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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported