AzTrials
AzTrials

Chronic Lymphocytic Leukemia (CLL)informCLLNCT02582879

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

An observational study of Chronic Lymphocytic Leukemia (CLL), run by Pharmacyclics LLC. at 192 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia (CLL)
Type of treatment
Pill or oral medicine
How many people
1,504 participants
Where
192 sitesUnited States
Study dates
Sep 2015to 21 Jul 2021
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

192 sites in 1 country.

192 sites in 1 country

United States192 sites

  • Hendrick Cancer Center

    Abilene, Texas, 79601

  • Texas Oncology - Abilene

    Abilene, Texas, 79606-5208

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Texas Oncology- Allen

    Allen, Texas, 75013

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106

  • McFarland Clinic, P.C.

    Ames, Iowa, 50010-3014

  • St. Vincent Anderson Regional Hospital

    Anderson, Indiana, 46016

  • Texas Oncoogy - Arlington North

    Arlington, Texas, 76012

  • Texas Oncology- Arlington South

    Arlington, Texas, 76014

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • Rocky Mountain Cancer Centers, LLP- Aurora

    Aurora, Colorado, 80012

  • Texas Oncology - Austin Midtown

    Austin, Texas, 78705

  • Texas Oncology - P.A.- Austin

    Austin, Texas, 78731

  • South Austin Cancer Center

    Austin, Texas, 78745

  • Texas Oncology - PA

    Beaumont, Texas, 77701

  • Texas Oncology, P.A - Beaumont

    Beaumont, Texas, 77702

  • Texas Oncology-Bedford

    Bedford, Texas, 76022

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Central Cancer Care Center

    Bolivar, Missouri, 65613

  • Rocky Mountain Cancer Centers, LLP- Boulder

    Boulder, Colorado, 80303

  • University Cancer Institute, LLC

    Boynton Beach, Florida, 33426

  • Southeast Georgia Physician Associates Hematology & Oncology

    Brunswick, Georgia, 31520

  • Texas Oncology - Carrollton

    Carrollton, Texas, 75010

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Physicians Clinic of Iowa

    Cedar Rapids, Iowa, 52402

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • The University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80907

  • Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • John Muir Health

    Concord, California, 94520

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Pontchartrain Cancer Center

    Covington, Louisiana, 70433

  • Western Maryland Health System

    Cumberland, Maryland, 21502

  • Texas Oncology - Dallas Presbyterian

    Dallas, Texas, 75231

  • Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado, 80220

  • Cancer Centers of the Carolinas- Easley

    Easley, South Carolina, 29640

  • St. Francis Hospital

    East Hills, New York, 11548

  • North Shore Hematology Oncology Associates, PC

    East Setauket, New York, 11733

  • Hematology Oncology Associates Of Central New York

    East Syracuse, New York, 13057

  • El Paso Cancer Treatment Center- West

    El Paso, Texas, 79902

  • Texas Oncology - P.A. - El Paso

    El Paso, Texas, 79915

  • Texas Oncology - El Paso

    El Paso, Texas, 79939

  • Trinitas Hospital

    Elizabeth, New Jersey, 07207

  • Hematology Oncology Physicians of Englewood, PA

    Englewood, New Jersey, 07631

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Providence Everett Medical Center

    Everett, Washington, 98201

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Texas Oncology, P.A.- Flower Mound

    Flower Mound, Texas, 75028

  • Broward Oncology Associates, PA

    Fort Lauderdale, Florida, 33308

  • Mercy Research

    Fort Smith, Arkansas, 72903

  • Arizona Oncology Associates, PC - HAL

    Glendale, Arizona, 85308

  • Glen Falls Hospital Cancer Center

    Glens Falls, New York, 12801

  • Texas Oncology-Grapevine

    Grapevine, Texas, 76051

  • HSHS St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54301

  • Leo Jenkins Cancer Center/ECU School of Medicine

    Greenville, North Carolina, 27834

  • Cancer Centers of the Carolinas- Butternut

    Greenville, South Carolina, 29605

  • Hematology and Oncology Associates of SC, LLC

    Greenville, South Carolina, 29605

  • Greenville Hospital System Medical Center

    Greenville, South Carolina, 29615

  • Greenville Health System

    Greer, South Carolina, 29650

  • Antietam Oncology and Hematology Group PC

    Hagerstown, Maryland, 21740

  • Texas Oncology PA

    Harlingen, Texas, 78550

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Mary Lanning Healthcare Morrison Cancer Center

    Hastings, Nebraska, 68901

  • South Carolina Cancer Specialists

    Hilton Head Island, South Carolina, 29926

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Community Health Network

    Indianapolis, Indiana, 46219

  • Investigative Clinical Research of Indiana, LLC

    Indianapolis, Indiana, 46260

  • Jackson Oncology Associates

    Jackson, Mississippi, 39202

  • Jackson Madison County General Hospital

    Jackson, Tennessee, 38301

  • Cancer Specialists, LLC

    Jacksonville, Florida, 32082

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109

  • Clopton Clinic of Jonesboro, Inc.

