Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

NCT05633615 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: S2114NCI-2022-07930U10CA180888
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 87

Brief Summary

This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them.

Conditions

Refractory Diffuse Large B-Cell Lymphoma; Transformed Follic Lymph to Diff Large B-Cell Lymphoma; Transformed Marg Zone Lymph to Diff Large B-Cell Lymphoma; Diffuse Large B-Cell Lymphoma; Grade 3b Follicular Lymphoma; Primary Mediastinal (Thymic) Large B-Cell Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Will compare PFS in participants with relapsed/refractory large B-cell lymphoma or follicular lymphoma grade 3B with stable disease (SD) or partial remission (PR) on first imaging response (day +30 positron emission tomography \[PET\]/computed tomography \[CT\] scan) after commercial CD19 chimeric antigen receptor (CAR) T-cell therapy who are randomized to receive each consolidation therapy versus those that receive no consolidation therapy (i.e. control). Specifically, will compare the PFS of 1) mosunetuzumab consolidation to no consolidation, 2) polatuzumab vedotin consolidation to no consolidation, 3) mosunetuzumab + polatuzumab vedotin to no consolidation. Will analyze results by arm rather than assuming no-interactions in some factorial analyses. Will follow multi-step hypothesis testing procedure of Freidlin and Korn to compare the arms within this randomized Phase II study. Each of the primary comparisons has 81% power using a stratified logrank test at one-sided alpha of 0.05.

  From date of randomization to date of first observation of progressive disease or death due to any cause, assessed up to 2 years

Secondary Outcomes (5)

• Overall survival (OS)

  From date of randomization to date of death due to any cause, assessed up to 2 years

• Complete remission (CR) conversion rate

  Up to 1 year after randomization

• Incidence of adverse events

  Up to 2 years

• Association between total metabolic tumor volume (TMTV), standardized uptake value (SUV) max, and sum product (SPD) of diameters

  Up to 2 years

• Conversion of CR

  Up to 2 years

Study Arms (5)

Step I (lymphodepleting chemotherapy)

EXPERIMENTAL

Patients receive lymphodepleting chemotherapy consisting of fludarabine IV and cyclophosphamide IV on study. Patients then receive tisagenlecleucel IV, axicabtagene ciloleucel IV, or lisocabtagene maraleucel IV on study.

Biological: Axicabtagene Ciloleucel; Drug: Cyclophosphamide; Drug: Fludarabine; Biological: Lisocabtagene Maraleucel; Procedure: Positron Emission Tomography; Biological: Tisagenlecleucel

Step II Arm I (mosunetuzumab)

EXPERIMENTAL

Patients receive mosunetuzumab IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Mosunetuzumab; Procedure: Positron Emission Tomography

Step II Arm II (polatuzumab vedotin)

EXPERIMENTAL

Patients receive polatuzumab vedotin IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Polatuzumab Vedotin; Procedure: Positron Emission Tomography

Step II Arm III (polatuzumab vedotin, mosunetuzumab)

EXPERIMENTAL

Patients receive polatuzumab vedotin IV and mosunetuzumab IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Mosunetuzumab; Drug: Polatuzumab Vedotin; Procedure: Positron Emission Tomography

Step II Arm IV (observation)

ACTIVE COMPARATOR

Patients undergo observation on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study. Patients with subsequent progression within 12 months of CAR T-cell therapy may crossover to Arm III.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Patient Observation; Procedure: Positron Emission Tomography

Interventions

Axicabtagene Ciloleucel BIOLOGICAL

Given IV

Also known as: KTE C19, KTE-C19, KTE-C19 CAR, Yescarta

Step I (lymphodepleting chemotherapy)

Biospecimen Collection PROCEDURE

Undergo collection of blood and tissue samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Step II Arm I (mosunetuzumab); Step II Arm II (polatuzumab vedotin); Step II Arm III (polatuzumab vedotin, mosunetuzumab); Step II Arm IV (observation)

Computed Tomography PROCEDURE

Undergo PET-CT or CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Step II Arm I (mosunetuzumab); Step II Arm II (polatuzumab vedotin); Step II Arm III (polatuzumab vedotin, mosunetuzumab); Step II Arm IV (observation)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719

