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

NCT ID: NCT02582879

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1504 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2021-07-21

Brief Summary

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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

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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.

Conditions

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Chronic Lymphocytic Leukemia (CLL)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen, LP

INDUSTRY

Sponsor Role collaborator

Pharmacyclics LLC.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex Young

Role: STUDY_DIRECTOR

Pharmacyclics LLC.

Locations

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Clearview Cancer Institute

Huntsville, Alabama, United States

Site Status

Northwest Alabama Cancer Center, PC

Muscle Shoals, Alabama, United States

Site Status

Arizona Oncology Associates, PC - HAL

Glendale, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HAL

Phoenix, Arizona, United States

Site Status

Arizona Oncology Associates, PC - HAL-Scottsdale

Tempe, Arizona, United States

Site Status

Mercy Research

Fort Smith, Arkansas, United States

Site Status

Genesis Cancer Center

Hot Springs, Arkansas, United States

Site Status

Clopton Clinic of Jonesboro, Inc.

Jonesboro, Arkansas, United States

Site Status

CARTI - Central Arkansas Radiation Therapy Institute

Little Rock, Arkansas, United States

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John Muir Health

Concord, California, United States

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North County Oncology Medical Clinic

Oceanside, California, United States

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Sansum Clinic

Santa Barbara, California, United States

Site Status

St Joseph Heritage Healthcare

Santa Rosa, California, United States

Site Status

Sansum Clinic

Solvang, California, United States

Site Status

Gregory Smith, MD (Private Practice)

St. Helena, California, United States

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Solano Hematology Oncology

Vallejo, California, United States

Site Status

Rocky Mountain Cancer Centers, LLP- Aurora

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP- Boulder

Boulder, Colorado, United States

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Rocky Mountain Cancer Centers

Colorado Springs, Colorado, United States

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Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

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Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

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Rocky Mountain Cancer Centers, LLP- Lakewood

Lakewood, Colorado, United States

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Rocky Mountain Cancer Centers, LLP- Littleton

Littleton, Colorado, United States

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Rocky Mountain Cancer Centers, LLP- Sky Ridge

Lone Tree, Colorado, United States

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Rocky Mountain Cancer Centers, LLP- Longmont

Longmont, Colorado, United States

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Rocky Mountain Cancer Centers, LLP- Parker

Parker, Colorado, United States

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Rocky Mountain Cancer Centers, LLP- Pueblo

Pueblo, Colorado, United States

Site Status

Rocky Mountain Cancer Centers, LLP- Thornton

Thornton, Colorado, United States

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University Cancer Institute, LLC

Boynton Beach, Florida, United States

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Broward Oncology Associates, PA

Fort Lauderdale, Florida, United States

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Cancer Specialists, LLC

Jacksonville, Florida, United States

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Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

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Lakeland Regional Health Systems Inc

Lakeland, Florida, United States

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Watson Clinic Cancer and Research Center

Lakeland, Florida, United States

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Sacred Heart Cancer Center

Pensacola, Florida, United States

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Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Site Status

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Site Status

Southeast Georgia Physician Associates Hematology & Oncology

Brunswick, Georgia, United States

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The University of Chicago

Chicago, Illinois, United States

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Ingalls Memorial Hospital

Harvey, Illinois, United States

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Mid-Illinois Hematology & Oncology Associates,Ltd.

Normal, Illinois, United States

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Illinois Cancer Care, P.C.

Peoria, Illinois, United States

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OSF Saint Anthony Medical Center

Rockford, Illinois, United States

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Orchard Healthcare Research Inc.

Skokie, Illinois, United States

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Healthcare Research Network III, LLC

Tinley Park, Illinois, United States

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St. Vincent Anderson Regional Hospital

Anderson, Indiana, United States

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Community Health Network

Indianapolis, Indiana, United States

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Investigative Clinical Research of Indiana, LLC

Indianapolis, Indiana, United States

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Horizon Oncology Research, Inc

Lafayette, Indiana, United States

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Memorial Medical Group Clinical Research Institute

South Bend, Indiana, United States

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Good Samaritan Hospital

Vincennes, Indiana, United States

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McFarland Clinic, P.C.

