Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria:
- 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 12 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 12 months prior to registration. FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
- TP53 mutation status (if completed) must be obtained within 12 months prior to registration
- Immunoglobulin heavy chain locus variable (IgVH) mutational status must be obtained prior to registration (at any time prior to registration)
- Serum beta-2 microglobulin level must be obtained within 28 days prior to registration
- 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 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 requiring no more than chronic hormonal therapy, or localized breast cancer requiring no more than chronic hormonal therapy
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 agree to have specimens submitted for translational medicine (MRD) and specimens must be submitted as outlined
- Participants must be offered participation in banking for future research. With patient's consent, specimens must be submitted as outlined
- Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must agree 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
Exclusion Criteria:
- Participants must not meet any of the IWCLL specified criteria for active CLL therapy
- 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 COVID-19), or radiotherapy
- Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
- Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor
- Participants must not have cirrhosis
- 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 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 patient 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
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Fairbanks Memorial HospitalRecruiting
- Cancer Center at Saint Joseph's
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- Kaiser Permanente-AnaheimRecruiting
- Mission Hope Medical Oncology - Arroyo Grande
- Kaiser Permanente-Baldwin ParkRecruiting
- Kaiser Permanente-BellflowerRecruiting
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Marshall Cancer CenterRecruiting
- UC Irvine Health Cancer Center-NewportRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- Kaiser Permanente-FontanaRecruiting
- Kaiser Permanente - Harbor CityRecruiting
- City of Hope at Huntington BeachRecruiting
- City of Hope at Irvine LennarRecruiting
- Kaiser Permanente-IrvineRecruiting
- UCI Health Laguna HillsRecruiting
- City of Hope Antelope ValleyRecruiting
- City of Hope at Long Beach ElmRecruiting
- Tibor Rubin VA Medical CenterRecruiting
- Kaiser Permanente Los Angeles Medical CenterRecruiting
- Kaiser Permanente West Los AngelesRecruiting
- Fremont - Rideout Cancer CenterRecruiting
- City of Hope Newport BeachRecruiting
- Kaiser Permanente-OntarioRecruiting
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Stanford Cancer Institute Palo Alto
- Kaiser Permanente - Panorama CityRecruiting
- Kaiser Permanente-RiversideRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Kaiser Permanente-San Diego ZionRecruiting
- Pacific Central Coast Health Center-San Luis Obispo
- Kaiser Permanente-San MarcosRecruiting
- Mission Hope Medical Oncology - Santa Maria
- City of Hope UplandRecruiting
- Kaiser Permanente-Woodland HillsRecruiting
- Rocky Mountain Cancer Centers-AuroraRecruiting
- The Medical Center of Aurora
- Boulder Community Foothills Hospital
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Rocky Mountain Cancer Centers - CentennialRecruiting
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Cancer Center of Colorado at Sloan's Lake
- National Jewish Health-Main Campus
- The Women's Imaging Center
- Porter Adventist HospitalRecruiting
- Colorado Blood Cancer InstituteRecruiting
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-MidtownRecruiting
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-RoseRecruiting
- Rose Medical Center
- Western Surgical Care
- Mercy Medical Center
- Southwest Oncology PC
- Mountain Blue Cancer Care Center - Swedish
- Rocky Mountain Cancer Centers - SwedishRecruiting
- Swedish Medical Center
- The Melanoma and Skin Cancer Institute
- National Jewish Health-Western Hematology Oncology
- Saint Mary's Hospital and Regional Medical Center
- Grand Valley OncologyRecruiting
- North Colorado Medical Center
- Good Samaritan Medical Center
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist HospitalRecruiting
- Rocky Mountain Cancer Centers-Sky RidgeRecruiting
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist HospitalRecruiting
- Saint Mary Corwin Medical Center
