.- Flower Mound
    • Grapevine, Texas, United States, 76051
      • Texas Oncology-Grapevine
    • Harlingen, Texas, United States, 78550
      • Texas Oncology Pa
    • Longview, Texas, United States, 75601
      • Texas Oncology - P.A.- Longview
    • McAllen, Texas, United States, 78503
      • Texas Oncology - P.A.-McAllen
    • McKinney, Texas, United States, 75071
      • Texas Oncology- Mckinney
    • Mesquite, Texas, United States, 75150
      • Texas Oncology -P.A.- Mesquite
    • Midland, Texas, United States, 79701
      • Texas Oncology - P.A.- Midland
    • Odessa, Texas, United States, 79761
      • Texas Oncology - P.A.- Odessa
    • Paris, Texas, United States, 75460-5004
      • Texas Oncology - P.A.- Paris
    • Plano, Texas, United States, 75075-7787
      • Texas Oncology - P.A.- Plano
    • Plano, Texas, United States, 75093
      • Texas Oncology- Plano West
    • Rockwall, Texas, United States, 75032
      • Texas Oncology - Rockwall
    • San Antonio, Texas, United States, 78212
      • Texas Oncology- San Antonio Downtown
    • San Antonio, Texas, United States, 78217
      • Texas Oncology- San Antonio Northeast
    • San Antonio, Texas, United States, 78258
      • Texas Oncology- San Antonio Stone Oak
    • Sherman, Texas, United States, 75090
      • Texas Oncology - P.A.-Sherman
    • Sugar Land, Texas, United States, 77479
      • Texas Oncology - P.A.-Sugar Land
    • Tyler, Texas, United States, 75701
      • Tyler Hematology Oncology
    • Tyler, Texas, United States, 75702
      • Texas Oncology-P.A-Tyler
    • Waco, Texas, United States, 76712
      • Texas Oncology, P.A. - Horizon Circle
    • Waco, Texas, United States, 76712
      • Texas Oncology, P.A. - Waco
    • Webster, Texas, United States, 77598-4420
      • Texas Oncology-P.A.- Webster
    • Weslaco, Texas, United States, 78596
      • Texas Oncology-Weslaco
  • Virginia
    • Newport News, Virginia, United States, 23601
      • Cancer Specialists of Tidewater
    • Winchester, Virginia, United States, 22601
      • Shenandoah Oncology, P.C.
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Everett Medical Center
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research and Innovation
    • Vancouver, Washington, United States, 98684
      • Compass Oncology
    • Walla Walla, Washington, United States, 99362
      • Providence St. Mary Regional Cancer Center
    • Yakima, Washington, United States, 98902
      • Yakima Valley Memorial Hospital/North Star Lodge
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • HSHS St. Vincent Hospital Regional Cancer Center
    • Waukesha, Wisconsin, United States, 53188
      • ProHealth Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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 Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Pharmacyclics LLC.
• Collaborators: Janssen, LP
• Investigators: Study Director: Alex Young, Pharmacyclics LLC.

Publications and helpful links

General Publications

• 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. Erratum In: Blood. 2008 Dec 15;112(13):5259.

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): July 21, 2021

Study Registration Dates

• First Submitted: September 8, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: CLL; Chronic Lymphocytic Leukemia; SLL; Small Lymphocytic Leukemia
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: PCYC-1134M-CA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No