ClinConnect ClinConnect Logo
Search / Trial NCT05976763

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

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Jul 26, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the best way to use the drug zanubrutinib for older patients with mantle cell lymphoma (MCL) who have not been treated before. Specifically, researchers want to find out if it's better to give zanubrutinib continuously or in intervals after patients have achieved a complete remission (meaning no signs of cancer) with another medication called rituximab. The goal is to see if patients can safely stop taking zanubrutinib and only restart it if their cancer comes back, rather than keeping them on the drug indefinitely, which can have side effects and be costly.

To participate in this trial, you need to be an older adult (at least 60 years old, or 70 years and older) with a confirmed diagnosis of MCL and certain health conditions that make stem cell transplantation not an option for you. Participants can expect to receive careful monitoring and support throughout the study. This trial is important because it seeks to improve treatment approaches for older patients, aiming to reduce the burden of long-term medication use while still effectively managing their cancer.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • 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
  • Any stage allowed (stage I-IV)
  • 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
  • Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days
  • 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 for patients with bone marrow involvement of 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)
  • QT correction formula (QTcF) \> 480 msecs based on Fredericia's formula
  • 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
  • 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.
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
  • Avoid use of moderate CYP3A4 inhibitors, PGP inhibitors, and moderate CYP3A4 inducers
  • Archival tissue must be available for submission in all patients for histopathology review, though participation in correlative substudies is optional

About Alliance For Clinical Trials In Oncology

The Alliance for Clinical Trials in Oncology is a prominent cooperative group dedicated to conducting high-quality, innovative clinical research aimed at improving cancer treatment and patient outcomes. Comprising a diverse network of institutions and investigators, the Alliance focuses on developing and implementing clinical trials that evaluate new therapies, treatment combinations, and prevention strategies across various cancer types. By fostering collaboration among oncologists, researchers, and healthcare professionals, the Alliance aims to accelerate the translation of scientific discoveries into effective clinical practices, ultimately enhancing the standard of care for cancer patients.

Locations

New Haven, Connecticut, United States

Durham, North Carolina, United States

Milwaukee, Wisconsin, United States

Charleston, South Carolina, United States

Buffalo, New York, United States

Saint Louis, Missouri, United States

Flint, Michigan, United States

Providence, Rhode Island, United States

Flint, Michigan, United States

Oklahoma City, Oklahoma, United States

Duarte, California, United States

Des Moines, Iowa, United States

La Crosse, Wisconsin, United States

Saint Paul, Minnesota, United States

Bozeman, Montana, United States

Kalispell, Montana, United States

Salina, Kansas, United States

Coon Rapids, Minnesota, United States

Urbana, Illinois, United States

Carroll, Iowa, United States

Ann Arbor, Michigan, United States

Minneapolis, Minnesota, United States

Saint Paul, Minnesota, United States

Chesterfield, Missouri, United States

Effingham, Illinois, United States

Lawrence, Kansas, United States

Springfield, Illinois, United States

Portland, Oregon, United States

Springfield, Illinois, United States

Troy, Michigan, United States

Minneapolis, Minnesota, United States

Rochester, New York, United States

Salt Lake City, Utah, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Iowa City, Iowa, United States

Detroit, Michigan, United States

Duluth, Minnesota, United States

Omaha, Nebraska, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Bismarck, North Dakota, United States

