Recruiting
Phase 3

Zanubrutinib

Sponsor:

Alliance for Clinical Trials in Oncology

Code:

NCT05976763

Conditions

Mantle Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Zanubrutinib

Rituximab

Patient Observation

Bone Marrow Biopsy

Fludeoxyglucose F-18

Study Details

Brief summary:

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.

Conditions

Mantle Cell Lymphoma

Study ID

NCT05976763

Start date

Oct 20, 2023

Status verified date

Sep, 2026

Completion date

Aug 31, 2038

Anticipated

Primary completion date

Aug 31, 2038

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or evidence of CCND1 rearrangement or t(11;14)(q13;q32) as confirmed by the enrolling center (such as by fluorescence in situ hybridization \[FISH\], polymerase chain reaction \[PCR\]/sequencing, karyotype). Patients with cyclin D1 and/or t(11;14) negative mantle cell lymphoma with an expression profile suggesting a diagnosis of mantle cell lymphoma \[MCL\] such as SOX11 expression are also eligible

  • Any stage allowed (stage I-IV)

  • Patient must have at least one objective measurable disease parameter by PET or CT. Measurable disease in the liver is required if the liver is the only site of lymphoma OR bone marrow involvement by MCL
  • Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days prior to registration
  • 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 if thrombocytopenia is due to 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)
  • Known QT correction formula (QTcF) > 480 msecs based on Fredericia's formula (unless pacemaker in place)
  • 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
  • Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.
  • Patients on strong CYP3A4 inducers must discontinue the drug 14 days prior to registration.

Study Design

Enrollment

421 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

active comparator: 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.

Interventions

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

Primary outcome measure

  • Progression-free survival (PFS) 1 (Arm A) [ Time Frame: Time from randomization until the earlier of first progression or death from any cause, assessed up to 10 years ]
  • Progression-free survival (PFS) 2 (Arm B) [ Time Frame: Time from randomization until the earlier of second progression or death from any cause, assessed up to 10 years ]

Central Contacts and Locations

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Site Public Contact

501-686-8274

Principal Investigator:

Cesar Gentille

Tower Cancer Research Foundation

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Principal Investigator:

Justin M. Darrah

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Justin M. Darrah

Smilow Cancer Hospital-Derby Care Center

Recruiting

Derby, Connecticut, United States, 06418

Contacts

Principal Investigator:

Shalin Kothari

Smilow Cancer Hospital Care Center-Fairfield

Recruiting

Fairfield, Connecticut, United States, 06824

Contacts

Principal Investigator:

Shalin Kothari

Smilow Cancer Hospital Care Center at Glastonbury

Recruiting

Glastonbury, Connecticut, United States, 06033

Contacts

Principal Investigator:

Shalin Kothari

Smilow Cancer Hospital Care Center at Greenwich

Recruiting

Greenwich, Connecticut, United States, 06830

Contacts

Principal Investigator:

Shalin Kothari

Smilow Cancer Hospital Care Center - Guilford

Recruiting

Guilford, Connecticut, United States, 06437

Contacts

Principal Investigator:

Shalin Kothari

Smilow Cancer Hospital Care Center at Saint Francis

Recruiting

Hartford, Connecticut, United States, 06105

Contacts

Principal Investigator:

Shalin Kothari

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Shalin Kothari

Yale-New Haven Hospital North Haven Medical Center

Recruiting

North Haven, Connecticut, United States, 06473

Contacts

Principal Investigator:

Shalin Kothari

Smilow Cancer Hospital Care Center at Long Ridge

Recruiting

Stamford, Connecticut, United States, 06902

Contacts

Principal Investigator:

Shalin Kothari

Smilow Cancer Hospital-Torrington Care Center

Recruiting

Torrington, Connecticut, United States, 06790

Contacts

Principal Investigator:

Shalin Kothari

Smilow Cancer Hospital Care Center-Trumbull

Recruiting

Trumbull, Connecticut, United States, 06611

Contacts

Principal Investigator:

Shalin Kothari

Smilow Cancer Hospital-Waterbury Care Center

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

Principal Investigator:

Shalin Kothari

Smilow Cancer Hospital Care Center - Waterford

Recruiting

Waterford, Connecticut, United States, 06385

Contacts

Principal Investigator:

Shalin Kothari

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Phoebe Putney Memorial Hospital

Recruiting

Albany, Georgia, United States, 31701

Contacts

Principal Investigator:

Locke J. Bryan

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Jonathon B. Cohen

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Jonathon B. Cohen

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Jonathon B. Cohen

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

Jonathon B. Cohen

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Principal Investigator:

Locke J. Bryan

Emory Johns Creek Hospital

Recruiting

Johns Creek, Georgia, United States, 30097

Contacts

Principal Investigator:

Jonathon B. Cohen

Saint Alphonsus Cancer Care Center-Boise

Recruiting

Boise, Idaho, United States, 83706

Contacts

Principal Investigator:

Christopher M. Reynolds

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

Principal Investigator:

Alison K. Conlin

Saint Alphonsus Cancer Care Center-Caldwell

Recruiting

Caldwell, Idaho, United States, 83605

Contacts

Principal Investigator:

Christopher M. Reynolds

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Principal Investigator:

John M. Schallenkamp

Saint Luke's Cancer Institute - Fruitland

Recruiting

Fruitland, Idaho, United States, 83619

Contacts

Principal Investigator:

Alison K. Conlin

Saint Luke's Cancer Institute - Meridian

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Principal Investigator:

Alison K. Conlin

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Principal Investigator:

Christopher M. Reynolds

Saint Luke's Cancer Institute - Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Principal Investigator:

Alison K. Conlin

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Principal Investigator:

John M. Schallenkamp

Illinois CancerCare-Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Canton

Recruiting

Canton, Illinois, United States, 61520

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Carthage

Recruiting

Carthage, Illinois, United States, 62321

Contacts

Principal Investigator:

Bryan A. Faller

Alliance for Clinical Trials in Oncology

Recruiting

Chicago, Illinois, United States, 60606

Contacts

Anne W. Beaven

beaven@med.unc.edu

Principal Investigator:

Anne W. Beaven

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Carlos Galvez

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Principal Investigator:

Maria T. Grosse-Perdekamp

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Dixon

Recruiting

Dixon, Illinois, United States, 61021

Contacts

Site Public Contact

815-285-7800

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Maria T. Grosse-Perdekamp

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Eureka

Recruiting

Eureka, Illinois, United States, 61530

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Galesburg

Recruiting

Galesburg, Illinois, United States, 61401

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Kewanee Clinic

Recruiting

Kewanee, Illinois, United States, 61443

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Macomb

Recruiting

Macomb, Illinois, United States, 61455

Contacts

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Principal Investigator:

Maria T. Grosse-Perdekamp

SSM Health Good Samaritan

Recruiting

Mount Vernon, Illinois, United States, 62864

Contacts

Principal Investigator:

Jay W. Carlson

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Ottawa Clinic

Recruiting

Ottawa, Illinois, United States, 61350

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peru

Recruiting

Peru, Illinois, United States, 61354

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Princeton

Recruiting

Princeton, Illinois, United States, 61356

Contacts

Principal Investigator:

Bryan A. Faller

Memorial Hospital East

Recruiting

Shiloh, Illinois, United States, 62269

Contacts

Principal Investigator:

Brad S. Kahl

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Bryan A. Faller

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

800-444-7541

Principal Investigator:

Bryan A. Faller

Springfield Memorial Hospital

Recruiting

Springfield, Illinois, United States, 62781

Contacts

Principal Investigator:

Bryan A. Faller

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Maria T. Grosse-Perdekamp

Illinois CancerCare - Washington

Recruiting

Washington, Illinois, United States, 61571

Contacts

Principal Investigator:

Bryan A. Faller

Northwest Cancer Center - Crown Point

Recruiting

Crown Point, Indiana, United States, 46307

Contacts

Principal Investigator:

Maria T. Grosse-Perdekamp

Northwest Oncology LLC

Recruiting

Dyer, Indiana, United States, 46311

Contacts

Site Public Contact

219-924-8178

Principal Investigator:

Maria T. Grosse-Perdekamp

Northwest Cancer Center - Hobart

Recruiting

Hobart, Indiana, United States, 46342

Contacts

Site Public Contact

219-947-1795

Principal Investigator:

Maria T. Grosse-Perdekamp

Saint Mary Medical Center

Recruiting

Hobart, Indiana, United States, 46342

Contacts

Principal Investigator:

Maria T. Grosse-Perdekamp

Saint Catherine Hospital

Recruiting

Indianapolis, Indiana, United States, 46312

Contacts

Principal Investigator:

Maria T. Grosse-Perdekamp

The Community Hospital

Recruiting

Munster, Indiana, United States, 46321

Contacts

Site Public Contact

219-836-3349

Principal Investigator:

Maria T. Grosse-Perdekamp

Women's Diagnostic Center - Munster

Recruiting

Munster, Indiana, United States, 46321

Contacts

Principal Investigator:

Maria T. Grosse-Perdekamp

Northwest Cancer Center - Valparaiso

Recruiting

Valparaiso, Indiana, United States, 46383

Contacts

Principal Investigator:

Maria T. Grosse-Perdekamp

Mary Greeley Medical Center

Recruiting

Ames, Iowa, United States, 50010

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Ames

Recruiting

Ames, Iowa, United States, 50010

Contacts

Principal Investigator:

Joseph J. Merchant

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Recruiting

Ankeny, Iowa, United States, 50023

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Saint Anthony Regional Hospital

Recruiting

Carroll, Iowa, United States, 51401

Contacts

Principal Investigator:

Seema Harichand-Herdt

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

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Iowa Methodist Medical Center

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-6727

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Broadlawns Medical Center

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-282-2200

Principal Investigator:

Seema Harichand-Herdt

Mercy Medical Center - Des Moines

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

UI Health Care Mission Cancer and Blood - Laurel Clinic

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

McFarland Clinic - Trinity Cancer Center

Recruiting

Fort Dodge, Iowa, United States, 50501

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

UI Healthcare Mission Cancer and Blood - Fort Dodge

Recruiting

Fort Dodge, Iowa, United States, 50501

Contacts

Principal Investigator:

Seema Harichand-Herdt

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Eric Mou

McFarland Clinic - Marshalltown

Recruiting

Marshalltown, Iowa, United States, 50158

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

UI Health Care Mission Cancer and Blood - Waukee Clinic

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

HaysMed

Recruiting

Hays, Kansas, United States, 67601

Contacts

Site Public Contact

785-623-5774

Principal Investigator:

Marc S. Hoffmann

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Marc S. Hoffmann

Lawrence Memorial Hospital

Recruiting

Lawrence, Kansas, United States, 66044

Contacts

Principal Investigator:

Marc S. Hoffmann

Veteran Administration Eastern Kansas Healthcare

Recruiting

Leavenworth, Kansas, United States, 66048

Contacts

Principal Investigator:

Suman Kambhampati

The University of Kansas Cancer Center - Olathe

Recruiting

Olathe, Kansas, United States, 66061

Contacts

Principal Investigator:

Marc S. Hoffmann

University of Kansas Cancer Center-Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Principal Investigator:

Marc S. Hoffmann

Freeman Physician Group of Pittsburg

Recruiting

Pittsburg, Kansas, United States, 66762

Contacts

Site Public Contact

BNMathew@freemanhealth.com

Principal Investigator:

Marc S. Hoffmann

Salina Regional Health Center

Recruiting

Salina, Kansas, United States, 67401

Contacts

Principal Investigator:

Marc S. Hoffmann

University of Kansas Health System Saint Francis Campus

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Site Public Contact

785-295-8000

Principal Investigator:

Marc S. Hoffmann

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Principal Investigator:

Marc S. Hoffmann

The James Graham Brown Cancer Center at University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Site Public Contact

502-562-3429

Principal Investigator:

Hassaan Yasin

UofL Health Medical Center Northeast

Recruiting

Louisville, Kentucky, United States, 40245

Contacts

Principal Investigator:

Hassaan Yasin

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Principal Investigator:

