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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

421 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2038-08-31

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

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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Mantle Cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Zanubrutinib

Intervention Type DRUG

Given PO

Rituximab

Intervention Type BIOLOGICAL

Given IV

Patient Observation

Intervention Type OTHER

Undergo observation

Bone Marrow Biopsy

Intervention Type PROCEDURE

undergo bone marrow biopsy

Fludeoxyglucose F-18

Intervention Type OTHER

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Esophagogastroduodenoscopy

Intervention Type PROCEDURE

Undergo EGD

Colonoscopy

Intervention Type PROCEDURE

Undergo colonoscopy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Questionnaire Administration

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Zanubrutinib

Intervention Type DRUG

Given PO

Patient Observation

Intervention Type OTHER

Undergo observation

Bone Marrow Biopsy

Intervention Type PROCEDURE

undergo bone marrow biopsy

Fludeoxyglucose F-18

Intervention Type OTHER

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Esophagogastroduodenoscopy

Intervention Type PROCEDURE

Undergo EGD

Colonoscopy

Intervention Type PROCEDURE

Undergo colonoscopy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Questionnaire Administration

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Zanubrutinib

Intervention Type DRUG

Given PO

Patient Observation

Intervention Type OTHER

Undergo observation

Bone Marrow Biopsy

Intervention Type PROCEDURE

undergo bone marrow biopsy

Fludeoxyglucose F-18

Intervention Type OTHER

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Esophagogastroduodenoscopy

Intervention Type PROCEDURE

Undergo EGD

Colonoscopy

Intervention Type PROCEDURE

Undergo colonoscopy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Zanubrutinib

Given PO

Intervention Type DRUG

Rituximab

Given IV

Intervention Type BIOLOGICAL

Patient Observation

Undergo observation

Intervention Type OTHER

Bone Marrow Biopsy

undergo bone marrow biopsy

Intervention Type PROCEDURE

Fludeoxyglucose F-18

Given IV

Intervention Type OTHER

Positron Emission Tomography

Undergo PET

Intervention Type PROCEDURE

Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Esophagogastroduodenoscopy

Undergo EGD

Intervention Type PROCEDURE

Colonoscopy

Undergo colonoscopy

Intervention Type PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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PET CAT Scan CT Scan MRI EGD

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status RECRUITING

Tower Cancer Research Foundation

Beverly Hills, California, United States

Site Status RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status ACTIVE_NOT_RECRUITING

City of Hope at Irvine Lennar

Irvine, California, United States

Site Status ACTIVE_NOT_RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States

Site Status RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status RECRUITING

Grady Health System

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

Augusta University Medical Center

Augusta, Georgia, United States

Site Status RECRUITING

Emory Johns Creek Hospital

Johns Creek, Georgia, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Site Status RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

Carle at The Riverfront

Danville, Illinois, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status RECRUITING

Memorial Hospital East

Shiloh, Illinois, United States

Site Status RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Clinic

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, United States

Site Status RECRUITING

Carle Cancer Center

Urbana, Illinois, United States

Site Status RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status RECRUITING

Northwest Cancer Center - Main Campus

Crown Point, Indiana, United States

Site Status RECRUITING

Northwest Oncology LLC

Dyer, Indiana, United States

Site Status RECRUITING

Northwest Cancer Center - Hobart

Hobart, Indiana, United States

Site Status RECRUITING

Saint Mary Medical Center

Hobart, Indiana, United States

Site Status RECRUITING

Saint Catherine Hospital

Indianapolis, Indiana, United States

Site Status RECRUITING

The Community Hospital

Munster, Indiana, United States

Site Status RECRUITING

Women's Diagnostic Center - Munster

Munster, Indiana, United States

Site Status RECRUITING

Northwest Cancer Center - Valparaiso

Valparaiso, Indiana, United States

Site Status RECRUITING

Mary Greeley Medical Center

Ames, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Boone

Boone, Iowa, United States

Site Status RECRUITING

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Site Status RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Site Status RECRUITING

Broadlawns Medical Center

Des Moines, Iowa, United States

Site Status RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

Site Status RECRUITING

UI Healthcare Mission Cancer and Blood - Fort Dodge

Fort Dodge, Iowa, United States

Site Status RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

Site Status RECRUITING

HaysMed

Hays, Kansas, United States

Site Status RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status RECRUITING

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status RECRUITING

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, United States

Site Status RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Site Status RECRUITING

Freeman Physician Group of Pittsburg

Pittsburg, Kansas, United States

Site Status RECRUITING

Salina Regional Health Center

Salina, Kansas, United States

Site Status RECRUITING

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States

Site Status RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Site Status RECRUITING

Alliance for Clinical Trials in Oncology

Boston, Massachusetts, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Site Status RECRUITING

Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, United States

Site Status RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status RECRUITING