Fargo, North Dakota, United States

Columbus, Ohio, United States

Tulsa, Oklahoma, United States

Cape Girardeau, Missouri, United States

Saint Louis Park, Minnesota, United States

Beverly Hills, California, United States

Royal Oak, Michigan, United States

Sioux Falls, South Dakota, United States

Richmond, Virginia, United States

Augusta, Georgia, United States

Marshfield, Wisconsin, United States

Portland, Oregon, United States

Decatur, Illinois, United States

Ottawa, Illinois, United States

Peoria, Illinois, United States

Des Moines, Iowa, United States

Brainerd, Minnesota, United States

Los Angeles, California, United States

Maplewood, Minnesota, United States

Great Falls, Montana, United States

Hartford, Connecticut, United States

Atlanta, Georgia, United States

Galesburg, Illinois, United States

Kansas City, Kansas, United States

Topeka, Kansas, United States

Bemidji, Minnesota, United States

Woodbury, Minnesota, United States

Springfield, Missouri, United States

Springfield, Missouri, United States

Billings, Montana, United States

Missoula, Montana, United States

Sioux Falls, South Dakota, United States

Oconomowoc, Wisconsin, United States

Rice Lake, Wisconsin, United States

Weston, Wisconsin, United States

Livonia, Michigan, United States

East Syracuse, New York, United States

Newberg, Oregon, United States

Munster, Indiana, United States

Boise, Idaho, United States

Torrington, Connecticut, United States

Canton, Illinois, United States

Carthage, Illinois, United States

Eureka, Illinois, United States

Kewanee, Illinois, United States

Macomb, Illinois, United States

Peru, Illinois, United States

Princeton, Illinois, United States

Boise, Idaho, United States

Fargo, North Dakota, United States

Greenville, South Carolina, United States

Atlanta, Georgia, United States

Post Falls, Idaho, United States

Bloomington, Illinois, United States

Pekin, Illinois, United States

Saint Louis, Missouri, United States

Lawton, Oklahoma, United States

Boiling Springs, South Carolina, United States

Easley, South Carolina, United States

Greenville, South Carolina, United States

Greenville, South Carolina, United States

Greer, South Carolina, United States

Seneca, South Carolina, United States

Olathe, Kansas, United States

Saint Louis, Missouri, United States

Atlanta, Georgia, United States

Fruitland, Idaho, United States

Meridian, Idaho, United States

Overland Park, Kansas, United States

Farmington Hills, Michigan, United States

Kansas City, Missouri, United States

Lee's Summit, Missouri, United States

Fargo, North Dakota, United States

Oregon City, Oregon, United States

Edmonds, Washington, United States

Issaquah, Washington, United States

Springfield, Illinois, United States

Saint Peters, Missouri, United States

Great Falls, Montana, United States

Newark, Delaware, United States

Newark, Delaware, United States

Caldwell, Idaho, United States

Coeur D'alene, Idaho, United States

Sandpoint, Idaho, United States

Brighton, Michigan, United States

Canton, Michigan, United States

Chelsea, Michigan, United States

Farmington Hills, Michigan, United States

Flint, Michigan, United States

Flint, Michigan, United States

Macomb, Michigan, United States

Saginaw, Michigan, United States

West Branch, Michigan, United States

Ypsilanti, Michigan, United States

Anaconda, Montana, United States

Ontario, Oregon, United States

Decatur, Illinois, United States

Effingham, Illinois, United States

Mattoon, Illinois, United States

O'fallon, Illinois, United States

Brighton, Michigan, United States

Canton, Michigan, United States

Chelsea, Michigan, United States

Ypsilanti, Michigan, United States

Ames, Iowa, United States

Richmond, Virginia, United States

Creve Coeur, Missouri, United States

Saint Louis, Missouri, United States

Eau Claire, Wisconsin, United States

Mukwonago, Wisconsin, United States

Waukesha, Wisconsin, United States

Trumbull, Connecticut, United States

Des Moines, Iowa, United States

Westwood, Kansas, United States

North Kansas City, Missouri, United States

Seattle, Washington, United States

Derby, Connecticut, United States

Fairfield, Connecticut, United States

North Haven, Connecticut, United States

Waterbury, Connecticut, United States

Waterford, Connecticut, United States

Stevens Point, Wisconsin, United States

Boston, Massachusetts, United States

Johns Creek, Georgia, United States

Greenwich, Connecticut, United States

Deer River, Minnesota, United States

Hibbing, Minnesota, United States

Sandstone, Minnesota, United States

Virginia, Minnesota, United States

Ashland, Wisconsin, United States

Fort Dodge, Iowa, United States

Bellevue, Nebraska, United States

Omaha, Nebraska, United States

Dixon, Illinois, United States

Washington, Illinois, United States

Bozeman, Montana, United States

Irvine, California, United States

Stamford, Connecticut, United States

Crown Point, Indiana, United States

Dyer, Indiana, United States

Hobart, Indiana, United States

Hobart, Indiana, United States

Indianapolis, Indiana, United States

Munster, Indiana, United States

Valparaiso, Indiana, United States

Glastonbury, Connecticut, United States

Westerly, Rhode Island, United States

Missoula, Montana, United States

Nampa, Idaho, United States

Springfield, Illinois, United States

New Berlin, Wisconsin, United States

Shiloh, Illinois, United States

Kansas City, Missouri, United States

Kalispell, Montana, United States

Lebanon, New Hampshire, United States

Nampa, Idaho, United States

Pittsburg, Kansas, United States

Ann Arbor, Michigan, United States

Brighton, Michigan, United States

Chelsea, Michigan, United States

Webster, New York, United States

Danville, Illinois, United States

Guilford, Connecticut, United States

Boone, Iowa, United States

Fort Dodge, Iowa, United States

Jefferson, Iowa, United States

Marshalltown, Iowa, United States

Ames, Iowa, United States

Canton, Michigan, United States

Minocqua, Wisconsin, United States

Ankeny, Iowa, United States

Des Moines, Iowa, United States

Hays, Kansas, United States

Madison, Wisconsin, United States

Saint Johnsbury, Vermont, United States

Royal Oak, Michigan, United States

Johnson Creek, Wisconsin, United States

Sandpoint, Idaho, United States

Ontario, Oregon, United States

Farmington Hills, Michigan, United States

Troy, Michigan, United States

Saginaw, Michigan, United States

Tawas City, Michigan, United States

Camillus, New York, United States

Madison, Wisconsin, United States

Flint, Michigan, United States

Macomb, Michigan, United States

Olathe, Kansas, United States

Ankeny, Iowa, United States

Des Moines, Iowa, United States

Macomb Township, Michigan, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported