Chronic Lymphocytic LeukemiaPhase 3NCT04269902
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
A Phase 3 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by National Cancer Institute (NCI) at 632 sites in 2 countries.
Trial summary
This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 632 sitesin 2 countries
- Study dates
- 2 Mar 2021to 1 Oct 2028
- Phase
- Phase 3
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
Who may be able to join
- Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL. Participants must have been diagnosed within 18 months prior to registration
- Participants must have CLL-International Prognostic Index (CLL-IPI) score >= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities)
- Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within 18 months prior to registration. At minimum, FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
- TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing test is distinct from FISH studies for del(17p)
- Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk factors that totals a score of 4 on the CLL-IPI score and/or has complex cytogenetics completed
- Immunoglobulin heavy chain locus variable (IgVH) gene mutation analysis performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at any time prior to registration)
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- Serum beta-2 microglobulin level must be obtained within 28 days prior to registration
- Participants must not meet any of the IWCLL specified criteria for active CLL therapy
- Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment
- Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
- Prior therapy with anti CD20 monoclonal antibodies is not allowed
- Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved for emergency access use for the prevention or treatment of coronavirus disease 2019 [COVID-19]), or radiotherapy
- Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
- Participants must be >= 18 years of age
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Platelet count >= 100,000/mm^3 within 28 days prior to registration
- Absolute neutrophil count (ANC) >= 1,000/mm^3 within 28 days prior to registration
- Creatinine clearance >= 30mL/min (by Cockcroft Gault) within 28 days prior to registration
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN) within 28 days prior to registration
- Total bilirubin =< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration
- Participants must be able to take oral medications
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within 6 months, localized prostate cancer treated with surgical resection and/or radiation only or requiring no more than chronic hormonal therapy, or prostate cancer with Gleason score ≤ 6, or localized breast cancer treated with surgical resection and/or radiation only or requiring no more than chronic hormonal therapy
- Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor
- Participants must not have cirrhosis
- Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocol therapy with V-O.
- Active infection with hepatitis B or C:
- Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR).
- Latent infection with hepatitis B:
- Latent infection is defined as meeting all of the following criteria:
- Hepatitis B surface antigen positive
- Anti-hepatitis B total core antibody positive
- Anti-hepatitis IgM core antibody undetectable
- Hepatitis B PCR undetectable
- Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O.
- Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis
- Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and surgeries that occur inside the thoracic or abdomino-pelvic cavities. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. If a participant has had a bone marrow biopsy for diagnosis or evaluation of CLL, this will not exclude the participant from registration to the study. If there is a question about whether a surgery is major or minor, this should be discussed with the Study Chair
- Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
- Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5, as venetoclax is extensively metabolized by CYP3A4/5
- Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
- Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification
- Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
- Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
- Participants must agree to have specimens submitted for translational medicine (MRD) as outlined
- Participants must be offered the opportunity to participate in specimen banking for future research as outlined.
- NOTE: With participant's consent, the site must follow through with specimen submission as outlined
- Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must be offered the opportunity to participate in the quality of life assessments. (Those participants who are unable to read and write in English, Spanish, French, German, Russian or Mandarin may be registered to S1925 without contributing to the quality of life portion of the study.)
- Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Who cannot join
None listed.
