Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
Sponsor: Alliance for Clinical Trials in Oncology • ClinicalTrials.gov ID: NCT05976763
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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.
Interventions
-
Zanubrutinib
(Drug)
Given PO
-
Rituximab
(Biological)
Given IV
-
Patient Observation
(Other)
Undergo observation
-
Bone Marrow Biopsy
(Procedure)
undergo bone marrow biopsy
-
Fludeoxyglucose F-18
(Other)
Given IV
-
Positron Emission Tomography
(Procedure)
Undergo PET
-
Computed Tomography
(Procedure)
Undergo CT
-
Magnetic Resonance Imaging
(Procedure)
Undergo MRI
-
Esophagogastroduodenoscopy
(Procedure)
Undergo EGD
-
Colonoscopy
(Procedure)
Undergo colonoscopy
-
Biospecimen Collection
(Procedure)
Undergo blood sample collection
-
Questionnaire Administration
(Other)
Ancillary studies
Eligibility criteria
Conditions
Locations
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Tower Cancer Research Foundation — Beverly Hills, California, United States
- City of Hope Comprehensive Cancer Center — Duarte, California, United States
- City of Hope at Irvine Lennar — Irvine, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States
- Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut, United States
- Smilow Cancer Hospital Care Center at Glastonbury — Glastonbury, Connecticut, United States
- Smilow Cancer Hospital Care Center at Greenwich — Greenwich, Connecticut, United States
- Smilow Cancer Hospital Care Center - Guilford — Guilford, Connecticut, United States
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
- Yale University — New Haven, Connecticut, United States
- Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut, United States
- Smilow Cancer Hospital Care Center at Long Ridge — Stamford, Connecticut, United States
- Smilow Cancer Hospital-Torrington Care Center — Torrington, Connecticut, United States
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States
- Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut, United States
- Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States
- Helen F Graham Cancer Center — Newark, Delaware, United States
- Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
- Phoebe Putney Memorial Hospital — Albany, Georgia, United States
- Grady Health System — Atlanta, Georgia, United States
- Emory University Hospital Midtown — Atlanta, Georgia, United States
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
- Augusta University Medical Center — Augusta, Georgia, United States
- Emory Johns Creek Hospital — Johns Creek, Georgia, United States
- Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
- Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States
- Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho, United States
- Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
- Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho, United States
- Saint Luke's Cancer Institute - Meridian — Meridian, Idaho, United States
- Saint Alphonsus Cancer Care Center-Nampa — Nampa, Idaho, United States
- Saint Luke's Cancer Institute - Nampa — Nampa, Idaho, United States
- Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
- Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States
- Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
- Illinois CancerCare-Canton — Canton, Illinois, United States
- Illinois CancerCare-Carthage — Carthage, Illinois, United States
- Alliance for Clinical Trials in Oncology — Chicago, Illinois, United States
- University of Illinois — Chicago, Illinois, United States
- Carle at The Riverfront — Danville, Illinois, United States
- Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
- Decatur Memorial Hospital — Decatur, Illinois, United States
- Illinois CancerCare-Dixon — Dixon, Illinois, United States
- Carle Physician Group-Effingham — Effingham, Illinois, United States
- Crossroads Cancer Center — Effingham, Illinois, United States
- Illinois CancerCare-Eureka — Eureka, Illinois, United States
- Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
- Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States
- Illinois CancerCare-Macomb — Macomb, Illinois, United States
- Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
- SSM Health Good Samaritan — Mount Vernon, Illinois, United States
- Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States
- Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States
- Illinois CancerCare-Pekin — Pekin, Illinois, United States
- Illinois CancerCare-Peoria — Peoria, Illinois, United States
- Illinois CancerCare-Peru — Peru, Illinois, United States
- Illinois CancerCare-Princeton — Princeton, Illinois, United States
- Memorial Hospital East — Shiloh, Illinois, United States
- Southern Illinois University School of Medicine — Springfield, Illinois, United States
- Springfield Clinic — Springfield, Illinois, United States
- Springfield Memorial Hospital — Springfield, Illinois, United States
- Carle Cancer Center — Urbana, Illinois, United States
- Illinois CancerCare - Washington — Washington, Illinois, United States
- Northwest Cancer Center - Crown Point — Crown Point, Indiana, United States
- Northwest Oncology LLC — Dyer, Indiana, United States
- Northwest Cancer Center - Hobart — Hobart, Indiana, United States
- Saint Mary Medical Center — Hobart, Indiana, United States
- Saint Catherine Hospital — Indianapolis, Indiana, United States
- The Community Hospital — Munster, Indiana, United States
- Women's Diagnostic Center - Munster — Munster, Indiana, United States
- Northwest Cancer Center - Valparaiso — Valparaiso, Indiana, United States
- Mary Greeley Medical Center — Ames, Iowa, United States