- National Jewish Health-Northern Hematology Oncology
- Rocky Mountain Cancer Centers-Thornton
- Beebe South Coastal Health CampusRecruiting
- Beebe Medical Center
- Delaware Clinical and Laboratory Physicians PARecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Christiana Care Health System-Christiana Hospital
- Beebe Health CampusRecruiting
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- MedStar Georgetown University HospitalRecruiting
- Holy Cross HospitalRecruiting
- Sacred Heart HospitalRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer ClinicRecruiting
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Rush - Copley Medical CenterRecruiting
- Illinois CancerCare-Bloomington
- Loyola Center for Health at Burr Ridge
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern UniversityRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial Hospital
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Illinois CancerCare-Dixon
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Elmhurst Memorial HospitalRecruiting
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston HospitalRecruiting
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center DelnorRecruiting
- NorthShore University HealthSystem-Glenbrook HospitalRecruiting
- Ingalls Memorial HospitalRecruiting
- NorthShore University HealthSystem-Highland Park HospitalRecruiting
- Loyola Medicine Homer Glen
- Illinois CancerCare-Kewanee Clinic
- Northwestern Medicine Lake Forest HospitalRecruiting
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb
- Good Samaritan Regional Health CenterRecruiting
- Edward Hospital/Cancer CenterRecruiting
- UC Comprehensive Cancer Center at Silver CrossRecruiting
- Cancer Care Center of O'FallonRecruiting
- University of Chicago Medicine-Orland ParkRecruiting
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Edward Hospital/Cancer Center?PlainfieldRecruiting
- Illinois CancerCare-Princeton
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical Center
- Carle Cancer CenterRecruiting
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Illinois CancerCare - Washington
- Rush-Copley Healthcare CenterRecruiting
- Reid HealthRecruiting
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- McFarland Clinic - BooneRecruiting
- Saint Anthony Regional Hospital
- Physicians' Clinic of Iowa PCRecruiting
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical CenterRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer CenterRecruiting
- Trinity Regional Medical Center
- McFarland Clinic - JeffersonRecruiting
- McFarland Clinic - MarshalltownRecruiting
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Saint Joseph London
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Jewish Hospital Medical Center South
- Hematology/Oncology Clinic PLLC
- Ochsner LSU Health Monroe Medical Center
- Tulane University Health Sciences Center
- Ochsner LSU Health Saint Mary's Medical Center
- LSU Health Sciences Center at Shreveport
- Tufts Medical CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Hickman Cancer Center
- Saint Joseph Mercy HospitalRecruiting
- Bronson Battle CreekRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Henry Ford Cancer Institute-Downriver
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Caro Cancer Center
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Henry Ford Macomb Hospital-Clinton Township
- Henry Ford Medical Center-Fairlane
- Henry Ford HospitalRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Helen DeVos Children's Hospital at Spectrum Health
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Academic Hematology Oncology SpecialistsRecruiting
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance Health
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer CenterRecruiting
- Borgess Medical Center
- Sparrow HospitalRecruiting
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Toledo Clinic Cancer Centers-Monroe
- Trinity Health Muskegon HospitalRecruiting
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- Henry Ford Medical Center-Columbus
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer Center
- Newland Medical Associates-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- Spectrum Health Reed City HospitalRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer CenterRecruiting
- Henry Ford Macomb Health Center - Shelby Township
- Ascension Providence Hospitals - SouthfieldRecruiting
- Bhadresh Nayak MD PC-Sterling HeightsRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical CenterRecruiting
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Macomb Hematology Oncology PCRecruiting