    Jonesboro, Arkansas, 72401

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Horizon Oncology Research, Inc

    Lafayette, Indiana, 47905

  • Lakeland Regional Health Systems Inc

    Lakeland, Florida, 33805

  • Watson Clinic Cancer and Research Center

    Lakeland, Florida, 33805

  • Rocky Mountain Cancer Centers, LLP- Lakewood

    Lakewood, Colorado, 80228

  • Lancaster Cancer Center

    Lancaster, Pennsylvania, 17605

  • Maine Research Associates

    Lewiston, Maine, 04240

  • Nebraska Hematology-Oncology, P.C

    Lincoln, Nebraska, 68506

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • CARTI - Central Arkansas Radiation Therapy Institute

    Little Rock, Arkansas, 72205

  • Rocky Mountain Cancer Centers, LLP- Littleton

    Littleton, Colorado, 80120-4413

  • Rocky Mountain Cancer Centers, LLP- Sky Ridge

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers, LLP- Longmont

    Longmont, Colorado, 80501

  • Texas Oncology - P.A.- Longview

    Longview, Texas, 75601

  • North Shore Long Island Jewish Hospital

    Manhasset, New York, 11030

  • Texas Oncology - P.A.-McAllen

    McAllen, Texas, 78503

  • Texas Oncology- McKinney

    McKinney, Texas, 75071

  • Hematology Oncology Associates, PC

    Medford, Oregon, 97504

  • Hematology Oncology Associates

    Medford, Oregon, 97504

  • Texas Oncology -P.A.- Mesquite

    Mesquite, Texas, 75150

  • Wright State University

    Middletown, Ohio, 45005

  • Texas Oncology - P.A.- Midland

    Midland, Texas, 79701

  • University Cancer Institute, LLC

    Monroeville, Pennsylvania, 15232

  • Raab Clinic

    Morehead City, North Carolina, 28557

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Montgomery Cancer Center

    Mount Sterling, Kentucky, 40353

  • Northwest Alabama Cancer Center, PC

    Muscle Shoals, Alabama, 35661

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Meridian Health Systems

    Neptune City, New Jersey, 07753

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Tulane University

    New Orleans, Louisiana, 70112

  • MHO Research Foundation, Inc.

    New York, New York, 10016

  • Cancer Specialists of Tidewater

    Newport News, Virginia, 23601

  • Mid-Illinois Hematology & Oncology Associates,Ltd.

    Normal, Illinois, 61761

  • St John Providence Hospital

    Novi, Michigan, 48374-1233

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • North County Oncology Medical Clinic

    Oceanside, California, 92056

  • Texas Oncology - P.A.- Odessa

    Odessa, Texas, 79761

  • Mercy Research - Mercy Clinic Oncology and Hematology

    Oklahoma City, Oklahoma, 73120

  • Cancer Alliance of Nebraska

    Omaha, Nebraska, 68106

  • West Ky Hematology & Oncology Group, PSC

    Paducah, Kentucky, 42003

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Texas Oncology - P.A.- Paris

    Paris, Texas, 75460-5004

  • Rocky Mountain Cancer Centers, LLP- Parker

    Parker, Colorado, 80138

  • Sacred Heart Cancer Center

    Pensacola, Florida, 32504

  • Illinois Cancer Care, P.C.

    Peoria, Illinois, 61615-7828

  • Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85016

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85027

  • Berkshire Hematology Oncology, PC

    Pittsfield, Massachusetts, 01201

  • Texas Oncology - P.A.- Plano

    Plano, Texas, 75075-7787

  • Texas Oncology- Plano West

    Plano, Texas, 75093

  • Beth Israel Deaconess Hospital- Plymouth

    Plymouth, Massachusetts, 02360

  • Compass Oncology- Hoyt

    Portland, Oregon, 97213-2982

  • Compass Oncology- Barnes

    Portland, Oregon, 97225

  • Compass Oncology- Broadway

    Portland, Oregon, 97227

  • Rocky Mountain Cancer Centers, LLP- Pueblo

    Pueblo, Colorado, 81008

  • Carolina Blood and Cancer Care Associates

    Rock Hill, South Carolina, 29732

  • OSF Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Penobscot Bay Medical Center

    Rockport, Maine, 04856

  • Texas Oncology - Rockwall

    Rockwall, Texas, 75032

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Heartland Regional Medical Center d/b/a Cancer Care St. Joseph Mosaic Life Care

    Saint Joseph, Missouri, 64506

  • Texas Oncology- San Antonio Downtown

    San Antonio, Texas, 78212

  • Texas Oncology- San Antonio Northeast

    San Antonio, Texas, 78217

  • Texas Oncology- San Antonio Stone Oak

    San Antonio, Texas, 78258

  • Sansum Clinic

    Santa Barbara, California, 93105

  • St Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • Maine Center for Cancer Medicine

    Scarborough, Maine, 04074

  • Hematology & Oncology Associates of Northeastern PA

    Scranton, Pennsylvania, 18510

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Cancer Centers of the Carolinas - Seneca

    Seneca, South Carolina, 29672

  • Texas Oncology - P.A.-Sherman

    Sherman, Texas, 75090

  • Willis-Knighton Cancer Center

    Shreveport, Louisiana, 71103

  • Christus Cancer Treatment Center

    Shreveport, Louisiana, 71105

  • Orchard Healthcare Research Inc.

    Skokie, Illinois, 60077

  • Sansum Clinic

    Solvang, California, 93463

  • Memorial Medical Group Clinical Research Institute

    South Bend, Indiana, 46601

  • Spartanburg Regional Healthcare System

    Spartanburg, South Carolina, 29303

  • Cancer Centers of the Carolinas- Spartanburg

    Spartanburg, South Carolina, 29307

  • Willamette Valley Cancer Institute and Research Center

    Springfield, Oregon, 97477

  • Gregory Smith, MD (Private Practice)

    St. Helena, California, 94574

  • Texas Oncology - P.A.-Sugar Land

    Sugar Land, Texas, 77479

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210

  • Multicare Institute for Research and Innovation

    Tacoma, Washington, 98405

  • Arizona Oncology Associates, PC - HAL-Scottsdale

    Tempe, Arizona, 85284

  • Eastchester Center for Cancer Care

    The Bronx, New York, 10469

  • Rocky Mountain Cancer Centers, LLP- Thornton

    Thornton, Colorado, 80260

  • Healthcare Research Network III, LLC

    Tinley Park, Illinois, 60487

  • Toledo Community Hospital Oncology Program - CCOP Toledo

    Toledo, Ohio, 43623

  • Cotton-O'Neil Clinical Research Center, Hematology and Oncology

    Topeka, Kansas, 66606

  • Compass Oncology- Tualatin

    Tualatin, Oregon, 97062

  • Tyler Hematology Oncology

    Tyler, Texas, 75701

  • Texas Oncology-P.A-Tyler

    Tyler, Texas, 75702

  • Solano Hematology Oncology

    Vallejo, California, 94589

  • Compass oncology

    Vancouver, Washington, 98684

  • Good Samaritan Hospital

    Vincennes, Indiana, 47591

  • Texas Oncology, P.A. - Horizon Circle

    Waco, Texas, 76712

  • Texas Oncology, P.A. - Waco

    Waco, Texas, 76712

  • Providence St. Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • Covenant Clinic

    Waterloo, Iowa, 50702

  • Prairie Lakes Hospital

    Watertown, South Dakota, 57201

  • ProHealth Care

    Waukesha, Wisconsin, 53188

  • Texas Oncology-P.A.- Webster

    Webster, Texas, 77598-4420

  • Texas Oncology-Weslaco

    Weslaco, Texas, 78596

  • White Plains Hospital

    White Plains, New York, 10601

  • Susquehanna Cancer Center

    Williamsport, Pennsylvania, 17701

  • Southern Oncology Hematology Associates

    Williamstown, New Jersey, 08360

  • CCS Oncology

    Williamsville, New York, 14221

  • Shenandoah Oncology, P.C.

    Winchester, Virginia, 22601

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington, 98902

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

  • St. Elizabeth Hospital

    Youngstown, Ohio, 44501

Other trials in United States

About this study

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.

Read the 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.

Keywords
Chronic Lymphocytic Leukemia, CLL, Small Lymphocytic Leukemia, SLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02582879
Study groupRoleWhat they receive
Patient with CLL/SLLPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Summarize baseline characteristics of study population, among CLL patients in a real-world setting

    • Summarize baseline characteristics of study participants

    Measured: up to 7 years

  2. 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

    Measured: up to 7 years

  3. 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

    Measured: up to 7 years

  4. Summarize health care resource utilization among CLL patients in a real-world setting

    • Summarize health care resource utilization among study participants

    Measured: up to 7 years

Secondary outcomes (2)

  1. 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

    Measured: up to 7 years

  2. 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

    Measured: up to 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion21 Jul 2021
  4. Study completion21 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,504 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02582879
Sponsor's protocol ID
PCYC-1134M-CA
Acronym
informCLL
Status last verified
Jul 2022
First submitted
8 Sep 2015
Last updated
22 Jul 2022
Results posted
No
Data monitoring committee
No

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.

    PubMed 18216293

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia (CLL), run by Pharmacyclics LLC. at 192 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summarize baseline characteristics of study population, among CLL patients in a real-world setting (time frame: up to 7 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02582879, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in