- McFarland Clinic - Ames — Ames, Iowa, United States
- UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
- McFarland Clinic - Boone — Boone, Iowa, United States
- Saint Anthony Regional Hospital — Carroll, Iowa, United States
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
- Iowa Methodist Medical Center — Des Moines, Iowa, United States
- UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
- Broadlawns Medical Center — Des Moines, Iowa, United States
- Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
- UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
- McFarland Clinic - Trinity Cancer Center — Fort Dodge, Iowa, United States
- UI Healthcare Mission Cancer and Blood - Fort Dodge — Fort Dodge, Iowa, United States
- University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
- McFarland Clinic - Jefferson — Jefferson, Iowa, United States
- McFarland Clinic - Marshalltown — Marshalltown, Iowa, United States
- UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States
- HaysMed — Hays, Kansas, United States
- University of Kansas Cancer Center — Kansas City, Kansas, United States
- Lawrence Memorial Hospital — Lawrence, Kansas, United States
- Veteran Administration Eastern Kansas Healthcare — Leavenworth, Kansas, United States
- The University of Kansas Cancer Center - Olathe — Olathe, Kansas, United States
- University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States
- Freeman Physician Group of Pittsburg — Pittsburg, Kansas, United States
- Salina Regional Health Center — Salina, Kansas, United States
- University of Kansas Health System Saint Francis Campus — Topeka, Kansas, United States
- University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
- The James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky, United States
- UofL Health Medical Center Northeast — Louisville, Kentucky, United States
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor — Ann Arbor, Michigan, United States
- McLaren Cancer Institute-Bay City — Bay City, Michigan, United States
- Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton, Michigan, United States
- Trinity Health Medical Center - Brighton — Brighton, Michigan, United States
- Trinity Health IHA Medical Group Hematology Oncology - Canton — Canton, Michigan, United States
- Trinity Health Medical Center - Canton — Canton, Michigan, United States
- Chelsea Hospital — Chelsea, Michigan, United States
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital — Chelsea, Michigan, United States
- McLaren Cancer Institute-Clarkston — Clarkston, Michigan, United States
- Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
- Weisberg Cancer Treatment Center — Farmington Hills, Michigan, United States
- Corewell Health Farmington Hills Hospital — Farmington Hills, Michigan, United States
- Cancer Hematology Centers - Flint — Flint, Michigan, United States
- Genesee Hematology Oncology PC — Flint, Michigan, United States
- Genesys Hurley Cancer Institute — Flint, Michigan, United States
- Hurley Medical Center — Flint, Michigan, United States
- McLaren Cancer Institute-Flint — Flint, Michigan, United States
- University of Michigan Health - Sparrow Lansing — Lansing, Michigan, United States
- McLaren Cancer Institute-Lapeer Region — Lapeer, Michigan, United States
- Trinity Health Saint Mary Mercy Livonia Hospital — Livonia, Michigan, United States
- Henry Ford Saint John Hospital - Macomb Medical — Macomb, Michigan, United States
- McLaren Cancer Institute-Central Michigan — Mount Pleasant, Michigan, United States
- McLaren Cancer Institute-Northern Michigan — Petoskey, Michigan, United States
- Trinity Health Saint Joseph Mercy Oakland Hospital — Pontiac, Michigan, United States
- Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States
- MyMichigan Medical Center Saginaw — Saginaw, Michigan, United States
- Oncology Hematology Associates of Saginaw Valley PC — Saginaw, Michigan, United States
- MyMichigan Medical Center Tawas — Tawas City, Michigan, United States
- Corewell Health Beaumont Troy Hospital — Troy, Michigan, United States
- Saint Mary's Oncology/Hematology Associates of West Branch — West Branch, Michigan, United States
- Huron Gastroenterology PC — Ypsilanti, Michigan, United States
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus — Ypsilanti, Michigan, United States
- Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States
- Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States
- Mercy Hospital — Coon Rapids, Minnesota, United States
- Essentia Health - Deer River Clinic — Deer River, Minnesota, United States
- Essentia Health Cancer Center — Duluth, Minnesota, United States
- Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States
- Saint John's Hospital - Healtheast — Maplewood, Minnesota, United States
- Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States
- Hennepin County Medical Center — Minneapolis, Minnesota, United States
- Coborn Cancer Center at Saint Cloud Hospital — Saint Cloud, Minnesota, United States
- Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States
- Regions Hospital — Saint Paul, Minnesota, United States
- United Hospital — Saint Paul, Minnesota, United States
- Essentia Health Sandstone — Sandstone, Minnesota, United States
- Essentia Health Virginia Clinic — Virginia, Minnesota, United States
- Minnesota Oncology Hematology PA-Woodbury — Woodbury, Minnesota, United States
- Saint Francis Medical Center — Cape Girardeau, Missouri, United States
- Saint Luke's Hospital — Chesterfield, Missouri, United States
- Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
- Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
- University Health Truman Medical Center — Kansas City, Missouri, United States
