RECRUITING

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

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Conditions

Mantle Cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy With Zanubrutinib as Upfront Treatment in Older Patients With Mantle Cell Lymphoma

Quick Facts

Study Start:2023-09-08
Study Completion:2038-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05976763

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH) as confirmed by the enrolling center
  2. * Any stage allowed (stage I-IV)
  3. * Presence of measurable disease, defined as \>= 1 nodal lesion that is \> 1.5 cm in longest diameter or \>= 1 extranodal lesion that is \> 1 cm in longest diameter
  4. * Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days
  5. * No prior systemic treatment for mantle cell lymphoma
  6. * No prior radiation treatment for stage I MCL
  7. * No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody
  8. * No prior stem cell transplant
  9. * 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
  10. * ECOG Performance Status 0-2
  11. * Absolute neutrophil count (ANC) \>= 750/mm\^3 (without growth factor support within 7 days)
  12. * Platelet count \>= 75,000/mm\^3 (or \>= 50,000/mm\^3 for patients with bone marrow involvement of lymphoma) without growth factor support or transfusion within 7 days
  13. * 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
  14. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome)
  15. * Aspartate transferase (AST) / alanine transaminase (ALT) =\< 3 x ULN
  16. * Patients should not be considered candidates for stem cell transplant or must have declined a stem cell transplant strategy
  17. * No clinically significant cardiovascular disease including the following
  18. * Unstable angina within 3 months before registration
  19. * New York Heart Association class III or IV congestive heart failure
  20. * History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)
  21. * QT correction formula (QTcF) \> 480 msecs based on Fredericia's formula
  22. * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
  23. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  24. * 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
  25. * 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
  26. * 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
  27. * No history of stroke or intracranial hemorrhage within 6 months prior to registration
  28. * 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
  29. * Potential trial participants should have recovered from major surgery
  30. * No vaccination with a live vaccine within 35 days prior to registration
  31. * No hypersensitivity to zanubrutinib or rituximab or any of the other ingredients of the study drugs
  32. * Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.
  33. * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
  34. * Avoid use of moderate CYP3A4 inhibitors, PGP inhibitors, and moderate CYP3A4 inducers
  35. * Archival tissue must be available for submission in all patients for histopathology review, though participation in correlative substudies is optional
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Anne Beaven, MD
CONTACT
919-966-9268
anne_beaven@med.unc.edu
Destin Carlisle
CONTACT
773-702-8824
dcarlisle@bsd.uchicago.edu

Study Locations (Sites)

City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
City of Hope at Irvine Lennar
Irvine, California, 92618
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
United States
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
United States
Yale University
New Haven, Connecticut, 06520
United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473
United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902
United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790
United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708
United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385
United States
Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States
Augusta University Medical Center
Augusta, Georgia, 30912
United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Canton
Canton, Illinois, 61520
United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
United States
Illinois CancerCare-Peru
Peru, Illinois, 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
United States
Memorial Hospital East
Shiloh, Illinois, 62269
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Memorial Medical Center
Springfield, Illinois, 62781
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Illinois CancerCare - Washington
Washington, Illinois, 61571
United States
Northwest Cancer Center - Main Campus
Crown Point, Indiana, 46307
United States
Northwest Oncology LLC
Dyer, Indiana, 46311
United States
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342
United States
Saint Mary Medical Center
Hobart, Indiana, 46342
United States
Saint Catherine Hospital
Indianapolis, Indiana, 46312
United States
The Community Hospital
Munster, Indiana, 46321
United States
Women's Diagnostic Center - Munster
Munster, Indiana, 46321
United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383
United States
Mary Greeley Medical Center
Ames, Iowa, 50010
United States
McFarland Clinic - Ames
Ames, Iowa, 50010
United States
Mission Cancer and Blood - Ankeny
Ankeny, Iowa, 50023
United States
McFarland Clinic - Boone
Boone, Iowa, 50036
United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
United States
HaysMed
Hays, Kansas, 67601
United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
United States
Olathe Health Cancer Center
Olathe, Kansas, 66061
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
United States
Freeman Physician Group of Pittsburg
Pittsburg, Kansas, 66762
United States
Salina Regional Health Center
Salina, Kansas, 67401
United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, 66606
United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
United States
Alliance for Clinical Trials in Oncology
Boston, Massachusetts, 02115
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
United States
Chelsea Hospital
Chelsea, Michigan, 48118
United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
United States
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336
United States
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503
United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503
United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, 48044
United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085
United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
United States
Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805
United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
United Hospital
Saint Paul, Minnesota, 55102
United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072
United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
United States
University Health Truman Medical Center
Kansas City, Missouri, 64108
United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, 64116
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Siteman Cancer Center-South County
Saint Louis, Missouri, 63129
United States
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri, 63136
United States
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri, 63376
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
CoxHealth South Hospital
Springfield, Missouri, 65807
United States
Community Hospital of Anaconda
Anaconda, Montana, 59711
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901
United States
Community Medical Center
Missoula, Montana, 59804
United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057
United States
University of Rochester
Rochester, New York, 14642
United States
Wilmot Cancer Institute at Webster
Webster, New York, 14580
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146
United States
Providence Newberg Medical Center
Newberg, Oregon, 97132
United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, 02891
United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122
United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
United States
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151
United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
United States

Collaborators and Investigators

Sponsor: Alliance for Clinical Trials in Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-08
Study Completion Date2038-08-31

Study Record Updates

Study Start Date2023-09-08
Study Completion Date2038-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Mantle Cell Lymphoma