Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

421

Participants

Timeline

Start Date

October 20, 2023

Primary Completion Date

August 31, 2038

Study Completion Date

August 31, 2038

Conditions
Mantle Cell Lymphoma
Interventions
DRUG

Zanubrutinib

Given PO

BIOLOGICAL

Rituximab

Given IV

OTHER

Patient Observation

Undergo observation

PROCEDURE

Bone Marrow Biopsy

undergo bone marrow biopsy

OTHER

Fludeoxyglucose F-18

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Esophagogastroduodenoscopy

Undergo EGD

PROCEDURE

Colonoscopy

Undergo colonoscopy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Questionnaire Administration

Ancillary studies

Trial Locations (227)

10016

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10065

RECRUITING

NYP/Weill Cornell Medical Center, New York

11501

RECRUITING

NYU Langone Hospital - Long Island, Mineola

13031

RECRUITING

Hematology Oncology Associates of CNY at Camillus, Camillus

13057

RECRUITING

Hematology Oncology Associates of Central New York-East Syracuse, East Syracuse

14263

RECRUITING

Roswell Park Cancer Institute, Buffalo

14580

RECRUITING

Wilmot Cancer Institute at Webster, Webster

14642

RECRUITING

University of Rochester, Rochester

19713

RECRUITING

Helen F Graham Cancer Center, Newark

RECRUITING

Medical Oncology Hematology Consultants PA, Newark

23235

RECRUITING

VCU Massey Cancer Center at Stony Point, Richmond

23298

RECRUITING

VCU Massey Comprehensive Cancer Center, Richmond

27599

RECRUITING

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27710

RECRUITING

Duke University Medical Center, Durham

29316

RECRUITING

Prisma Health Cancer Institute - Spartanburg, Boiling Springs

29425

RECRUITING

Medical University of South Carolina, Charleston

29605

RECRUITING

Prisma Health Cancer Institute - Butternut, Greenville

RECRUITING

Prisma Health Cancer Institute - Faris, Greenville

29615

RECRUITING

Prisma Health Cancer Institute - Eastside, Greenville

29640

RECRUITING

Prisma Health Cancer Institute - Easley, Easley

29650

RECRUITING

Prisma Health Cancer Institute - Greer, Greer

29672

RECRUITING

Prisma Health Cancer Institute - Seneca, Seneca

30097

RECRUITING

Emory Johns Creek Hospital, Johns Creek

30303

RECRUITING

Grady Health System, Atlanta

30308

RECRUITING

Emory University Hospital Midtown, Atlanta

30322

RECRUITING

Emory University Hospital/Winship Cancer Institute, Atlanta

30342

RECRUITING

Emory Saint Joseph's Hospital, Atlanta

30912

RECRUITING

Augusta University Medical Center, Augusta

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

46307

RECRUITING

Northwest Cancer Center - Main Campus, Crown Point

46311

RECRUITING

Northwest Oncology LLC, Dyer

46312

RECRUITING

Saint Catherine Hospital, Indianapolis

46321

RECRUITING

The Community Hospital, Munster

RECRUITING

Women's Diagnostic Center - Munster, Munster

46342

RECRUITING

Northwest Cancer Center - Hobart, Hobart

RECRUITING

Saint Mary Medical Center, Hobart

46383

RECRUITING

Northwest Cancer Center - Valparaiso, Valparaiso

48044

RECRUITING

Henry Ford Saint John Hospital - Macomb Medical, Macomb

48073

RECRUITING

Corewell Health William Beaumont University Hospital, Royal Oak

48085

RECRUITING

Corewell Health Beaumont Troy Hospital, Troy

48106

RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor

RECRUITING

Huron Gastroenterology PC, Ypsilanti

48114

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton

RECRUITING

Trinity Health Medical Center - Brighton, Brighton

48118

RECRUITING

Chelsea Hospital, Chelsea

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea

48154

RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital, Livonia

48188

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton

RECRUITING

Trinity Health Medical Center - Canton, Canton

48197

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti

48201

RECRUITING

Wayne State University/Karmanos Cancer Institute, Detroit

48334

RECRUITING

Weisberg Cancer Treatment Center, Farmington Hills

48336

RECRUITING

Corewell Health Farmington Hills Hospital, Farmington Hills

48341

RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac

48346

RECRUITING

McLaren Cancer Institute-Clarkston, Clarkston

48446

RECRUITING

McLaren Cancer Institute-Lapeer Region, Lapeer

48503

RECRUITING

Cancer Hematology Centers - Flint, Flint

SUSPENDED

Genesee Hematology Oncology PC, Flint

RECRUITING

Genesys Hurley Cancer Institute, Flint

RECRUITING

Hurley Medical Center, Flint

48532

RECRUITING

McLaren Cancer Institute-Flint, Flint

48601

RECRUITING

MyMichigan Medical Center Saginaw, Saginaw

48604

SUSPENDED

Oncology Hematology Associates of Saginaw Valley PC, Saginaw

48661

SUSPENDED

Saint Mary's Oncology/Hematology Associates of West Branch, West Branch

48706

RECRUITING

McLaren Cancer Institute-Bay City, Bay City

48764

RECRUITING

MyMichigan Medical Center Tawas, Tawas City

48858

RECRUITING

McLaren Cancer Institute-Central Michigan, Mount Pleasant

49770

RECRUITING

McLaren Cancer Institute-Northern Michigan, Petoskey

50010

RECRUITING

Mary Greeley Medical Center, Ames

RECRUITING

McFarland Clinic - Ames, Ames

50023

RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny

50036

RECRUITING

McFarland Clinic - Boone, Boone

50129

RECRUITING

McFarland Clinic - Jefferson, Jefferson

50158

RECRUITING

McFarland Clinic - Marshalltown, Marshalltown

50263

RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic, Waukee

50309

RECRUITING

Iowa Methodist Medical Center, Des Moines

RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic, Des Moines

50314

RECRUITING

Broadlawns Medical Center, Des Moines

RECRUITING

Mercy Medical Center - Des Moines, Des Moines

RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines

50325

RECRUITING

UI Health Care Mission Cancer and Blood - West Des Moines Clinic, Clive

50501

RECRUITING

McFarland Clinic - Trinity Cancer Center, Fort Dodge

RECRUITING

UI Healthcare Mission Cancer and Blood - Fort Dodge, Fort Dodge

51401

RECRUITING

Saint Anthony Regional Hospital, Carroll

52242

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53038

RECRUITING

University of Wisconsin Carbone Cancer Center - Johnson Creek, Johnson Creek

53066

RECRUITING

ProHealth Oconomowoc Memorial Hospital, Oconomowoc

53149

RECRUITING

ProHealth D N Greenwald Center, Mukwonago

53151

RECRUITING

Froedtert and MCW Moorland Reserve Health Center, New Berlin

53188

RECRUITING

UW Cancer Center at ProHealth Care, Waukesha

53226

RECRUITING

Medical College of Wisconsin, Milwaukee

53718

RECRUITING

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison

53792

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

54449

RECRUITING

Marshfield Medical Center-Marshfield, Marshfield

54476

RECRUITING

Marshfield Medical Center - Weston, Weston

54482

RECRUITING

Marshfield Medical Center-River Region at Stevens Point, Stevens Point

54548

RECRUITING

Marshfield Medical Center - Minocqua, Minocqua

54601

RECRUITING

Gundersen Lutheran Medical Center, La Crosse

54701

RECRUITING

Marshfield Medical Center-EC Cancer Center, Eau Claire

54806

RECRUITING

Duluth Clinic Ashland, Ashland

54868

RECRUITING

Marshfield Medical Center-Rice Lake, Rice Lake

55072

RECRUITING

Essentia Health Sandstone, Sandstone

55101

RECRUITING

Regions Hospital, Saint Paul

55102

RECRUITING

United Hospital, Saint Paul

55109

RECRUITING

Saint John's Hospital - Healtheast, Maplewood

55125

RECRUITING

Minnesota Oncology Hematology PA-Woodbury, Woodbury

55407

RECRUITING

Abbott-Northwestern Hospital, Minneapolis

55415

RECRUITING

Hennepin County Medical Center, Minneapolis

55416

RECRUITING

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55433

RECRUITING

Mercy Hospital, Coon Rapids

55746

RECRUITING

Essentia Health Hibbing Clinic, Hibbing

55792

RECRUITING

Essentia Health Virginia Clinic, Virginia

55805

RECRUITING

Essentia Health Cancer Center, Duluth

56303

RECRUITING

Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud

56401

RECRUITING

Essentia Health Saint Joseph's Medical Center, Brainerd

56601

RECRUITING

Sanford Joe Lueken Cancer Center, Bemidji

56636

RECRUITING

Essentia Health - Deer River Clinic, Deer River

57104

RECRUITING

Sanford Cancer Center Oncology Clinic, Sioux Falls

58103

RECRUITING

Essentia Health Cancer Center-South University Clinic, Fargo

58122

RECRUITING

Sanford Broadway Medical Center, Fargo

RECRUITING

Sanford Roger Maris Cancer Center, Fargo

58501

RECRUITING

Sanford Bismarck Medical Center, Bismarck

59101

RECRUITING

Billings Clinic Cancer Center, Billings

59405

RECRUITING

Benefis Sletten Cancer Institute, Great Falls

59711

RECRUITING

Community Hospital of Anaconda, Anaconda

59715

RECRUITING

Bozeman Health Deaconess Hospital, Bozeman

59804

RECRUITING

Community Medical Center, Missoula

59901

RECRUITING

Logan Health Medical Center, Kalispell

60612

RECRUITING

University of Illinois, Chicago

61021

RECRUITING

Illinois CancerCare-Dixon, Dixon

61350

RECRUITING

Illinois CancerCare-Ottawa Clinic, Ottawa

61354

RECRUITING

Illinois CancerCare-Peru, Peru

61356

RECRUITING

Illinois CancerCare-Princeton, Princeton

61401

RECRUITING

Illinois CancerCare-Galesburg, Galesburg

61443

RECRUITING

Illinois CancerCare-Kewanee Clinic, Kewanee

61455

RECRUITING

Illinois CancerCare-Macomb, Macomb

61520

RECRUITING

Illinois CancerCare-Canton, Canton

61530

RECRUITING

Illinois CancerCare-Eureka, Eureka

61554

RECRUITING

Illinois CancerCare-Pekin, Pekin

61571

RECRUITING

Illinois CancerCare - Washington, Washington

61615

RECRUITING

Illinois CancerCare-Peoria, Peoria

61704

RECRUITING

Illinois CancerCare-Bloomington, Bloomington

61801

RECRUITING

Carle Cancer Center, Urbana

61832

RECRUITING

Carle at The Riverfront, Danville

61938

RECRUITING

Carle Physician Group-Mattoon/Charleston, Mattoon

62269

RECRUITING

Cancer Care Center of O'Fallon, O'Fallon

RECRUITING

Memorial Hospital East, Shiloh

62321

RECRUITING

Illinois CancerCare-Carthage, Carthage

62401

RECRUITING

Carle Physician Group-Effingham, Effingham

RECRUITING

Crossroads Cancer Center, Effingham

62526

RECRUITING

Cancer Care Specialists of Illinois - Decatur, Decatur

RECRUITING

Decatur Memorial Hospital, Decatur

62702

RECRUITING

Southern Illinois University School of Medicine, Springfield

RECRUITING

Springfield Clinic, Springfield

62781

RECRUITING

Springfield Memorial Hospital, Springfield

63017

RECRUITING

Saint Luke's Hospital, Chesterfield

63110

RECRUITING

Washington University School of Medicine, St Louis

63128

RECRUITING

Mercy Hospital South, St Louis

63129

RECRUITING

Siteman Cancer Center-South County, St Louis

63136

RECRUITING

Siteman Cancer Center at Christian Hospital, St Louis

63141

RECRUITING

Siteman Cancer Center at West County Hospital, Creve Coeur

63376

RECRUITING

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

63703

RECRUITING

Saint Francis Medical Center, Cape Girardeau

64064

RECRUITING

University of Kansas Cancer Center - Lee's Summit, Lee's Summit

64108

RECRUITING

University Health Truman Medical Center, Kansas City

64116

SUSPENDED

University of Kansas Cancer Center at North Kansas City Hospital, North Kansas City