Ames, Iowa, United States

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Physicians Clinic of Iowa

Cedar Rapids, Iowa, United States

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Covenant Clinic

Waterloo, Iowa, United States

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

Topeka, Kansas, United States

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Montgomery Cancer Center

Mount Sterling, Kentucky, United States

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West Ky Hematology & Oncology Group, PSC

Paducah, Kentucky, United States

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Pontchartrain Cancer Center

Covington, Louisiana, United States

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Tulane University

New Orleans, Louisiana, United States

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Willis-Knighton Cancer Center

Shreveport, Louisiana, United States

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Christus Cancer Treatment Center

Shreveport, Louisiana, United States

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Maine Research Associates

Lewiston, Maine, United States

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Penobscot Bay Medical Center

Rockport, Maine, United States

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Maine Center for Cancer Medicine

Scarborough, Maine, United States

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Western Maryland Health System

Cumberland, Maryland, United States

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Antietam Oncology and Hematology Group PC

Hagerstown, Maryland, United States

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Berkshire Hematology Oncology, PC

Pittsfield, Massachusetts, United States

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Beth Israel Deaconess Hospital- Plymouth

Plymouth, Massachusetts, United States

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West Michigan Cancer Center

Kalamazoo, Michigan, United States

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St John Providence Hospital

Novi, Michigan, United States

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Coborn Cancer Center

Saint Cloud, Minnesota, United States

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Jackson Oncology Associates

Jackson, Mississippi, United States

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Central Cancer Care Center

Bolivar, Missouri, United States

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Jefferson City Medical Group

Jefferson City, Missouri, United States

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

Saint Joseph, Missouri, United States

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St. Vincent Frontier Cancer Center

Billings, Montana, United States

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Mary Lanning Healthcare Morrison Cancer Center

Hastings, Nebraska, United States

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Nebraska Hematology-Oncology, P.C

Lincoln, Nebraska, United States

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Southeast Nebraska Cancer Center

Lincoln, Nebraska, United States

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Cancer Alliance of Nebraska

Omaha, Nebraska, United States

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Trinitas Hospital

Elizabeth, New Jersey, United States

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Hematology Oncology Physicians of Englewood, PA

Englewood, New Jersey, United States

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Meridian Health Systems

Neptune City, New Jersey, United States

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Saint Peter's University Hospital

New Brunswick, New Jersey, United States

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The Valley Hospital

Paramus, New Jersey, United States

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Southern Oncology Hematology Associates

Williamstown, New Jersey, United States

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San Juan Oncology Associates

Farmington, New Mexico, United States

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St. Francis Hospital

East Hills, New York, United States

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North Shore Hematology Oncology Associates, PC

East Setauket, New York, United States

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Hematology Oncology Associates Of Central New York

East Syracuse, New York, United States

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Glen Falls Hospital Cancer Center

Glens Falls, New York, United States

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North Shore Long Island Jewish Hospital

Manhasset, New York, United States

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Northern Westchester Hospital

Mount Kisco, New York, United States

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MHO Research Foundation, Inc.

New York, New York, United States

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Hematology Oncology Associates of Rockland

Nyack, New York, United States

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SUNY Upstate Medical Center

Syracuse, New York, United States

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Eastchester Center for Cancer Care

The Bronx, New York, United States

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White Plains Hospital

White Plains, New York, United States

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CCS Oncology

Williamsville, New York, United States

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Waverly Hematology Oncology

Cary, North Carolina, United States

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Levine Cancer Institute

Charlotte, North Carolina, United States

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Leo Jenkins Cancer Center/ECU School of Medicine

Greenville, North Carolina, United States

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Raab Clinic

Morehead City, North Carolina, United States

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Cleveland Clinic

Cleveland, Ohio, United States

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

Columbus, Ohio, United States

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Wright State University

Middletown, Ohio, United States

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Toledo Community Hospital Oncology Program - CCOP Toledo

Toledo, Ohio, United States

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St. Elizabeth Hospital

Youngstown, Ohio, United States

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Mercy Research - Mercy Clinic Oncology and Hematology

Oklahoma City, Oklahoma, United States

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Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

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Hematology Oncology Associates, PC

Medford, Oregon, United States

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Hematology Oncology Associates

Medford, Oregon, United States

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Compass Oncology- Hoyt

Portland, Oregon, United States

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Compass Oncology- Barnes

Portland, Oregon, United States

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Compass Oncology- Broadway

Portland, Oregon, United States

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Willamette Valley Cancer Institute and Research Center

Springfield, Oregon, United States

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Compass Oncology- Tualatin

Tualatin, Oregon, United States

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Lancaster Cancer Center

Lancaster, Pennsylvania, United States

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University Cancer Institute, LLC

Monroeville, Pennsylvania, United States

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Einstein Medical Center

Philadelphia, Pennsylvania, United States

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Hematology & Oncology Associates of Northeastern PA

Scranton, Pennsylvania, United States

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Susquehanna Cancer Center

Williamsport, Pennsylvania, United States

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Cancer Care Associates of York

York, Pennsylvania, United States

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Charleston Cancer Center

Charleston, South Carolina, United States

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Cancer Centers of the Carolinas- Easley

Easley, South Carolina, United States

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Cancer Centers of the Carolinas- Butternut