Step I (lymphodepleting chemotherapy)

Fludarabine DRUG

Given IV

Also known as: Fluradosa

Step I (lymphodepleting chemotherapy)

Lisocabtagene Maraleucel BIOLOGICAL

Given IV

Also known as: Anti-CD19-CAR Genetically Engineered Autologous T Lymphocytes JCAR017, Anti-CD19-CAR Genetically Engineered Autologous T-lymphocytes JCAR017, Autologous Anti-CD19-EGFRt-4-1BB-zeta-modified CAR CD8+ and CD4+ T-lymphocytes JCAR017, Breyanzi, JCAR 017, JCAR017

Step I (lymphodepleting chemotherapy)

Mosunetuzumab BIOLOGICAL

Given IV

Also known as: Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody BTCT4465A, BTCT 4465A, BTCT-4465A, BTCT4465A, CD20/CD3 BiMAb BTCT4465A, RG 7828, RG-7828, RG7828, RO7030816

Step II Arm I (mosunetuzumab); Step II Arm III (polatuzumab vedotin, mosunetuzumab)

Patient Observation OTHER

Undergo observation

Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting

Step II Arm IV (observation)

Polatuzumab Vedotin DRUG

Given IV

Also known as: ADC DCDS4501A, Antibody-Drug Conjugate DCDS4501A, DCDS4501A, FCU 2711, polatuzumab vedotin-piiq, Polivy, RG7596, Ro 5541077-000

Step II Arm II (polatuzumab vedotin); Step II Arm III (polatuzumab vedotin, mosunetuzumab)

Positron Emission Tomography PROCEDURE

Undergo PET-CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Step I (lymphodepleting chemotherapy); Step II Arm I (mosunetuzumab); Step II Arm II (polatuzumab vedotin); Step II Arm III (polatuzumab vedotin, mosunetuzumab); Step II Arm IV (observation)

Tisagenlecleucel BIOLOGICAL

Given IV

Also known as: CART-19, CART19, CTL019, CTL019 T-cells, Kymriah, Tisagenlecleucel-T

Step I (lymphodepleting chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• STEP 1: REGISTRATION: Participants must have a histologically confirmed diagnosis of diffuse large B-cell lymphoma or follicular lymphoma grade 3b or primary mediastinal large B-cell lymphoma (PMBCL)
• STEP 1: REGISTRATION: Participants with transformed DLBCL must have transformed DLBCL from follicular or marginal zone lymphoma
• STEP 1: REGISTRATION: Participant must have bi-dimensionally measurable systemic disease (at least one lesion with longest diameter \> 1.5 cm)
• STEP 1: REGISTRATION: Participants with secondary central nervous system (CNS) lymphoma (parenchymal, spinal cord, meningeal, cerebrospinal fluid involvement) must be asymptomatic from their CNS disease
• STEP 1: REGISTRATION: Participants must be registered for step 1 after they have signed institutional consent for CAR T-cell leukapheresis but prior to the start of lymphodepleting (LD) chemotherapy for commercial CAR T-cell product
• STEP 1: REGISTRATION: In the opinion of the enrolling physician, participants must be felt to be a candidate for CAR T-cell therapy with plans to be treated with Food and Drug Administration (FDA) approved commercially available CD19 CAR T-cell construct.
• Participants must qualify for commercially approved CD19 CAR T-cell therapy per FDA package insert.
• If the CAR T-cell product does not meet parameters to be given as an FDA approved product (i.e. does not meet specification criteria mandated by FDA and is infused under an expanded access protocol \[EAP\] or single participant investigational new drug \[IND\]) the participant will be taken off of study and no longer be eligible for step 2 randomization
• STEP 1: REGISTRATION: Participants are permitted to receive or have received 'bridging therapy' after CAR T-cell leukapheresis. However, participants must not receive polatuzumab vedotin, and/or mosunetuzumab as part of bridging therapy.
• Bridging therapy is defined as lymphoma directed therapy administered between leukapheresis and the start of LD chemotherapy. This includes cytotoxic chemotherapy (e.g.: bendamustine and rituximab \[BR\], rituximab, gemcitabine and oxaliplatin \[R-gem/ox\]), radiation, corticosteroids, as well as novel therapies such as BTK inhibitors (e.g.: Ibrutinib), immunomodulators (e.g.: lenalidomide), monoclonal antibodies (e.g.: rituximab, obinutuzumab, tafasitamab) antibody drug conjugates (e.g: loncastuximab), checkpoint inhibitors (e.g.: pembrolizumab, nivolumab), clinical trial treatments, etc.
• If a participant receives polatuzumab vedotin or mosunetuzumab as bridging they will ineligible to continue on step 1 registration portion of the study and be ineligible for step 2 randomization
• STEP 1: REGISTRATION: PET-CT scan must be planned for completion within 60 days prior to the start of LD chemotherapy.
• All pre-CAR T-cell therapy disease must be assessed and documented on the baseline/pre-registration tumor assessment form.
• If receiving bridging therapy, participants must have a PET-CT scan upon completion of all planned bridging therapy. If the PET-CT scan after completion of bridging therapy is consistent with complete remission per Lugano criteria as determined by enrolling physician, that participant will be ineligible for step 2 randomization.
• Participants are permitted to receive corticosteroids after leukapheresis without the need to repeat a PET-CT scan. If steroids are used, they must be planned to stop no later than 3 days before CAR -T cell infusion.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• SWOG Cancer Research Network: lead
• Genentech, Inc.: collaborator

Study Sites (87)

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

RECRUITING

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

RECRUITING

Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, 72703, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Highlands Oncology Group - Rogers

Rogers, Arkansas, 72758, United States

RECRUITING

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

RECRUITING

UC Irvine Health Cancer Center-Newport

Costa Mesa, California, 92627, United States

RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

RECRUITING

UCI Health Laguna Hills

Laguna Hills, California, 92653, United States

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

RECRUITING

UCSF Medical Center-Parnassus

San Francisco, California, 94143, United States

RECRUITING

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

RECRUITING

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States

RECRUITING

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States

RECRUITING

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States

RECRUITING

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301, United States

RECRUITING

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

Loyola University Medical Center

Maywood, Illinois, 60153, United States

SUSPENDED

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

UofL Health Medical Center Northeast

Louisville, Kentucky, 40245, United States

RECRUITING

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

RECRUITING

Bronson Battle Creek

Battle Creek, Michigan, 49017, United States

RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

RECRUITING

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

RECRUITING

Beacon Kalamazoo Cancer Center

Kalamazoo, Michigan, 49009, United States

RECRUITING

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444, United States

RECRUITING

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, 49120, United States

RECRUITING

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444, United States

RECRUITING

Corewell Health Reed City Hospital

Reed City, Michigan, 49677, United States

RECRUITING

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085, United States

RECRUITING

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, 48075, United States

ACTIVE NOT RECRUITING

Munson Medical Center

Traverse City, Michigan, 49684, United States

RECRUITING

University of Michigan Health - West

Wyoming, Michigan, 49519, United States

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

RECRUITING

NYP/Weill Cornell Medical Center

New York, New York, 10065, United States

SUSPENDED

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Wilmot Cancer Institute at Webster

Webster, New York, 14580, United States

RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

RECRUITING

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, 28025, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

SUSPENDED

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

RECRUITING

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

RECRUITING

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Providence Newberg Medical Center

Newberg, Oregon, 97132, United States

RECRUITING

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

RECRUITING

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

RECRUITING

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

RECRUITING

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

RECRUITING

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

RECRUITING

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

RECRUITING

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

RECRUITING

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819, United States

RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States

RECRUITING

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718, United States

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Froedtert and MCW Moorland Reserve Health Center

New Berlin, Wisconsin, 53151, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

axicabtagene ciloleucel; Specimen Handling; Cyclophosphamide; fludarabine; Watchful Waiting; Observation; polatuzumab vedotin; Magnetic Resonance Spectroscopy; tisagenlecleucel; CTL019 chimeric antigen receptor

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Brian T Hess

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Rogers

CONTACT

210-614-8808; erogers@swog.org

Dana Sparks

CONTACT

210-614-8808; dsparks@swog.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: June 12, 2023
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (87)