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland HospitalRecruiting
- Henry Ford West Bloomfield Hospital
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- University of Michigan Health - WestRecruiting
- Huron Gastroenterology PCRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - Burnsville
- Cambridge Medical Center
- Mercy HospitalRecruiting
- Fairview Southdale Hospital
- Unity Hospital
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Minneapolis VA Medical CenterRecruiting
- Health Partners Inc
- Monticello Cancer Center
- New Ulm Medical Center
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical CenterRecruiting
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Fairview Lakes Medical Center
- Baptist Memorial Hospital and Cancer Center-Golden TriangleRecruiting
- Baptist Cancer Center-GrenadaRecruiting
- Baptist Memorial Hospital and Cancer Center-Union CountyRecruiting
- Baptist Memorial Hospital and Cancer Center-DesotoRecruiting
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Saint Francis Medical CenterRecruiting
- Southeast Cancer Center
- Saint Luke's HospitalRecruiting
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - FarmingtonRecruiting
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital SouthRecruiting
- Siteman Cancer Center-South County
- Missouri Baptist Medical CenterRecruiting
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial HospitalRecruiting
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan HospitalRecruiting
- Missouri Baptist Outpatient Center-Sunset HillsRecruiting
- Mercy Hospital Washington
- Community Hospital of AnacondaRecruiting
- Billings Clinic Cancer CenterRecruiting
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls Clinic
- Kalispell Regional Medical CenterRecruiting
- Saint Patrick Hospital - Community Hospital
- Community Medical HospitalRecruiting
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Saint Elizabeth Regional Medical Center
- Cancer Partners of Nebraska - Pine LakeRecruiting
- Southeast Nebraska Cancer Center - 68th Street PlaceRecruiting
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Midlands Community Hospital
- OptumCare Cancer Care at CharlestonRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Cooper Hospital University Medical CenterRecruiting
- Jersey City Medical CenterRecruiting
- Monmouth Medical Center Southern CampusRecruiting
- Monmouth Medical CenterRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Community Medical CenterRecruiting
- MD Anderson Cancer Center at Cooper-VoorheesRecruiting
- University of New Mexico Cancer CenterRecruiting
- Presbyterian Kaseman HospitalRecruiting
- Memorial Medical Center - Las CrucesRecruiting
- Presbyterian Rust Medical Center/Jorgensen Cancer CenterRecruiting
- Hematology Oncology Associates of Central New York-Auburn
- Memorial Sloan Kettering CommackRecruiting
- Hematology Oncology Associates of Central New York-East SyracuseRecruiting
- Glens Falls HospitalRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Mount Sinai HospitalRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Upstate Cancer Center at OswegoRecruiting
- Rochester General HospitalRecruiting
- University of RochesterRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- Hematology Oncology Associates of Central New York-Onondaga HillRecruiting
- SUNY Upstate Medical Center-Community CampusRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Upstate Cancer Center Hematology Oncology at VeronaRecruiting
- Wilmot Cancer Institute at WebsterRecruiting
- Southeastern Medical Oncology Center-ClintonRecruiting
- Durham VA Medical CenterRecruiting
- Duke University Medical CenterRecruiting
- Southeastern Medical Oncology Center-GoldsboroRecruiting
- Margaret R Pardee Memorial HospitalRecruiting
- Southeastern Medical Oncology Center-JacksonvilleRecruiting
- Vidant Oncology-KenansvilleRecruiting
- Vidant Oncology-KinstonRecruiting
- Vidant Oncology-RichlandsRecruiting
- Indu and Raj Soin Medical Center
- Strecker Cancer Center-BelpreRecruiting
- Saint Elizabeth Boardman Hospital
- Cleveland Clinic Mercy HospitalRecruiting
- Mercy Hematology and Oncology Associates Inc
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Miami Valley Hospital South
- Adena Regional Medical CenterRecruiting
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates IncRecruiting
- Riverside Methodist HospitalRecruiting
- Grant Medical CenterRecruiting
- The Mark H Zangmeister CenterRecruiting
- Mount Carmel Health Center West
- Doctors HospitalRecruiting
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer CenterRecruiting
- Grady Memorial Hospital