64154

RECRUITING

University of Kansas Cancer Center - North, Kansas City

65804

RECRUITING

Mercy Hospital Springfield, Springfield

65807

RECRUITING

CoxHealth South Hospital, Springfield

66044

RECRUITING

Lawrence Memorial Hospital, Lawrence

66061

RECRUITING

The University of Kansas Cancer Center - Olathe, Olathe

66160

RECRUITING

University of Kansas Cancer Center, Kansas City

66205

RECRUITING

University of Kansas Hospital-Westwood Cancer Center, Westwood

66210

RECRUITING

University of Kansas Cancer Center-Overland Park, Overland Park

66606

RECRUITING

University of Kansas Health System Saint Francis Campus, Topeka

66762

RECRUITING

Freeman Physician Group of Pittsburg, Pittsburg

67401

RECRUITING

Salina Regional Health Center, Salina

67601

RECRUITING

HaysMed, Hays

68118

RECRUITING

Nebraska Medicine-Village Pointe, Omaha

68123

RECRUITING

Nebraska Medicine-Bellevue, Bellevue

68198

RECRUITING

University of Nebraska Medical Center, Omaha

72205

RECRUITING

University of Arkansas for Medical Sciences, Little Rock

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

73505

RECRUITING

Cancer Centers of Southwest Oklahoma Research, Lawton

74146

RECRUITING

Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa

83605

RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell

83619

RECRUITING

Saint Luke's Cancer Institute - Fruitland, Fruitland

83642

RECRUITING

Saint Luke's Cancer Institute - Meridian, Meridian

83687

RECRUITING

Saint Alphonsus Cancer Care Center-Nampa, Nampa

RECRUITING

Saint Luke's Cancer Institute - Nampa, Nampa

83706

RECRUITING

Saint Alphonsus Cancer Care Center-Boise, Boise

83712

RECRUITING

Saint Luke's Cancer Institute - Boise, Boise

83814

RECRUITING

Kootenai Health - Coeur d'Alene, Coeur d'Alene

83854

RECRUITING

Kootenai Clinic Cancer Services - Post Falls, Post Falls

83864

RECRUITING

Kootenai Clinic Cancer Services - Sandpoint, Sandpoint

84112

RECRUITING

Huntsman Cancer Institute/University of Utah, Salt Lake City

90048

RECRUITING

Cedars Sinai Medical Center, Los Angeles

90211

RECRUITING

Tower Cancer Research Foundation, Beverly Hills

91010

RECRUITING

City of Hope Comprehensive Cancer Center, Duarte

92618

RECRUITING

City of Hope at Irvine Lennar, Irvine

97045

RECRUITING

Providence Willamette Falls Medical Center, Oregon City

97132

RECRUITING

Providence Newberg Medical Center, Newberg

97213

RECRUITING

Providence Portland Medical Center, Portland

97225

RECRUITING

Providence Saint Vincent Medical Center, Portland

97914

RECRUITING

Saint Alphonsus Cancer Care Center-Ontario, Ontario

98026

RECRUITING

Swedish Cancer Institute-Edmonds, Edmonds

98029

RECRUITING

Swedish Cancer Institute-Issaquah, Issaquah

98122

RECRUITING

Swedish Medical Center-First Hill, Seattle

06418

RECRUITING

Smilow Cancer Hospital-Derby Care Center, Derby

06824

RECRUITING

Smilow Cancer Hospital Care Center-Fairfield, Fairfield

06033

RECRUITING

Smilow Cancer Hospital Care Center at Glastonbury, Glastonbury

06830

RECRUITING

Smilow Cancer Hospital Care Center at Greenwich, Greenwich

06437

RECRUITING

Smilow Cancer Hospital Care Center - Guilford, Guilford

06105

RECRUITING

Smilow Cancer Hospital Care Center at Saint Francis, Hartford

06520

RECRUITING

Yale University, New Haven

06473

RECRUITING

Yale-New Haven Hospital North Haven Medical Center, North Haven

06902

RECRUITING

Smilow Cancer Hospital Care Center at Long Ridge, Stamford

06790

RECRUITING

Smilow Cancer Hospital-Torrington Care Center, Torrington

06611

RECRUITING

Smilow Cancer Hospital Care Center-Trumbull, Trumbull

06708

RECRUITING

Smilow Cancer Hospital-Waterbury Care Center, Waterbury

06385

RECRUITING

Smilow Cancer Hospital Care Center - Waterford, Waterford

02115

RECRUITING

Alliance for Clinical Trials in Oncology, Boston

03756

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

02903

RECRUITING

Rhode Island Hospital, Providence

02891

RECRUITING

Smilow Cancer Hospital Care Center - Westerly, Westerly

57117-5134

RECRUITING

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05819

RECRUITING

Dartmouth Cancer Center - North, Saint Johnsbury

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Alliance for Clinical Trials in Oncology

OTHER

NCT05976763 - Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma | Biotech Hunter | Biotech Hunter