Taking people in United StatesPhase 3

Testing stopping versus continuing zanubrutinib in older adults with mantle cell lymphoma

Tests zanubrutinib, stopped or continued, in older adults with untreated mantle cell lymphoma.

Plain-language title generated from the registry record
Registry title: Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma

Key facts

Where: Albany, Ames, Anaconda, Ankeny, Ann Arbor, Appleton, Ashland, Atlanta, Augusta, Bay City, Bellevue, Bemidji, Beverly Hills, Billings, Bismarck, Bloomington, Boiling Springs, Boise, Boone, Bozeman, Brainerd, Brighton, Buffalo, Caldwell, Camillus, Canton, Cape Girardeau, Carroll, Carthage, Chapel Hill, Charleston, Chelsea, Chesterfield, Chicago, City of Saint Peters, Clarkston, Clive, Coeur d'Alene, Columbus, Coon Rapids, Creve Coeur, Crown Point, Danville, Decatur, Deer River, Derby, Des Moines, Detroit, Dixon, Duarte, Duluth, Durham, Dyer, Easley, East Syracuse, Eau Claire, Edina, Edmonds, Effingham, Eureka, Evanston, Fairfield, Fargo, Farmington Hills, Flint, Fort Dodge, Fruitland, Galesburg, Glastonbury, Glenview, Great Falls, Greenville, Greenwich, Greer, Guilford, Hartford, Hays, Hibbing, Highland Park, Hobart, Indianapolis, Iowa City, Irvine, Issaquah, Jefferson, Johns Creek, Johnson Creek, Kalispell, Kansas City, Kearney, Kewanee, La Crosse, Lansing, Lapeer, Lawrence, Lawton, Leavenworth, Lebanon, Lee's Summit, Little Rock, Livonia, Los Angeles, Louisville, Macomb, Madison, Maplewood, Marshalltown, Marshfield, Mattoon, Meridian, Milwaukee, Mineola, Minneapolis, Minocqua, Missoula, Mount Pleasant, Mount Vernon, Mukwonago, Munster, Nampa, New Berlin, New Haven, New York, Newark, Newberg, North Haven, North Kansas City, O'Fallon, Oconomowoc, Oklahoma City, Olathe, Omaha, Ontario, Oregon City, Ottawa, Overland Park, Pekin, Peoria, Peru, Petoskey, Pittsburg, Pontiac, Portland, Post Falls, Princeton, Providence, Rice Lake, Richmond, Rochester, Royal Oak, Saginaw, Saint Cloud, Saint Johnsbury, Saint Louis Park, Saint Paul, Salina, Salt Lake City, Sandpoint, Sandstone, Seattle, Seneca, Shiloh, Sioux Falls, Springfield, St Louis, Stamford, Stevens Point, Tawas City, Topeka, Torrington, Troy, Trumbull, Tulsa, Urbana, Valparaiso, Virginia, Washington, Waterbury, Waterford, Waukee, Waukesha, Webster, West Branch, Westerly, Weston, Westwood, Woodbury, and Ypsilanti, United StatesSee the 242 sites
Phase: Phase 3

Where in United States

Phoebe Putney Memorial HospitalAlbany, United StatesTaking people
Mary Greeley Medical CenterAmes, United StatesTaking people
McFarland Clinic - AmesAmes, United StatesTaking people
Community Hospital of AnacondaAnaconda, United StatesTaking people
UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesTaking people
Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn Arbor, United StatesTaking people
ThedaCare Regional Cancer CenterAppleton, United StatesTaking people
ThedaCare Regional Medical Center - AppletonAppleton, United StatesTaking people
Duluth Clinic AshlandAshland, United StatesTaking people
Emory Saint Joseph's HospitalAtlanta, United StatesTaking people
Emory University Hospital MidtownAtlanta, United StatesTaking people
Emory University Hospital/Winship Cancer InstituteAtlanta, United StatesTaking people
Grady Health SystemAtlanta, United StatesTaking people
Augusta University Medical CenterAugusta, United StatesTaking people
McLaren Cancer Institute-Bay CityBay City, United StatesTaking people
Nebraska Medicine-BellevueBellevue, United StatesTaking people
Sanford Joe Lueken Cancer CenterBemidji, United StatesTaking people
Tower Cancer Research FoundationBeverly Hills, United StatesTaking people
Billings Clinic Cancer CenterBillings, United StatesTaking people
Sanford Bismarck Medical CenterBismarck, United StatesTaking people
Illinois CancerCare-BloomingtonBloomington, United StatesTaking people
Prisma Health Cancer Institute - SpartanburgBoiling Springs, United StatesTaking people
Saint Alphonsus Cancer Care Center-BoiseBoise, United StatesTaking people