- Dublin Methodist Hospital
- Armes Family Cancer CenterRecruiting
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-AtriumRecruiting
- Central Ohio Breast and Endocrine Surgery
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Mount Carmel Grove City Hospital
- Greater Dayton Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- Fairfield Medical Center
- Saint Rita's Medical Center
- OhioHealth Mansfield Hospital
- Marietta Memorial HospitalRecruiting
- OhioHealth Marion General HospitalRecruiting
- Hillcrest Hospital Cancer CenterRecruiting
- Knox Community Hospital
- Licking Memorial HospitalRecruiting
- Newark Radiation Oncology
- Mercy Health Perrysburg Cancer Center
- Southern Ohio Medical CenterRecruiting
- Springfield Regional Cancer CenterRecruiting
- Springfield Regional Medical Center
- ProMedica Flower HospitalRecruiting
- Saint Vincent Mercy Medical Center
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-ToledoRecruiting
- Dayton Physicians LLC - Troy
- Upper Valley Medical Center
- Saint Joseph Warren Hospital
- Saint Ann's Hospital
- Wright-Patterson Medical CenterRecruiting
- Saint Elizabeth Youngstown Hospital
- Genesis Healthcare System Cancer Care CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma City
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology CenterRecruiting
- Providence Cancer Institute Clackamas ClinicRecruiting
- Bay Area Hospital
- Providence Newberg Medical CenterRecruiting
- Saint Alphonsus Medical Center-OntarioRecruiting
- Providence Willamette Falls Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Christiana Care Health System-Concord Health Center
- Geisinger Medical CenterRecruiting
- Pocono Medical Center
- Lehigh Valley Hospital-Hazleton
- Thomas Jefferson University HospitalRecruiting
- Jefferson Torresdale HospitalRecruiting
- University of Pittsburgh Cancer Institute (UPCI)
- Medical University of South CarolinaRecruiting
- Bristol Regional Medical Center
- Ballad Health Cancer Care - KingsportRecruiting
- Wellmont Holston Valley Hospital and Medical Center
- Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- Saint Joseph Regional Cancer Center
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- STCC at DHR Health Institute for Research and DevelopmentRecruiting
- UT Southwestern Clinical Center at Richardson/PlanoRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- Wellmont Medical Associates-BristolRecruiting
- Southwest VA Regional Cancer CenterRecruiting
- Providence Regional Cancer System-Aberdeen
- FHCC OverlakeRecruiting
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-BremertonRecruiting
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-EdmondsRecruiting
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-IssaquahRecruiting
- Kadlec Clinic Hematology and OncologyRecruiting
- Seattle Cancer Care Alliance at EvergreenHealthRecruiting
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Jefferson HealthcareRecruiting
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- FHCC South Lake Union
- Fred Hutchinson Cancer Research Center
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First HillRecruiting
- FHCC at Northwest HospitalRecruiting
- University of Washington Medical Center - Montlake
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- Franciscan Research Center-Northwest Medical Plaza
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial HospitalRecruiting
- Providence Regional Cancer System-Yelm
- ThedaCare Regional Cancer CenterRecruiting
- HSHS Sacred Heart HospitalRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Cancer Center of Western Wisconsin
- Saint Vincent Hospital Cancer Center at Oconto FallsRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Saint Vincent Hospital Cancer Center at SheboyganRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Marshfield Medical Center - WestonRecruiting
- Cheyenne Regional Medical Center-West
- Billings Clinic-Cody
- Welch Cancer Center
- BCCA-Vancouver Cancer CentreRecruiting
- CancerCare ManitobaRecruiting
- Atlantic Health Sciences Corporation-Saint John Regional HospitalRecruiting
- Ottawa Hospital and Cancer Center-General CampusRecruiting
- Jewish General HospitalRecruiting
- Allan Blair Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (delayed V-O)
Arm II (early V-O)
Treatment begins once 2018 IWCLL indications are met. Patients receive obinutuzumab IV over 4 hours 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 throughout the trial.
Treatment begins as soon as eligibility criteria are met. Patients receive obinutuzumab IV over 4 hours 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 throughout the trial.