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, United States

Site Status RECRUITING

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Site Status RECRUITING

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status SUSPENDED

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status RECRUITING

Hurley Medical Center

Flint, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status RECRUITING

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Central Michigan

Mount Pleasant, Michigan, United States

Site Status RECRUITING

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Site Status RECRUITING

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Site Status RECRUITING

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Site Status RECRUITING

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status SUSPENDED

MyMichigan Medical Center Tawas

Tawas City, Michigan, United States

Site Status RECRUITING

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Site Status RECRUITING

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Site Status SUSPENDED

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Site Status RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status RECRUITING

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States

Site Status RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Site Status RECRUITING

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status RECRUITING

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Site Status RECRUITING

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

Regions Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

United Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

Essentia Health Sandstone

Sandstone, Minnesota, United States

Site Status RECRUITING

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Saint Luke's Hospital

Chesterfield, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status RECRUITING

University Health Truman Medical Center

Kansas City, Missouri, United States

Site Status RECRUITING

University of Kansas Cancer Center - Briarcliff

Kansas City, Missouri, United States

Site Status RECRUITING

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

Site Status RECRUITING

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

Site Status RECRUITING

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States

Site Status SUSPENDED

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status RECRUITING

CoxHealth South Hospital

Springfield, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital South

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Site Status RECRUITING

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status RECRUITING

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status RECRUITING

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status RECRUITING

Logan Health Medical Center

Kalispell, Montana, United States

Site Status RECRUITING

Community Medical Center

Missoula, Montana, United States

Site Status RECRUITING

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States

Site Status RECRUITING

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Hematology Oncology Associates of CNY at Camillus

Camillus, New York, United States

Site Status RECRUITING

Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse, New York, United States

Site Status RECRUITING

NYU Langone Hospital - Long Island

Mineola, New York, United States

Site Status RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Site Status RECRUITING

NYP/Weill Cornell Medical Center

New York, New York, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Wilmot Cancer Institute at Webster

Webster, New York, United States

Site Status RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status RECRUITING

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, United States

Site Status RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status RECRUITING

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status SUSPENDED

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, United States

Site Status RECRUITING

Providence Newberg Medical Center

Newberg, Oregon, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Site Status RECRUITING

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Site Status RECRUITING

Providence Portland Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center - Westerly

Westerly, Rhode Island, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Site Status RECRUITING

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status RECRUITING

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Site Status RECRUITING

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Site Status RECRUITING

Swedish Medical Center-First Hill

Seattle, Washington, United States

Site Status RECRUITING

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Site Status RECRUITING

University of Wisconsin Carbone Cancer Center - Johnson Creek

Johnson Creek, Wisconsin, United States

Site Status RECRUITING

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status RECRUITING

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

Site Status RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Site Status RECRUITING