Greenville, South Carolina, United States

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Hematology and Oncology Associates of SC, LLC

Greenville, South Carolina, United States

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Greenville Hospital System Medical Center

Greenville, South Carolina, United States

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Greenville Health System

Greer, South Carolina, United States

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South Carolina Cancer Specialists

Hilton Head Island, South Carolina, United States

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Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, United States

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Cancer Centers of the Carolinas - Seneca

Seneca, South Carolina, United States

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Spartanburg Regional Healthcare System

Spartanburg, South Carolina, United States

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Cancer Centers of the Carolinas- Spartanburg

Spartanburg, South Carolina, United States

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Prairie Lakes Hospital

Watertown, South Dakota, United States

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Cookeville Regional Medical Center

Cookeville, Tennessee, United States

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Jackson Madison County General Hospital

Jackson, Tennessee, United States

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Meharry Medical College

Nashville, Tennessee, United States

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

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Hendrick Cancer Center

Abilene, Texas, United States

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Texas Oncology - Abilene

Abilene, Texas, United States

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Texas Oncology- Allen

Allen, Texas, United States

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Texas Oncology - Amarillo

Amarillo, Texas, United States

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Texas Oncoogy - Arlington North

Arlington, Texas, United States

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Texas Oncology- Arlington South

Arlington, Texas, United States

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Texas Oncology - Austin Midtown

Austin, Texas, United States

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Texas Oncology - P.A.- Austin

Austin, Texas, United States

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South Austin Cancer Center

Austin, Texas, United States

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Texas Oncology - PA

Beaumont, Texas, United States

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Texas Oncology, P.A - Beaumont

Beaumont, Texas, United States

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Texas Oncology-Bedford

Bedford, Texas, United States

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Texas Oncology - Carrollton

Carrollton, Texas, United States

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Texas Oncology - Dallas Presbyterian

Dallas, Texas, United States

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Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

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El Paso Cancer Treatment Center- West

El Paso, Texas, United States

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Texas Oncology - P.A. - El Paso

El Paso, Texas, United States

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Texas Oncology - El Paso

El Paso, Texas, United States

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Texas Oncology, P.A.- Flower Mound

Flower Mound, Texas, United States

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Texas Oncology-Grapevine

Grapevine, Texas, United States

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Texas Oncology PA

Harlingen, Texas, United States

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Texas Oncology - P.A.- Longview

Longview, Texas, United States

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Texas Oncology - P.A.-McAllen

McAllen, Texas, United States

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Texas Oncology- McKinney

McKinney, Texas, United States

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Texas Oncology -P.A.- Mesquite

Mesquite, Texas, United States

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Texas Oncology - P.A.- Midland

Midland, Texas, United States

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Texas Oncology - P.A.- Odessa

Odessa, Texas, United States

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Texas Oncology - P.A.- Paris

Paris, Texas, United States

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Texas Oncology - P.A.- Plano

Plano, Texas, United States

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Texas Oncology- Plano West

Plano, Texas, United States

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Texas Oncology - Rockwall

Rockwall, Texas, United States

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Texas Oncology- San Antonio Downtown

San Antonio, Texas, United States

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Texas Oncology- San Antonio Northeast

San Antonio, Texas, United States

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Texas Oncology- San Antonio Stone Oak

San Antonio, Texas, United States

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Texas Oncology - P.A.-Sherman

Sherman, Texas, United States

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Texas Oncology - P.A.-Sugar Land

Sugar Land, Texas, United States

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Tyler Hematology Oncology

Tyler, Texas, United States

Site Status

Texas Oncology-P.A-Tyler

Tyler, Texas, United States

Site Status

Texas Oncology, P.A. - Horizon Circle

Waco, Texas, United States

Site Status

Texas Oncology, P.A. - Waco

Waco, Texas, United States

Site Status

Texas Oncology-P.A.- Webster

Webster, Texas, United States

Site Status

Texas Oncology-Weslaco

Weslaco, Texas, United States

Site Status

Cancer Specialists of Tidewater

Newport News, Virginia, United States

Site Status

Shenandoah Oncology, P.C.

Winchester, Virginia, United States

Site Status

Providence Everett Medical Center

Everett, Washington, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Multicare Institute for Research and Innovation

Tacoma, Washington, United States

Site Status

Compass oncology

Vancouver, Washington, United States

Site Status

Providence St. Mary Regional Cancer Center

Walla Walla, Washington, United States

Site Status

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, United States

Site Status

HSHS St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Site Status

ProHealth Care

Waukesha, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18216293 (View on PubMed)

Related Links

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Other Identifiers

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PCYC-1134M-CA

Identifier Type: -

Identifier Source: org_study_id

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