Saint Luke's Cancer Institute - BoiseBoise, United StatesTaking people
McFarland Clinic - BooneBoone, United StatesNo longer taking part
Bozeman Health Deaconess HospitalBozeman, United StatesTaking people
Essentia Health Saint Joseph's Medical CenterBrainerd, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, United StatesTaking people
Trinity Health Medical Center - BrightonBrighton, United StatesTaking people
Roswell Park Cancer InstituteBuffalo, United StatesTaking people
Saint Alphonsus Cancer Care Center-CaldwellCaldwell, United StatesTaking people
Hematology Oncology Associates of CNY at CamillusCamillus, United StatesTaking people
Illinois CancerCare-CantonCanton, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - CantonCanton, United StatesTaking people
Trinity Health Medical Center - CantonCanton, United StatesTaking people
Saint Francis Medical CenterCape Girardeau, United StatesTaking people
Saint Anthony Regional HospitalCarroll, United StatesTaking people
Illinois CancerCare-CarthageCarthage, United StatesTaking people
UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesTaking people
Medical University of South CarolinaCharleston, United StatesTaking people
Chelsea HospitalChelsea, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelsea, United StatesTaking people
Saint Luke's HospitalChesterfield, United StatesTaking people
Alliance for Clinical Trials in OncologyChicago, United StatesTaking people
University of IllinoisChicago, United StatesTaking people
Siteman Cancer Center at Saint Peters HospitalCity of Saint Peters, United StatesTaking people
McLaren Cancer Institute-ClarkstonClarkston, United StatesTaking people
UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United StatesTaking people
Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesTaking people
Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
Mercy HospitalCoon Rapids, United StatesTaking people
Siteman Cancer Center at West County HospitalCreve Coeur, United StatesTaking people
Northwest Cancer Center - Crown PointCrown Point, United StatesTaking people
Carle at The RiverfrontDanville, United StatesTaking people
Cancer Care Specialists of Illinois - DecaturDecatur, United StatesTaking people
Decatur Memorial HospitalDecatur, United StatesTaking people
Essentia Health - Deer River ClinicDeer River, United StatesTaking people
Smilow Cancer Hospital-Derby Care CenterDerby, United StatesTaking people
Broadlawns Medical CenterDes Moines, United StatesTaking people
Iowa Methodist Medical CenterDes Moines, United StatesTaking people
Mercy Medical Center - Des MoinesDes Moines, United StatesTaking people
UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United StatesTaking people
UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United StatesTaking people
Wayne State University/Karmanos Cancer InstituteDetroit, United StatesTaking people
Illinois CancerCare-DixonDixon, United StatesTaking people
City of Hope Comprehensive Cancer CenterDuarte, United StatesNo longer taking part
Essentia Health Cancer CenterDuluth, United StatesTaking people
Duke University Medical CenterDurham, United StatesTaking people
Northwest Oncology LLCDyer, United StatesTaking people
Prisma Health Cancer Institute - EasleyEasley, United StatesTaking people
Hematology Oncology Associates of Central New York-East SyracuseEast Syracuse, United StatesTaking people
Marshfield Medical Center-EC Cancer CenterEau Claire, United StatesTaking people
Minnesota Oncology - EdinaEdina, United StatesTaking people
Swedish Cancer Institute-EdmondsEdmonds, United StatesTaking people
Carle Physician Group-EffinghamEffingham, United StatesTaking people
Crossroads Cancer CenterEffingham, United StatesTaking people
Illinois CancerCare-EurekaEureka, United StatesTaking people
NorthShore University HealthSystem-Evanston HospitalEvanston, United StatesTaking people
Smilow Cancer Hospital Care Center-FairfieldFairfield, United StatesTaking people
Essentia Health Cancer Center-South University ClinicFargo, United StatesTaking people