Trial locations and contacts
632 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
308 sites in 2 countries
United States300 sites, 137 recruiting
- Suspended
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
- Suspended
Hickman Cancer Center
Adrian, Michigan, 49221
- Suspended
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
- Suspended
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Suspended
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Kaiser Permanente-Anaheim
Anaheim, California, 92806
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Ashraf R. Aziz
- Suspended
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
- Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
- Suspended
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
- Suspended
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
- Suspended
Anchorage Oncology Centre
Anchorage, Alaska, 99508
- Suspended
Katmai Oncology Group
Anchorage, Alaska, 99508
- Suspended
Providence Alaska Medical Center
Anchorage, Alaska, 99508
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Aspirus Cancer Care-Antigo-Volm Cancer Center
Antigo, Wisconsin, 54409
Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org
Andrew J. Huang
- Active, not recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
- Active, not recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Suspended
Hematology Oncology Associates of Central New York-Auburn
Auburn, New York, 13021
- Recruiting
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
Site Public Contact, 207-626-4855
Andrew Rogers
- Active, not recruiting
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
- Suspended
The Medical Center of Aurora
Aurora, Colorado, 80012
- Suspended
Rush-Copley Medical Center
Aurora, Illinois, 60504
- Suspended
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814
- Recruiting
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Ashraf R. Aziz
- Suspended
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011
- Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Site Public Contact, 410-955-8804, jhcccro@jhmi.edu
Nina D. Wagner-Johnston
- Active, not recruiting
CommonSpirit Saint Joseph Hospital - Bardstown
Bardstown, Kentucky, 40004
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
Efrat Luttwak
- Active, not recruiting
Hematology/Oncology Clinic PLLC
Baton Rouge, Louisiana, 70809
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Active, not recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
- Recruiting
FHCC Overlake
Bellevue, Washington, 98004
Site Public Contact, 425-454-2148
Jason Comer
- Recruiting
Kaiser Permanente-Bellflower
Bellflower, California, 90706
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Ashraf R. Aziz
- Suspended
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
- Active, not recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Charles W. Drescher
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Site Public Contact, 301-319-2100
Christin Destefano
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Suspended
Saint Vincent Healthcare
Billings, Montana, 59101
- Suspended
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
- Active, not recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
- Active, not recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
- Active, not recruiting
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
- Recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Suspended
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
- Suspended
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org
Andreas K. Klein
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Site Public Contact, 877-442-3324
Inhye E. Ahn
- Active, not recruiting
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
- Active, not recruiting
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Suspended
Bristol Regional Medical Center
Bristol, Tennessee, 37620
- Recruiting
Ballad Health Cancer Care - Bristol
Bristol, Virginia, 24201
Site Public Contact, 423-431-5654, charles.mays@balladhealth.org
Asheesh Shipstone
- Recruiting
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Recruiting
MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine, 04011
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Andrew Rogers
- Recruiting
Mid Coast Hospital
Brunswick, Maine, 04011
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Andrew Rogers
- Active, not recruiting
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802
- Suspended
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
- Active, not recruiting
Saint Anne Hospital
Burien, Washington, 98166
- Suspended
Fairview Ridges Hospital
Burnsville, Minnesota, 55337
- Suspended
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
- Suspended
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, 60527
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Suspended
Cambridge Medical Center
Cambridge, Minnesota, 55008
- Recruiting
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Site Public Contact, 856-325-6757
Tulin Budak-Alpdogan
- Recruiting
Marshall Cancer Center
Cameron Park, California, 95682
Site Public Contact, 530-672-7050, cancerservices@marshallmedical.org
Joseph M. Tuscano
- Recruiting
Hematology Oncology Associates of CNY at Camillus
Camillus, New York, 13031
Site Public Contact, 315-472-7504
Steven M. Duffy
- Active, not recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Active, not recruiting
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708
- Suspended
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Suspended
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
- Active, not recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, 95608
- Active, not recruiting
Mercy San Juan Medical Center
Carmichael, California, 95608
- Suspended
Caro Cancer Center
Caro, Michigan, 48723
- Suspended
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
- Suspended
SIH Cancer Institute
Carterville, Illinois, 62918
- Active, not recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
- Recruiting
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
Site Public Contact, 319-297-2900
Bharat Jenigiri
- Active, not recruiting
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
- Active, not recruiting
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
- Active, not recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
- Suspended
Centralia Oncology Clinic
Centralia, Illinois, 62801
- Suspended
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
- Suspended
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Christopher E. Jensen
- Recruiting
Ralph H Johnson VA Medical Center
Charleston, South Carolina, 29401
Site Public Contact, 843-789-7020, ashley.salvo@va.gov
Oleksandra Lupak
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu
Brian T. Hess
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Saint Luke's Hospital
Chesterfield, Missouri, 63017
Site Public Contact, 314-205-6936
Mark J. Fesler
- Active, not recruiting
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Shuo Ma
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Michael J. Thirman
- Recruiting
Enloe Medical Center
Chico, California, 95926
Site Public Contact, 530-332-4700
Joseph M. Tuscano
- Active, not recruiting
Adena Regional Medical Center
Chillicothe, Ohio, 45601
- Active, not recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
- Active, not recruiting
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
- Active, not recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
- Active, not recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
- Active, not recruiting
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247
- Active, not recruiting
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255
- Active, not recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Suspended
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
- Recruiting
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Brian T. Hill
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Site Public Contact, 866-223-8100, TaussigResearch@ccf.org
Brian T. Hill
- Recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Suspended
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Suspended
Billings Clinic-Cody
Cody, Wyoming, 82414
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Muhammad Raza
- Active, not recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
- Active, not recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907
- Recruiting
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Muhammad Raza
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Seema A. Bhat
- Active, not recruiting
Mount Carmel East Hospital
Columbus, Ohio, 43213
- Suspended
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
- Suspended
Riverside Methodist Hospital
Columbus, Ohio, 43214
- Suspended
Grant Medical Center
Columbus, Ohio, 43215
- Active, not recruiting
The Mark H Zangmeister Center
Columbus, Ohio, 43219
- Active, not recruiting
Mount Carmel Health Center West
Columbus, Ohio, 43222
- Suspended
Doctors Hospital
Columbus, Ohio, 43228
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
Efrat Luttwak
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Suspended
Bay Area Hospital
Coos Bay, Oregon, 97420
- Active, not recruiting
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701
- Recruiting
UC Irvine Health Cancer Center-Newport
Costa Mesa, California, 92627
Site Public Contact, 877-827-8839
Catherine C. Coombs
- Active, not recruiting
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503
- Active, not recruiting
Greater Regional Medical Center
Creston, Iowa, 50801
- Active, not recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
- Recruiting
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307
Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Michael J. Thirman
- Suspended
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
- Recruiting
MaineHealth LincolnHealth Hospital
Damariscotta, Maine, 04543
Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org
Andrew Rogers
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu
Joseph J. Vadakara
- Suspended
Miami Valley Hospital
Dayton, Ohio, 45409
- Active, not recruiting
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
- Active, not recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
- Recruiting
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Suspended
Decatur Memorial Hospital
Decatur, Illinois, 62526
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Robert M. Eisner
- Suspended
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015
- Suspended
Grady Memorial Hospital
Delaware, Ohio, 43015
- Suspended
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, 80204
- Suspended
National Jewish Health-Main Campus
Denver, Colorado, 80206
- Active, not recruiting
The Women's Imaging Center
Denver, Colorado, 80209
- Suspended
AdventHealth Porter
Denver, Colorado, 80210
- Active, not recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Active, not recruiting
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
- Active, not recruiting
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
- Suspended
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218
- Active, not recruiting
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
- Suspended
Rose Medical Center
Denver, Colorado, 80220
- Active, not recruiting
Western Surgical Care
Denver, Colorado, 80220
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Broadlawns Medical Center
Des Moines, Iowa, 50314
Site Public Contact, 515-282-2200
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Suspended
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Recruiting
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org
Elie G. Dib
- Active, not recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Site Public Contact, 800-826-4673, becomingapatient@coh.org
Alexey V. Danilov
- Suspended
Dublin Methodist Hospital
Dublin, Ohio, 43016
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Active, not recruiting
CommonSpirit Cancer Center Mercy
Durango, Colorado, 81301
- Active, not recruiting
Mercy Medical Center
Durango, Colorado, 81301
- Active, not recruiting
Durham VA Medical Center
Durham, North Carolina, 27705
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Site Public Contact, 888-275-3853
Danielle M. Brander
- Recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Henry Ford River District Hospital
East China Township, Michigan, 48054
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Suspended
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
- Recruiting
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057
Site Public Contact, 315-472-7504
Steven M. Duffy
- Active, not recruiting
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Chady A. Leon
- Suspended
Fairview Southdale Hospital
Edina, Minnesota, 55435
- Suspended
STCC at DHR Health Institute for Research and Development
Edinburg, Texas, 78539
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Active, not recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758
- Recruiting
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
Site Public Contact, 630-758-5460, Jrohde@emhc.org
Matthew Siegel
- Suspended
Walter Knox Memorial Hospital
Emmett, Idaho, 83617
- Active, not recruiting
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
- Active, not recruiting
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
- Suspended
Swedish Medical Center
Englewood, Colorado, 80113
- Active, not recruiting
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113
- Active, not recruiting
Saint Elizabeth Hospital
Enumclaw, Washington, 98022
- Active, not recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
- Recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Site Public Contact, 847-570-2109
David L. Grinblatt
- Suspended
Providence Regional Cancer Partnership
Everett, Washington, 98201
- Suspended
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Active, not recruiting
Saint Francis Hospital
Federal Way, Washington, 98003
- Active, not recruiting
Armes Family Cancer Center
Findlay, Ohio, 45840
- Active, not recruiting
Blanchard Valley Hospital
Findlay, Ohio, 45840
- Active, not recruiting
Orion Cancer Care
Findlay, Ohio, 45840
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Suspended
Genesee Hematology Oncology PC
Flint, Michigan, 48503
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Kaiser Permanente-Fontana
Fontana, California, 92335
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Ashraf R. Aziz
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Suspended
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Site Public Contact, eileen.georgi@holy-cross.com
Elie G. Dib
- Suspended
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
- Suspended
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
- Active, not recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
- Active, not recruiting
Unity Hospital
Fridley, Minnesota, 55432
- Suspended
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
- Active, not recruiting
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230
- Active, not recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
- Suspended
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
- Suspended
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Robert M. Eisner
- Recruiting
Glens Falls Hospital
Glens Falls, New York, 12801
Site Public Contact, 518-926-6700
Christopher R. Mason
- Recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
Site Public Contact, 847-570-2109
David L. Grinblatt
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
Shuo Ma
- Suspended
National Jewish Health-Western Hematology Oncology
Golden, Colorado, 80401
- Recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Suspended
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803
- Suspended
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
- Recruiting
Grand Valley Oncology
Grand Junction, Colorado, 81505
Site Public Contact, 970-644-4460, gvoclinicaltrials@gjhosp.org
Jonathan D. King
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Elie G. Dib
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
Shuo Ma
- Suspended
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Suspended
Great Falls Clinic
Great Falls, Montana, 59405
- Suspended
Banner North Colorado Medical Center
Greeley, Colorado, 80631
- Recruiting
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301
Site Public Contact, 920-435-8326
Srinandan Guntupalli
- Active, not recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
- Active, not recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Site Public Contact, 252-744-1015, eubankss@ecu.edu
Darla K. Liles
- Active, not recruiting
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
- Active, not recruiting
Wayne Hospital
Greenville, Ohio, 45331
- Recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Suzanne R. Fanning
- Recruiting
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Site Public Contact, 901-226-1366, BCCclintrials@bmhcc.org
Muhammad Raza
- Recruiting
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Suspended
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236
- Recruiting
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Active, not recruiting
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123
- Recruiting
Kaiser Permanente South Bay
Harbor City, California, 90710
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Ashraf R. Aziz
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
Efrat Luttwak
- Recruiting
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Site Public Contact, 708-915-4673, clinicaltrials@ingalls.org
Ivy Abraham
- Recruiting
HaysMed
Hays, Kansas, 67601
Site Public Contact, 785-623-5774
Marc S. Hoffmann
- Suspended
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
- Recruiting
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
Site Public Contact, 828-696-4716, pardeecancerresearch@unchealth.unc.edu
John K. Hill
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
Site Public Contact, 847-570-2109
David L. Grinblatt
- Suspended
University of North Carolina-Hillsborough Campus
Hillsborough, North Carolina, 27278
- Suspended
Loyola Medicine Homer Glen
Homer Glen, Illinois, 60491
- Suspended
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, 71913
- Recruiting
City of Hope Seacliff
Huntington Beach, California, 92648
Site Public Contact, 626-256-4673
Alexey V. Danilov
- Recruiting
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Site Public Contact, 317-278-5632, iutrials@iu.edu
Rita Assi
- Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Catherine C. Coombs
- Recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Site Public Contact, 877-467-3411
Alexey V. Danilov
- Recruiting
Kaiser Permanente-Irvine
Irvine, California, 92618
Site Public Contact, 800-398-3996, clinical.trials@kp.org
Ashraf R. Aziz
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Charles W. Drescher
- Recruiting
Allegiance Health
Jackson, Michigan, 49201
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Haythem Y. Ali
- Recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Site Public Contact, 910-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Suspended
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
- Suspended
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
- Recruiting
Jersey City Medical Center
Jersey City, New Jersey, 07302
Site Public Contact, 888-823-5923, ctsucontact@westat.com
Joanna M. Rhodes
- Recruiting
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Site Public Contact, 870-936-7066, Emily.Carvell@bmhcc.org
Muhammad Raza
- Suspended
Freeman Health System
Joplin, Missouri, 64804
- Suspended
Mercy Hospital Joplin
Joplin, Missouri, 64804
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
- Suspended
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu
Marc S. Hoffmann
- Recruiting
University Health Truman Medical Center
Kansas City, Missouri, 64108
Site Public Contact, 816-404-4375
Marc S. Hoffmann
Canada8 sites, 4 recruiting
- Active, not recruiting
QEII Health Sciences Centre/Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Site Public Contact, 514-340-8222 ext. 8248
Tanya Skamene
- Active, not recruiting
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
- Active, not recruiting
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6
- Active, not recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
- Recruiting
Atlantic Health Sciences Corporation-Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Site Public Contact, 506-648-6890
Alfonso Rivera Duarte
- Recruiting
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Site Public Contact, 888-939-3333
Alina S. Gerrie
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Site Public Contact, 866-561-1026, ctu_web@cancercare.mb.ca
Versha Banerji
About this study
Official title: Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study
This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate whether early treatment with venetoclax and obinutuzumab (V-O) extends overall survival (OS) compared with delayed treatment with V-O in high-risk (Chronic Lymphocytic Leukemia [CLL] International Prognostic Indicator [CLL-IPI] >= 4 or complex cytogenetics), newly diagnosed asymptomatic CLL/small lymphocytic lymphoma (SLL) participants.
SECONDARY OBJECTIVES:
- To compare overall response rates (complete response [CR] + complete response with incomplete marrow recovery [CRi] + partial response [PR]), CR rates, progression-free survival (PFS), and event-free survival (EFS) between arms.
II. To evaluate safety and tolerability of each arm. III. To compare time to second CLL-directed treatment (from randomization and from response) between arms.
IV. To compare relapse-free survival (RFS) and time to second objective disease progression (PFS2) between arms.
- To compare the rates of Richter's transformation between arms. VI. To describe distribution of Cumulative Illness Rating Scale across the study, in each treatment arm, and to estimate the interaction between the scale and treatment arm and OS.
PATIENT-REPORTED OUTCOMES OBJECTIVES:
- To assess the impact of early intervention with V-O versus delayed therapy with V-O in CLL participants in relation to Health-Related Quality of Life (HRQoL) using the Functional Assessment of Cancer Therapy (FACT)-Leukemia scale.
II. To assess the impact of the two treatment arms on the specific domains of the FACT-Leukemia, including physical, social, emotional, and functional well-being and leukemia-specific HRQoL.
TRANSLATIONAL MEDICINE OBJECTIVES (INTEGRATED):
- To evaluate the prognostic association between OS and measurable residual disease (MRD) undetectable disease state at 15 months after treatment initiation, across and between treatment arms. (Primary) II. To describe the prognostic association between the endpoints RFS and OS and MRD undetectable disease state at all measured time points (cycle [C]7 day[D]1, C9D1, C12D1, and 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, 81, 87, 93, and 99 months after treatment initiation) using landmark analyses, across and between treatment arms. (Secondary) III. To evaluate the prognostic association of MRD undetectable disease state over time in each treatment arm with respect to OS and RFS using time-dependent covariate analyses. (Secondary) IV. To describe the proportion of variation in OS and RFS explained by MRD sampling schemes with the goal of providing information on how much additional variation in OS and RFS is explained by additional MRD sampling for future trial designs. (Secondary) V. To compare the rate of MRD undetectable disease state at 15 months after initiation of treatment between treatment arms. (Secondary) VI. To compare duration of MRD undetectable disease state between treatment arms. (Secondary) VII. To describe associations between pretreatment stimulated karyotype risk, p53 mutation, IGHV mutational analysis, fluorescence in situ hybridization (FISH) for del(13q), del(11q), trisomy 12, and del(17p), and beta-2-microglobulin levels and other biomarkers with OS, PFS, overall and complete response rates, achievement of MRD undetectable disease state, and Richter's transformation. (Secondary) VIII. To describe associations between clinical complete or partial response (by International Workshop on Chronic Lymphocytic Leukemia [IWCLL] 2018 criteria) and response as assessed by MRD status and CT scans at 15 months after treatment initiation. (Secondary)
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (DELAYED V-O): Treatment begins once 2018 IWCLL indications are met. Patients receive obinutuzumab intravenously (IV) on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax orally (PO) once daily (QD) on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration and biopsy during follow-up.
ARM II (EARLY V-O): Treatment begins as soon as eligibility criteria are met. Patients receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration and biopsy during follow-up.
After completion of study treatment, patients are followed up for 10 years after registration.
- Being tested
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Obinutuzumab
- 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.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow biopsy
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
ObinutuzumabBiological
Also called Anti-CD20 Monoclonal Antibody R7159, GA 101, GA-101, GA101
Given IV
Questionnaire AdministrationOther
Ancillary studies
VenetoclaxDrug
Also called ABT 199, ABT-0199, ABT-199, ABT199
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (delayed V-O) | Active comparator | Treatment begins once 2018 IWCLL indications are met. Patients receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration and biopsy during follow-up. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Biological: Obinutuzumab; Other: Questionnaire Administration; Drug: Venetoclax |
| Arm II (early V-O) | Experimental | Treatment begins as soon as eligibility criteria are met. Patients receive obinutuzumab IV on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration and biopsy during follow-up. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Biological: Obinutuzumab; Other: Questionnaire Administration; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The final analysis will use stratified Cox proportional hazards regression stratified by Chronic Lymphocytic Leukemia [CLL] International Prognostic Indicator Risk score status (high risk versus very high risk) with a two-sided alpha of 0.05. The final analysis will occur after 58 OS events have been observed, or at 4 years after accrual completes, whichever occurs first. Under the alternative hypothesis, the final analysis is expected to occur at approximately 7.9 years after study activation (about 3.8 years after accrual completes).
Measured: From the day of registration on study until death from any cause with observations censored on the day of last contact for participants not known to have died, assessed up to 10 years
Functional Assessment of Cancer Therapy (FACT)-Leukemia total score
A single comparison in the FACT-Leukemia total scores between patients randomized to early V-O versus delayed V-O will be conducted at the alpha=.05 level. The analysis of the 2-year FACT-Leukemia Total score will be conducted using multiple linear regression analysis, adjusting for stratification factor and the baseline FACT-Leukemia Total score as covariates. Will also conduct longitudinal modeling of the outcome measures over time.
Measured: At 2 years
Secondary outcomes (7)
Incidence of adverse events
Will utilize the National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0 for toxicity and adverse event reporting.
Measured: Up to 10 years
Overall Response rate
Will be compared using Fisher's exact test.
Measured: Up to 10 years
Progression free survival
Will be estimated using the Kaplan-Meier method and will be compared using log-rank tests and Cox regression models.
Measured: From the day of registration on study until the first of: relapse from complete response, progression, or death from any cause, assessed up to 10 years
Event free survival
Will be estimated using the Kaplan-Meier method and will be compared using log-rank tests and Cox regression models.
Measured: From the day of registration on study until the first of: relapse from complete response, death from any cause, start of new (non-protocol) therapy, or completion of protocol therapy without documentation of complete response, assessed up to 10 years
Relapse free survival
Will be estimated using the Kaplan-Meier method and will be compared using log-rank tests and Cox regression models.
Measured: From the date the participant first achieves complete response until relapse from complete response or death from any cause, assessed up to 10 years
Time to second treatment
Will be defined as the next CLL treatment the patient receives after removal from protocol therapy. Will be estimated using the Kaplan-Meier method and will be compared using log-rank tests and Cox regression models.
Measured: Up to 10 years
Patient compliance
Will be reported descriptively by arm.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start2 Mar 2021
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 247 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Deborah M Stephens, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269902
- Sponsor's protocol ID
- NCI-2020-00752
- Other IDs
- NCI-2020-00752, S1925, S1925, U10CA180888
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2020
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.