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

Site Status RECRUITING

Froedtert and MCW Moorland Reserve Health Center

New Berlin, Wisconsin, United States

Site Status RECRUITING

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Site Status RECRUITING

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anne Beaven, MD

Role: CONTACT

919-966-9268

Destin Carlisle

Role: CONTACT

773-702-8824

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Site Public Contact

Role: primary

501-686-8274

Site Public Contact

Role: primary

Site Public Contact

Role: primary

310-423-8965

Site Public Contact

Role: primary

203-785-5702

Site Public Contact

Role: primary

203-785-5702

Site Public Contact

Role: primary

203-785-5702

Site Public Contact

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203-785-5702

Site Public Contact

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203-785-5702

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203-785-5702

Site Public Contact

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203-785-5702

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203-785-5702

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203-785-5702

Site Public Contact

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203-785-5702

Site Public Contact

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203-785-5702

Site Public Contact

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203-785-5702

Site Public Contact

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203-785-5702

Site Public Contact

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302-623-4450

Site Public Contact

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302-623-4450

Site Public Contact

Role: primary

404-778-1868

Site Public Contact

Role: primary

888-946-7447

Site Public Contact

Role: primary

404-778-1868

Site Public Contact

Role: primary

404-851-7115

Site Public Contact

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706-721-2388

Site Public Contact

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404-778-5714

Site Public Contact

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734-712-3671

Site Public Contact

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208-381-2774

Site Public Contact

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734-712-3671

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406-969-6060

Site Public Contact

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208-381-2774

Site Public Contact

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208-381-2774

Site Public Contact

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406-969-6060

Site Public Contact

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208-381-2774

Site Public Contact

Role: primary

406-969-6060

Site Public Contact

Role: primary

406-969-6060

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

312-355-3046

Site Public Contact

Role: primary

800-446-5532

Site Public Contact

Role: primary

217-876-4762

Site Public Contact

Role: primary

217-876-4762

Site Public Contact

Role: primary

815-285-7800

Site Public Contact

Role: primary

800-446-5532

Site Public Contact

Role: primary

217-876-4762

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

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Role: primary

800-446-5532

Site Public Contact

Role: primary

217-876-4762

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

314-747-9912

Site Public Contact

Role: primary

217-545-7929

Site Public Contact

Role: primary

800-444-7541

Site Public Contact

Role: primary

217-528-7541

Site Public Contact

Role: primary

800-446-5532

Site Public Contact

Role: primary

309-243-3605

Site Public Contact

Role: primary

219-310-2550

Site Public Contact

Role: primary

219-924-8178

Site Public Contact

Role: primary

219-947-1795

Site Public Contact

Role: primary

219-836-6875

Site Public Contact

Role: primary

773-702-9171

Site Public Contact

Role: primary

219-836-3349

Site Public Contact

Role: primary

219-934-8869

Site Public Contact

Role: primary

219-836-6875

Site Public Contact

Role: primary

515-956-4132

Site Public Contact

Role: primary

515-239-4734

Site Public Contact

Role: primary

515-241-3305

Site Public Contact

Role: primary

515-956-4132

Site Public Contact

Role: primary

515-689-7658

Site Public Contact

Role: primary

515-241-3305

Site Public Contact

Role: primary

515-241-6727

Site Public Contact

Role: primary

515-241-3305

Site Public Contact

Role: primary

515-282-2200

Site Public Contact

Role: primary

515-358-6613

Site Public Contact

Role: primary

515-241-3305

Site Public Contact

Role: primary

515-956-4132

Site Public Contact

Role: primary

515-282-2921

Site Public Contact

Role: primary

800-237-1225

Site Public Contact

Role: primary

515-956-4132

Site Public Contact

Role: primary

515-956-4132

Site Public Contact

Role: primary

515-241-3305

Site Public Contact

Role: primary

785-623-5774

Site Public Contact

Role: primary

913-588-3671

Site Public Contact

Role: primary

785-505-2800

Site Public Contact

Role: primary

913-588-1569

Site Public Contact

Role: primary

913-588-3671

Site Public Contact

Role: primary

Site Public Contact

Role: primary

785-452-7038

Site Public Contact

Role: primary

785-295-8000

Site Public Contact

Role: primary

913-588-3671

Anne W. Beaven

Role: primary

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

248-551-7695

Site Public Contact

Role: primary

810-762-8038

Site Public Contact

Role: primary

810-762-8038

Site Public Contact

Role: primary

810-762-8038

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

313-343-3166

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

313-576-9790

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

248-551-7695

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

248-551-7695

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

734-712-7251

Site Public Contact

Role: primary

218-333-5000

Site Public Contact

Role: primary

218-786-3308

Site Public Contact

Role: primary

952-993-1517

Site Public Contact

Role: primary

218-786-3308

Site Public Contact

Role: primary

218-786-3308

Site Public Contact

Role: primary

218-786-3308

Site Public Contact

Role: primary

952-993-1517

Site Public Contact

Role: primary

952-993-1517

Site Public Contact

Role: primary

952-993-1517

Site Public Contact

Role: primary

877-229-4907

Site Public Contact

Role: primary

952-993-1517

Site Public Contact

Role: primary

952-993-1517

Site Public Contact

Role: primary

952-993-1517

Site Public Contact

Role: primary

218-786-3308

Site Public Contact

Role: primary

218-786-3308

Site Public Contact

Role: primary

952-993-1517

Site Public Contact

Role: primary

573-334-2230

Site Public Contact

Role: primary

314-205-6936

Site Public Contact

Role: primary

800-600-3606

Site Public Contact

Role: primary

800-600-3606

Site Public Contact

Role: primary

816-404-4375

Site Public Contact

Role: primary

913-588-3671

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Role: primary

913-588-3671

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Role: primary

913-588-3671

Site Public Contact

Role: primary

417-269-4520

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Role: primary

417-269-4520

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Role: primary

800-600-3606

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Role: primary

314-525-6042

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800-600-3606

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800-600-3606

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406-969-6060

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800-996-2663

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406-969-6060

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406-969-6060

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406-969-6060

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406-969-6060

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402-559-6941

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402-559-5600

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402-559-6941

Site Public Contact

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800-639-6918

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800-767-9355

Site Public Contact

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315-472-7504

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315-472-7504

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212-263-4432

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212-746-1848

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585-275-5830

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Role: primary

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877-668-0683

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Role: primary

888-275-3853

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701-323-5760

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218-786-3308

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701-323-5760

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701-234-6161

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800-293-5066

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877-231-4440

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918-505-3200

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503-215-2614

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406-969-6060

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503-215-2614

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503-215-2614

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503-215-2614

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401-444-1488

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864-522-4317

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864-522-4317

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864-522-4317

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864-522-4317

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864-522-4317

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864-522-4317

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864-522-4317

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605-312-3320

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605-312-3320

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888-424-2100

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800-639-6918

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804-628-6430

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206-215-2343

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206-215-2343

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206-215-2343

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218-786-3308

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800-782-8581

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800-622-8922

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608-775-2385

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800-622-8922

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800-622-8922

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800-782-8581

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414-805-3666

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800-782-8581

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414-805-0505

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262-928-7878

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800-782-8581

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800-782-8581

Site Public Contact

Role: primary

262-928-5539

Site Public Contact

Role: primary

800-782-8581

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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