Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
NCT ID: NCT05976763
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
421 participants
INTERVENTIONAL
2023-10-20
2038-08-31
Brief Summary
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Detailed Description
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I. To compare time to first progression or death (progression free survival \[PFS\]1) with continuous treatment (Arm A) and time to second progression or death (PFS2) with intermittent treatment that is restarted at first progression (Arm B).
KEY SECONDARY OBJECTIVE:
I. To compare overall survival between patients who achieve a complete remission (CR) with induction therapy subsequently treated with continuous treatment versus (vs.) intermittent treatment as part of maintenance therapy.
SECONDARY OBJECTIVES:
I. To determine overall response rate (ORR) and CR rate to induction therapy with zanubrutinib and rituximab in previously untreated MCL.
II. To determine adverse events during induction and post-induction in each study arm (Arm A and B) by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
III. To determine PFS1, event free survival (EFS) and overall survival (OS) in each study arm (A and B).
IV. To determine the overall response rate (ORR) and complete response rate (CR) after restarting zanubrutinib, following the first progression, in the intermittent treatment arm (Arm B).
V. To compare burden of symptomatic adverse events (AEs) as assessed by Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) between patients randomized to Arm A versus Arm B.
QUALITY OF LIFE PRIMARY OBJECTIVE:
I. To compare health-related quality of life (QOL) at 12 cycles post-randomization as assessed by the Functional Assessment of Cancer Therapy (FACT) Lymphoma Symptom Index-18 (FLYMSI-18) total score between patients randomized to Arm A versus Arm B.
QUALITY OF LIFE SECONDARY OBJECTIVES:
I. To compare health-related QOL at other time points as assessed by the FLYMSI-18 total score between patients randomized to Arm A versus Arm B.
II. To compare burden of symptomatic AEs as assessed by PRO-CTCAE between patients randomized to continuous (Arm A) versus intermittent (Arm B) zanubrutinib treatment.
QUALITY OF LIFE EXPLORATORY OBJECTIVES:
I. To compare the geriatric functional and cognitive PRO as assessed by Elderly Functional Index (EFLI) and Neurology (Neuro) QOL in Arm A versus Arm B.
II. To compare cognitive function at various time points as assessed by the Neuro-QOL between patients randomized to continuous (Arm A) versus intermittent (Arm B) zanubrutinib treatment.
EXPLORATORY OBJECTIVES:
I. To evaluate the completion rate of a lymphoma-specific patient assessment of life survey (PALS) with patient directed questions on life, health, and social determinants of health (SDH) and assess the impact of the survey collected data on outcomes for all enrolled patients (study arms A and B).
II. To evaluate minimal residual disease (MRD) in those patients who achieve a CR after induction therapy (arms A and B) and how detectable MRD status changes after continued therapy vs. discontinuation of therapy (i.e. arms A vs. B).
OUTLINE:
INDUCTION THERAPY: Patients receive zanubrutinib orally (PO) and rituximab intravenously (IV) on study. Patients undergo bone marrow biopsy and fluciclovine F18 (FDG) positron emission tomography (PET)/ computed tomography (CT) or CT throughout the trial. Patients may also undergo esophagogastroduodenoscopy (EGD) and/or colonoscopy on study as clinically indicated. Patients may optionally undergo blood sample collection throughout the trial.
MAINTENANCE THERAPY: Patients achieving a CR after induction therapy are randomized to 1 of 2 arms.
ARM A: Patients receive zanubrutinib PO until first disease progression on study. Patients undergo CT or magnetic resonance imaging (MRI) or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial.
ARM B: Patients undergo observation until first disease progression and then receive zanubrutinib PO until second disease progression on study. Patients undergo CT or MRI or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial.
After completion of study treatment, patients are followed within 30 days and every 6 months for 10 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Induction therapy (Zanubrutinib, rituximab)
Patients receive zanubrutinib PO and rituximab IV on study. Patients undergo bone marrow biopsy and FDG PET/CT or CT throughout the trial. Patients may also undergo EDG and/or colonoscopy on study as clinically indicated. Patients may optionally undergo blood sample collection throughout the trial.
Zanubrutinib
Given PO
Rituximab
Given IV
Patient Observation
Undergo observation
Bone Marrow Biopsy
undergo bone marrow biopsy
Fludeoxyglucose F-18
Given IV
Positron Emission Tomography
Undergo PET
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Esophagogastroduodenoscopy
Undergo EGD
Colonoscopy
Undergo colonoscopy
Biospecimen Collection
Undergo blood sample collection
Questionnaire Administration
Ancillary studies
Arm A (Zanubrutinib)
Patients receive zanubrutinib PO until first disease progression on study. Patients undergo CT or MRI or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial.
Zanubrutinib
Given PO
Patient Observation
Undergo observation
Bone Marrow Biopsy
undergo bone marrow biopsy
Fludeoxyglucose F-18
Given IV
Positron Emission Tomography
Undergo PET
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Esophagogastroduodenoscopy
Undergo EGD
Colonoscopy
Undergo colonoscopy
Biospecimen Collection
Undergo blood sample collection
Questionnaire Administration
Ancillary studies
ARM B (Observation)
Patients undergo observation until first disease progression and then receive zanubrutinib PO until second disease progression on study. Patients undergo CT or MRI or FDG PET/CT throughout the trial. Patients may optionally undergo blood sample collection throughout the trial.
Zanubrutinib
Given PO
Patient Observation
Undergo observation
Bone Marrow Biopsy
undergo bone marrow biopsy
Fludeoxyglucose F-18
Given IV
Positron Emission Tomography
Undergo PET
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Esophagogastroduodenoscopy
Undergo EGD
Colonoscopy
Undergo colonoscopy
Biospecimen Collection
Undergo blood sample collection
Questionnaire Administration
Ancillary studies
Interventions
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Zanubrutinib
Given PO
Rituximab
Given IV
Patient Observation
Undergo observation
Bone Marrow Biopsy
undergo bone marrow biopsy
Fludeoxyglucose F-18
Given IV
Positron Emission Tomography
Undergo PET
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Esophagogastroduodenoscopy
Undergo EGD
Colonoscopy
Undergo colonoscopy
Biospecimen Collection
Undergo blood sample collection
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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Alliance for Clinical Trials in Oncology
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
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Locations
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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
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
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
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 - Main Campus
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
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
Alliance for Clinical Trials in Oncology
Boston, Massachusetts, 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
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
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
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
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2023-03577
Identifier Type: OTHER
Identifier Source: secondary_id
A052101
Identifier Type: -
Identifier Source: org_study_id
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