Clinical trial NCT02582879: informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Official title: informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia (CLL)
Keywords: Chronic Lymphocytic Leukemia
CLL
Small Lymphocytic Leukemia
SLL
Lead sponsor: Pharmacyclics LLC.
Sponsor class: INDUSTRY
Collaborators: name: Janssen, LP
First posted: 2015-10-21
Enrollment: 1504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

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