Sanford Broadway Medical CenterFargo, United StatesTaking people
Sanford Roger Maris Cancer CenterFargo, United StatesTaking people
Corewell Health Farmington Hills HospitalFarmington Hills, United StatesTaking people
Weisberg Cancer Treatment CenterFarmington Hills, United StatesTaking people
Cancer Hematology Centers - FlintFlint, United StatesTaking people
Genesys Hurley Cancer InstituteFlint, United StatesTaking people
Hurley Medical CenterFlint, United StatesTaking people
McLaren Cancer Institute-FlintFlint, United StatesTaking people
Genesee Hematology Oncology PCFlint, United StatesNo longer taking part
McFarland Clinic - Trinity Cancer CenterFort Dodge, United StatesTaking people
UI Healthcare Mission Cancer and Blood - Fort DodgeFort Dodge, United StatesTaking people
Saint Luke's Cancer Institute - FruitlandFruitland, United StatesTaking people
Illinois CancerCare-GalesburgGalesburg, United StatesTaking people
Smilow Cancer Hospital Care Center at GlastonburyGlastonbury, United StatesTaking people
NorthShore University HealthSystem-Glenbrook HospitalGlenview, United StatesTaking people
Benefis Sletten Cancer InstituteGreat Falls, United StatesTaking people
Prisma Health Cancer Institute - ButternutGreenville, United StatesTaking people
Prisma Health Cancer Institute - EastsideGreenville, United StatesTaking people
Prisma Health Cancer Institute - FarisGreenville, United StatesTaking people
Smilow Cancer Hospital Care Center at GreenwichGreenwich, United StatesTaking people
Prisma Health Cancer Institute - GreerGreer, United StatesTaking people
Smilow Cancer Hospital Care Center - GuilfordGuilford, United StatesTaking people
Smilow Cancer Hospital Care Center at Saint FrancisHartford, United StatesTaking people
HaysMedHays, United StatesTaking people
Essentia Health Hibbing ClinicHibbing, United StatesTaking people
NorthShore University HealthSystem-Highland Park HospitalHighland Park, United StatesTaking people
Northwest Cancer Center - HobartHobart, United StatesTaking people
Saint Mary Medical CenterHobart, United StatesTaking people
Saint Catherine HospitalIndianapolis, United StatesTaking people
University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesTaking people
City of Hope at Irvine LennarIrvine, United StatesNo longer taking part
Swedish Cancer Institute-IssaquahIssaquah, United StatesTaking people
McFarland Clinic - JeffersonJefferson, United StatesNo longer taking part
Emory Johns Creek HospitalJohns Creek, United StatesTaking people
University of Wisconsin Carbone Cancer Center - Johnson CreekJohnson Creek, United StatesTaking people
Logan Health Medical CenterKalispell, United StatesTaking people
Kansas City Veterans Affairs Medical CenterKansas City, United StatesTaking people
University Health Truman Medical CenterKansas City, United StatesTaking people
University of Kansas Cancer CenterKansas City, United StatesTaking people
University of Kansas Cancer Center - BriarcliffKansas City, United StatesTaking people
University of Kansas Cancer Center - NorthKansas City, United StatesTaking people
Fred and Pamela Buffett Cancer Center - KearneyKearney, United StatesTaking people
Illinois CancerCare-Kewanee ClinicKewanee, United StatesTaking people
Gundersen Lutheran Medical CenterLa Crosse, United StatesTaking people
University of Michigan Health - Sparrow LansingLansing, United StatesTaking people
McLaren Cancer Institute-Lapeer RegionLapeer, United StatesTaking people
Lawrence Memorial HospitalLawrence, United StatesTaking people
Cancer Centers of Southwest Oklahoma ResearchLawton, United StatesTaking people
Veteran Administration Eastern Kansas HealthcareLeavenworth, United StatesNo longer taking part
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
University of Kansas Cancer Center - Lee's SummitLee's Summit, United StatesTaking people
University of Arkansas for Medical SciencesLittle Rock, United StatesTaking people
Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United StatesTaking people
Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
The James Graham Brown Cancer Center at University of LouisvilleLouisville, United StatesTaking people
UofL Health Medical Center NortheastLouisville, United StatesTaking people
Henry Ford Saint John Hospital - Macomb MedicalMacomb, United StatesTaking people
Illinois CancerCare-MacombMacomb, United StatesTaking people
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadison, United StatesTaking people
University of Wisconsin Carbone Cancer Center - University HospitalMadison, United StatesTaking people
Saint John's Hospital - HealtheastMaplewood, United StatesTaking people
McFarland Clinic - MarshalltownMarshalltown, United StatesTaking people
Marshfield Medical Center-MarshfieldMarshfield, United StatesTaking people
Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
Saint Luke's Cancer Institute - MeridianMeridian, United StatesTaking people
Medical College of WisconsinMilwaukee, United StatesTaking people
NYU Langone Hospital - Long IslandMineola, United StatesTaking people
Abbott-Northwestern HospitalMinneapolis, United StatesTaking people
Hennepin County Medical CenterMinneapolis, United StatesTaking people
Marshfield Medical Center - MinocquaMinocqua, United StatesTaking people
Community Medical CenterMissoula, United StatesTaking people
McLaren Cancer Institute-Central MichiganMount Pleasant, United StatesTaking people
SSM Health Good SamaritanMount Vernon, United StatesTaking people
ProHealth D N Greenwald CenterMukwonago, United StatesTaking people
The Community HospitalMunster, United StatesTaking people
Women's Diagnostic Center - MunsterMunster, United StatesTaking people
Saint Alphonsus Cancer Care Center-NampaNampa, United StatesTaking people
Saint Luke's Cancer Institute - NampaNampa, United StatesTaking people
Froedtert and MCW Moorland Reserve Health CenterNew Berlin, United StatesTaking people
Yale UniversityNew Haven, United StatesTaking people
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, United StatesTaking people
NYP/Weill Cornell Medical CenterNew York, United StatesTaking people
Helen F Graham Cancer CenterNewark, United StatesTaking people
Medical Oncology Hematology Consultants PANewark, United StatesTaking people
Providence Newberg Medical CenterNewberg, United StatesTaking people
Yale-New Haven Hospital North Haven Medical CenterNorth Haven, United StatesTaking people
University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas City, United StatesNo longer taking part
Cancer Care Center of O'FallonO'Fallon, United StatesTaking people
ProHealth Oconomowoc Memorial HospitalOconomowoc, United StatesTaking people
University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
The University of Kansas Cancer Center - OlatheOlathe, United StatesTaking people
Nebraska Medicine-Village PointeOmaha, United StatesTaking people
University of Nebraska Medical CenterOmaha, United StatesTaking people
Saint Alphonsus Cancer Care Center-OntarioOntario, United StatesTaking people
Providence Willamette Falls Medical CenterOregon City, United StatesTaking people
Illinois CancerCare-Ottawa ClinicOttawa, United StatesTaking people
University of Kansas Cancer Center-Overland ParkOverland Park, United StatesTaking people
Illinois CancerCare-PekinPekin, United StatesTaking people
Illinois CancerCare-PeoriaPeoria, United StatesTaking people
Illinois CancerCare-PeruPeru, United StatesTaking people
McLaren Cancer Institute-Northern MichiganPetoskey, United StatesTaking people
Freeman Physician Group of PittsburgPittsburg, United StatesTaking people
Trinity Health Saint Joseph Mercy Oakland HospitalPontiac, United StatesTaking people
Providence Portland Medical CenterPortland, United StatesTaking people
Providence Saint Vincent Medical CenterPortland, United StatesTaking people
Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesTaking people
Illinois CancerCare-PrincetonPrinceton, United StatesTaking people
Rhode Island HospitalProvidence, United StatesTaking people
Marshfield Medical Center-Rice LakeRice Lake, United StatesTaking people
VCU Massey Cancer Center at Stony PointRichmond, United StatesTaking people
VCU Massey Comprehensive Cancer CenterRichmond, United StatesTaking people
University of RochesterRochester, United StatesTaking people
Corewell Health William Beaumont University HospitalRoyal Oak, United StatesTaking people
MyMichigan Medical Center SaginawSaginaw, United StatesTaking people
Oncology Hematology Associates of Saginaw Valley PCSaginaw, United StatesNo longer taking part
Coborn Cancer Center at Saint Cloud HospitalSaint Cloud, United StatesTaking people
Dartmouth Cancer Center - NorthSaint Johnsbury, United StatesTaking people
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesTaking people
Regions HospitalSaint Paul, United StatesTaking people
United HospitalSaint Paul, United StatesTaking people
Salina Regional Health CenterSalina, United StatesTaking people
Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesTaking people
Essentia Health SandstoneSandstone, United StatesTaking people
Swedish Medical Center-First HillSeattle, United StatesTaking people
Prisma Health Cancer Institute - SenecaSeneca, United StatesTaking people
Memorial Hospital EastShiloh, United StatesTaking people
Sanford Cancer Center Oncology ClinicSioux Falls, United StatesTaking people
Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesTaking people
CoxHealth South HospitalSpringfield, United StatesTaking people
Mercy Hospital SpringfieldSpringfield, United StatesTaking people
Southern Illinois University School of MedicineSpringfield, United StatesTaking people
Springfield ClinicSpringfield, United StatesTaking people
Springfield Memorial HospitalSpringfield, United StatesTaking people
Mercy Hospital SouthSt Louis, United StatesTaking people
Siteman Cancer Center at Christian HospitalSt Louis, United StatesTaking people
Siteman Cancer Center-South CountySt Louis, United StatesTaking people
Washington University School of MedicineSt Louis, United StatesTaking people
Smilow Cancer Hospital Care Center at Long RidgeStamford, United StatesTaking people
Marshfield Medical Center-River Region at Stevens PointStevens Point, United StatesTaking people
MyMichigan Medical Center TawasTawas City, United StatesTaking people
University of Kansas Health System Saint Francis CampusTopeka, United StatesTaking people
Smilow Cancer Hospital-Torrington Care CenterTorrington, United StatesTaking people
Corewell Health Beaumont Troy HospitalTroy, United StatesTaking people
Smilow Cancer Hospital Care Center-TrumbullTrumbull, United StatesTaking people
Oklahoma Cancer Specialists and Research Institute-TulsaTulsa, United StatesTaking people
Carle Cancer CenterUrbana, United StatesTaking people
Northwest Cancer Center - ValparaisoValparaiso, United StatesTaking people
Essentia Health Virginia ClinicVirginia, United StatesTaking people
Illinois CancerCare - WashingtonWashington, United StatesTaking people
Smilow Cancer Hospital-Waterbury Care CenterWaterbury, United StatesTaking people
Smilow Cancer Hospital Care Center - WaterfordWaterford, United StatesTaking people
UI Health Care Mission Cancer and Blood - Waukee ClinicWaukee, United StatesTaking people
UW Cancer Center at ProHealth CareWaukesha, United StatesTaking people
Wilmot Cancer Institute at WebsterWebster, United StatesTaking people
Saint Mary's Oncology/Hematology Associates of West BranchWest Branch, United StatesNo longer taking part
Smilow Cancer Hospital Care Center - WesterlyWesterly, United StatesTaking people
Marshfield Medical Center - WestonWeston, United StatesTaking people
University of Kansas Hospital-Westwood Cancer CenterWestwood, United StatesTaking people
Minnesota Oncology Hematology PA-WoodburyWoodbury, United StatesTaking people
Huron Gastroenterology PCYpsilanti, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, United StatesTaking people

Questions to ask the study team

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Are travel costs paid?
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Trial details

Who runs it: Alliance for Clinical Trials in Oncology
Trial code: NCT05976763
Record updated: 3 November 2026
Original description: This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.Read full original descriptionShow less
A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy With Zanubrutinib as Upfront Treatment in Older Patients With Mantle Cell Lymphoma
This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.
Inclusion: • Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or evidence of CCND1 rearrangement or t(11;14)(q13;q32) as confirmed by the enrolling center (such as by fluorescence in situ hybridization [FISH], polymerase chain reaction [PCR]/sequencing, karyotype). Patients with cyclin D1 and/or t(11;14) negative mantle cell lymphoma with an expression profile suggesting a diagnosis of mantle cell lymphoma [MCL] such as SOX11 expression are also eligible; Any stage allowed (stage I-IV); Patient must have at least one objective measurable disease parameter by PET or CT. Measurable disease in the liver is required if the liver is the only site of lymphoma OR bone marrow involvement by MCL; Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days prior to registration; No prior systemic treatment for mantle cell lymphoma; No prior radiation treatment for stage I MCL; No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody; No prior stem cell transplant; Age >= 70 years OR age >= 60 to < 70 years with comorbidities precluding autologous stem cell transplantation (autoSCT) including at least one of the following: a) cardiac ejection fraction (EF) <= 45%, b) diffusing capacity for carbon monoxide <= 60% predicted; c) creatinine clearance < 70 but >= 30ml/minute (min); d) Eastern Cooperative Oncology Group (ECOG) performance status of 2, which poses an unacceptable risk of toxicity for high-dose therapy and stem cell transplantation; or e) Cumulative Illness Rating Scales (CIRS) total score > 6; ECOG Performance Status 0-2; Absolute neutrophil count (ANC) >= 750/mm\^3 (without growth factor support within 7 days); Platelet count >= 75,000/mm\^3 (or >= 50,000/mm\^3 if thrombocytopenia is due to lymphoma) without growth factor support or transfusion within 7 days; Creatinine clearance >= 30 mL/ min determined by either: a) Estimation using the Cockcroft-Gault equation or b) Measurement by nuclear medicine scan or 24 hour urine collection; Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome); Aspartate transferase (AST) / alanine transaminase (ALT) =< 3 x ULN; Patients should not be considered candidates for stem cell transplant or must have declined a stem cell transplant strategy; No clinically significant cardiovascular disease including the following; Unstable angina within 3 months before registration; New York Heart Association class III or IV congestive heart failure; History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes); Known QT correction formula (QTcF) > 480 msecs based on Fredericia's formula (unless pacemaker in place); History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place; Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; No active Hepatitis B or Hepatitis C infection. Patients with prior hepatitis B virus (HBV) exposure (positive HBV core antibody and/or surface antigen) are eligible if they have no detectable viral load, and are taking appropriate prophylactic antiviral therapy to prevent reactivation. Patients with history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load; Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial; No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention; No history of stroke or intracranial hemorrhage within 6 months prior to registration; No disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. Patient must be able to swallow pills; Potential trial participants should have recovered from major surgery; No vaccination with a live vaccine within 35 days prior to registration; No hypersensitivity to zanubrutinib or rituximab or any of the other ingredients of the study drugs; Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study; Patients on strong CYP3A4 inducers must discontinue the drug 14 days prior to registration.
ClinicalTrials.gov NCT05976763