- University of Kansas Cancer Center - Briarcliff — Kansas City, Missouri, United States
- Kansas City Veterans Affairs Medical Center — Kansas City, Missouri, United States
- University of Kansas Cancer Center - North — Kansas City, Missouri, United States
- University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States
- University of Kansas Cancer Center at North Kansas City Hospital — North Kansas City, Missouri, United States
- Mercy Hospital Springfield — Springfield, Missouri, United States
- CoxHealth South Hospital — Springfield, Missouri, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Mercy Hospital South — St Louis, Missouri, United States
- Siteman Cancer Center-South County — St Louis, Missouri, United States
- Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
- Community Hospital of Anaconda — Anaconda, Montana, United States
- Billings Clinic Cancer Center — Billings, Montana, United States
- Bozeman Health Deaconess Hospital — Bozeman, Montana, United States
- Benefis Sletten Cancer Institute — Great Falls, Montana, United States
- Logan Health Medical Center — Kalispell, Montana, United States
- Community Medical Center — Missoula, Montana, United States
- Nebraska Medicine-Bellevue — Bellevue, Nebraska, United States
- Fred and Pamela Buffett Cancer Center - Kearney — Kearney, Nebraska, United States
- Nebraska Medicine-Village Pointe — Omaha, Nebraska, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- Hematology Oncology Associates of CNY at Camillus — Camillus, New York, United States
- Hematology Oncology Associates of Central New York-East Syracuse — East Syracuse, New York, United States
- NYU Langone Hospital - Long Island — Mineola, New York, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
- NYP/Weill Cornell Medical Center — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- Wilmot Cancer Institute at Webster — Webster, New York, United States
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Sanford Bismarck Medical Center — Bismarck, North Dakota, United States
- Essentia Health Cancer Center-South University Clinic — Fargo, North Dakota, United States
- Sanford Broadway Medical Center — Fargo, North Dakota, United States
- Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
- Cancer Centers of Southwest Oklahoma Research — Lawton, Oklahoma, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- Oklahoma Cancer Specialists and Research Institute-Tulsa — Tulsa, Oklahoma, United States
- Providence Newberg Medical Center — Newberg, Oregon, United States
- Saint Alphonsus Cancer Care Center-Ontario — Ontario, Oregon, United States
- Providence Willamette Falls Medical Center — Oregon City, Oregon, United States
- Providence Portland Medical Center — Portland, Oregon, United States
- Providence Saint Vincent Medical Center — Portland, Oregon, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- Smilow Cancer Hospital Care Center - Westerly — Westerly, Rhode Island, United States
- Prisma Health Cancer Institute - Spartanburg — Boiling Springs, South Carolina, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Prisma Health Cancer Institute - Easley — Easley, South Carolina, United States
- Prisma Health Cancer Institute - Butternut — Greenville, South Carolina, United States
- Prisma Health Cancer Institute - Faris — Greenville, South Carolina, United States
- Prisma Health Cancer Institute - Eastside — Greenville, South Carolina, United States
- Prisma Health Cancer Institute - Greer — Greer, South Carolina, United States
- Prisma Health Cancer Institute - Seneca — Seneca, South Carolina, United States
- Sanford Cancer Center Oncology Clinic — Sioux Falls, South Dakota, United States
- Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
- Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
- Dartmouth Cancer Center - North — Saint Johnsbury, Vermont, United States
- VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States
- VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
- Swedish Cancer Institute-Edmonds — Edmonds, Washington, United States
- Swedish Cancer Institute-Issaquah — Issaquah, Washington, United States
- Swedish Medical Center-First Hill — Seattle, Washington, United States
- ThedaCare Regional Cancer Center — Appleton, Wisconsin, United States
- ThedaCare Regional Medical Center - Appleton — Appleton, Wisconsin, United States
- Duluth Clinic Ashland — Ashland, Wisconsin, United States
- Marshfield Medical Center-EC Cancer Center — Eau Claire, Wisconsin, United States
- University of Wisconsin Carbone Cancer Center - Johnson Creek — Johnson Creek, Wisconsin, United States
- Gundersen Lutheran Medical Center — La Crosse, Wisconsin, United States
- University of Wisconsin Carbone Cancer Center - Eastpark Medical Center — Madison, Wisconsin, United States
- University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States
- Marshfield Medical Center-Marshfield — Marshfield, Wisconsin, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Marshfield Medical Center - Minocqua — Minocqua, Wisconsin, United States
- ProHealth D N Greenwald Center — Mukwonago, Wisconsin, United States
- Froedtert and MCW Moorland Reserve Health Center — New Berlin, Wisconsin, United States
- ProHealth Oconomowoc Memorial Hospital — Oconomowoc, Wisconsin, United States
- Marshfield Medical Center-Rice Lake — Rice Lake, Wisconsin, United States
- Marshfield Medical Center-River Region at Stevens Point — Stevens Point, Wisconsin, United States
- UW Cancer Center at ProHealth Care — Waukesha, Wisconsin, United States
- Marshfield Medical Center - Weston — Weston, Wisconsin, United States
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