Christopher M. Reynolds

McLaren Cancer Institute-Bay City

Recruiting

Bay City, Michigan, United States, 48706

Contacts

Principal Investigator:

Dipenkumar Modi

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health Medical Center - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health Medical Center - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Christopher M. Reynolds

Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Christopher M. Reynolds

McLaren Cancer Institute-Clarkston

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

Principal Investigator:

Dipenkumar Modi

Wayne State University/Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Principal Investigator:

Dipenkumar Modi

Weisberg Cancer Treatment Center

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Principal Investigator:

Dipenkumar Modi

Corewell Health Farmington Hills Hospital

Recruiting

Farmington Hills, Michigan, United States, 48336

Contacts

Site Public Contact

248-551-7695

Principal Investigator:

Andrew A. Muskovitz

Cancer Hematology Centers - Flint

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Christopher M. Reynolds

Genesys Hurley Cancer Institute

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Christopher M. Reynolds

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Christopher M. Reynolds

McLaren Cancer Institute-Flint

Recruiting

Flint, Michigan, United States, 48532

Contacts

Principal Investigator:

Dipenkumar Modi

University of Michigan Health - Sparrow Lansing

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Principal Investigator:

Christopher M. Reynolds

McLaren Cancer Institute-Lapeer Region

Recruiting

Lapeer, Michigan, United States, 48446

Contacts

Principal Investigator:

Dipenkumar Modi

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Principal Investigator:

Christopher M. Reynolds

Henry Ford Saint John Hospital - Macomb Medical

Recruiting

Macomb, Michigan, United States, 48044

Contacts

Principal Investigator:

Christopher M. Reynolds

McLaren Cancer Institute-Central Michigan

Recruiting

Mount Pleasant, Michigan, United States, 48858

Contacts

Principal Investigator:

Dipenkumar Modi

McLaren Cancer Institute-Northern Michigan

Recruiting

Petoskey, Michigan, United States, 49770

Contacts

Principal Investigator:

Dipenkumar Modi

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Principal Investigator:

Christopher M. Reynolds

Corewell Health William Beaumont University Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Site Public Contact

248-551-7695

Principal Investigator:

Andrew A. Muskovitz

MyMichigan Medical Center Saginaw

Recruiting

Saginaw, Michigan, United States, 48601

Contacts

Principal Investigator:

Christopher M. Reynolds

MyMichigan Medical Center Tawas

Recruiting

Tawas City, Michigan, United States, 48764

Contacts

Principal Investigator:

Christopher M. Reynolds

Corewell Health Beaumont Troy Hospital

Recruiting

Troy, Michigan, United States, 48085

Contacts

Site Public Contact

248-551-7695

Principal Investigator:

Andrew A. Muskovitz

Huron Gastroenterology PC

Recruiting

Ypsilanti, Michigan, United States, 48106

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Principal Investigator:

Christopher M. Reynolds

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Principal Investigator:

Daniel Almquist

Essentia Health Saint Joseph's Medical Center

Recruiting

Brainerd, Minnesota, United States, 56401

Contacts

Principal Investigator:

Bret E. Friday

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Principal Investigator:

Yan Ji

Essentia Health - Deer River Clinic

Recruiting

Deer River, Minnesota, United States, 56636

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Cancer Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Hibbing Clinic

Recruiting

Hibbing, Minnesota, United States, 55746

Contacts

Site Public Contact

218-786-3308

Principal Investigator:

Bret E. Friday

Saint John's Hospital - Healtheast

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Principal Investigator:

Yan Ji

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

Yan Ji

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Principal Investigator:

Yan Ji

Coborn Cancer Center at Saint Cloud Hospital

Recruiting

Saint Cloud, Minnesota, United States, 56303

Contacts

Principal Investigator:

Donald J. Jurgens

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Principal Investigator:

Yan Ji

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Principal Investigator:

Yan Ji

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Principal Investigator:

Yan Ji

Essentia Health Sandstone

Recruiting

Sandstone, Minnesota, United States, 55072

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Virginia Clinic

Recruiting

Virginia, Minnesota, United States, 55792

Contacts

Principal Investigator:

Bret E. Friday

Minnesota Oncology Hematology PA-Woodbury

Recruiting

Woodbury, Minnesota, United States, 55125

Contacts

Principal Investigator:

Yan Ji

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Saint Luke's Hospital

Recruiting

Chesterfield, Missouri, United States, 63017

Contacts

Site Public Contact

314-205-6936

Principal Investigator:

Mark J. Fesler

Siteman Cancer Center at Saint Peters Hospital

Recruiting

City of Saint Peters, Missouri, United States, 63376

Contacts

Principal Investigator:

Brad S. Kahl

Siteman Cancer Center at West County Hospital

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Principal Investigator:

Brad S. Kahl

University Health Truman Medical Center

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Site Public Contact

816-404-4375

Principal Investigator:

Marc S. Hoffmann

University of Kansas Cancer Center - Briarcliff

Recruiting

Kansas City, Missouri, United States, 64116

Contacts

Site Public Contact

913-588-3671

Principal Investigator:

Marc S. Hoffmann

Kansas City Veterans Affairs Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

Contacts

Site Public Contact

800-525-1483

Principal Investigator:

Suman Kambhampati

University of Kansas Cancer Center - North

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Principal Investigator:

Marc S. Hoffmann

University of Kansas Cancer Center - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Principal Investigator:

Marc S. Hoffmann

Mercy Hospital Springfield

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

CoxHealth South Hospital

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Brad S. Kahl

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Principal Investigator:

Jay W. Carlson

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Principal Investigator:

Brad S. Kahl

Siteman Cancer Center at Christian Hospital

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Principal Investigator:

Brad S. Kahl

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Principal Investigator:

John M. Schallenkamp

Nebraska Medicine-Bellevue

Recruiting

Bellevue, Nebraska, United States, 68123

Contacts

Principal Investigator:

Julie M. Vose

Fred and Pamela Buffett Cancer Center - Kearney

Recruiting

Kearney, Nebraska, United States, 68845

Contacts

Principal Investigator:

Julie M. Vose

Nebraska Medicine-Village Pointe

Recruiting

Omaha, Nebraska, United States, 68118

Contacts

Site Public Contact

402-559-5600

Principal Investigator:

Julie M. Vose

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Principal Investigator:

Julie M. Vose

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Charles Gaulin

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Principal Investigator:

Chelsea Peterson

Hematology Oncology Associates of CNY at Camillus

Recruiting

Camillus, New York, United States, 13031

Contacts

Site Public Contact

315-472-7504

Principal Investigator:

Steven M. Duffy

Hematology Oncology Associates of Central New York-East Syracuse

Recruiting

East Syracuse, New York, United States, 13057

Contacts

Site Public Contact

315-472-7504

Principal Investigator:

Steven M. Duffy

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Principal Investigator:

Peter Martin

Laura and Isaac Perlmutter Cancer Center at NYU Langone

Recruiting

New York, New York, United States, 10016

Contacts

Site Public Contact

CancerTrials@nyulangone.org

Principal Investigator:

Peter Martin

NYP/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-746-1848

Principal Investigator:

Jia Ruan

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Paul M. Barr

Wilmot Cancer Institute at Webster

Recruiting

Webster, New York, United States, 14580

Contacts

Principal Investigator:

Paul M. Barr

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Anne W. Beaven

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Matthew S. McKinney

Sanford Bismarck Medical Center

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Principal Investigator:

Daniel Almquist

Essentia Health Cancer Center-South University Clinic

Recruiting

Fargo, North Dakota, United States, 58103

Contacts

Principal Investigator:

Bret E. Friday

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

David A. Bond

Cancer Centers of Southwest Oklahoma Research

Recruiting

Lawton, Oklahoma, United States, 73505

Contacts

Site Public Contact

877-231-4440

Principal Investigator:

Taha Al-Juhaishi

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Taha Al-Juhaishi

Oklahoma Cancer Specialists and Research Institute-Tulsa

Recruiting

Tulsa, Oklahoma, United States, 74146

Contacts

Site Public Contact

918-505-3200

Principal Investigator:

Mark B. Jennings

Providence Newberg Medical Center

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Principal Investigator:

Alison K. Conlin

Saint Alphonsus Cancer Care Center-Ontario

Recruiting

Ontario, Oregon, United States, 97914

Contacts

Principal Investigator:

Christopher M. Reynolds

Providence Willamette Falls Medical Center

Recruiting

Oregon City, Oregon, United States, 97045

Contacts

Principal Investigator:

Alison K. Conlin

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator:

Alison K. Conlin

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Principal Investigator:

Alison K. Conlin

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Site Public Contact

401-444-1488

Principal Investigator:

Adam J. Olszewski

Smilow Cancer Hospital Care Center - Westerly

Recruiting

Westerly, Rhode Island, United States, 02891

Contacts

Principal Investigator:

Shalin Kothari

Prisma Health Cancer Institute - Spartanburg

Recruiting

Boiling Springs, South Carolina, United States, 29316

Contacts

Principal Investigator:

Suzanne R. Fanning

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Katherine Antel

Prisma Health Cancer Institute - Easley

Recruiting

Easley, South Carolina, United States, 29640

Contacts

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Butternut

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Faris

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Eastside

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Greer

Recruiting

Greer, South Carolina, United States, 29650

Contacts

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Seneca

Recruiting

Seneca, South Carolina, United States, 29672

Contacts

Principal Investigator:

Suzanne R. Fanning

Sanford Cancer Center Oncology Clinic

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Principal Investigator:

Daniel Almquist

Sanford USD Medical Center - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57117-5134

Contacts

Principal Investigator:

Daniel Almquist

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Principal Investigator:

Harsh Shah

Dartmouth Cancer Center - North

Recruiting

Saint Johnsbury, Vermont, United States, 05819

Contacts

Principal Investigator:

Charles Gaulin

VCU Massey Cancer Center at Stony Point

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Site Public Contact

ctoclinops@vcu.edu

Principal Investigator:

Bruce O. Hough

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Bruce O. Hough

Swedish Cancer Institute-Edmonds

Recruiting

Edmonds, Washington, United States, 98026

Contacts

Principal Investigator:

Alison K. Conlin

Swedish Cancer Institute-Issaquah

Recruiting

Issaquah, Washington, United States, 98029

Contacts

Principal Investigator:

Alison K. Conlin

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Principal Investigator:

Alison K. Conlin

ThedaCare Regional Cancer Center

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

Principal Investigator:

Yazhini Vallatharasu

ThedaCare Regional Medical Center - Appleton

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

Principal Investigator:

Yazhini Vallatharasu

Duluth Clinic Ashland

Recruiting

Ashland, Wisconsin, United States, 54806

Contacts

Principal Investigator:

Bret E. Friday

Marshfield Medical Center-EC Cancer Center

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Principal Investigator:

Seth O. Fagbemi

University of Wisconsin Carbone Cancer Center - Johnson Creek

Recruiting

Johnson Creek, Wisconsin, United States, 53038

Contacts

Principal Investigator:

Priyanka Pophali

Gundersen Lutheran Medical Center

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Principal Investigator:

Michael O. Ojelabi

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Recruiting

Madison, Wisconsin, United States, 53718

Contacts

Principal Investigator:

Priyanka Pophali

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Principal Investigator:

Priyanka Pophali

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Principal Investigator:

Seth O. Fagbemi

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Mehdi Hamadani

Marshfield Medical Center - Minocqua

Recruiting

Minocqua, Wisconsin, United States, 54548

Contacts

Principal Investigator:

Seth O. Fagbemi

Froedtert and MCW Moorland Reserve Health Center

Recruiting

New Berlin, Wisconsin, United States, 53151

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Mehdi Hamadani

Marshfield Medical Center-Rice Lake

Recruiting

Rice Lake, Wisconsin, United States, 54868

Contacts

Principal Investigator:

Seth O. Fagbemi

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Principal Investigator:

Seth O. Fagbemi

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Principal Investigator:

Seth O. Fagbemi

More Information

Sponsor

Alliance for Clinical Trials in Oncology

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology on 2026-09-02.