En klinisk studie av zilovertamab vedotin (MK-2140) pluss rituximab pluss cyklofosfamid, doxorubicin og prednison (R-CHP) versus polatuzumab vedlin) (MK-CHP i personer med diffus B-Cell Lymfom -01) (MK-CHP i person
12. november 2026 oppdatert av: Merck Sharp & Dohme LLC
Fase 2-studie som evaluerte effektiviteten og sikkerheten til Zilovertamab Vedotin (MK-2140) pluss R-CHP versus Polatuzumab Vedotin pluss R-CHP i behandling-naivt deltakere med GCB-subtype av diffus-stor B-cell lymfomfom (DLBCl)
Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing.
The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.
Studieoversikt
Status
Rekruttering
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
594
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studiesteder
-
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Antwerpen
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Mechelen, Antwerpen, Belgia, 2800
- Rekruttering
- AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0306)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3215891669
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Bruxelles-Capitale, Region de
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Brussels, Bruxelles-Capitale, Region de, Belgia, 1200
- Rekruttering
- Cliniques Universitaires Saint-Luc ( Site 0302)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3227641810
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Hainaut
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Haine-Saint-Paul, Hainaut, Belgia, 7100
- Rekruttering
- Hopital de Jolimont ( Site 0304)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3264231726
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Oost-Vlaanderen
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Sint-Niklaas, Oost-Vlaanderen, Belgia, 9100
- Rekruttering
- VITAZ ( Site 0307)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 3237602327
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgia, 3000
- Rekruttering
- UZ Leuven ( Site 0301)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3216340938
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West-Vlaanderen
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Bruges, West-Vlaanderen, Belgia, 8000
- Rekruttering
- AZ Sint Jan Brugge-Oostende ( Site 0308)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +3250452328
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Roeselare, West-Vlaanderen, Belgia, 8800
- Rekruttering
- AZ Delta ( Site 0303)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +32(0)51237447
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Alabama
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Mobile, Alabama, Forente stater, 36607
- Rekruttering
- Infirmary Cancer Care ( Site 0157)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 251-435-2273
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Arizona
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Chandler, Arizona, Forente stater, 85224
- Rekruttering
- Ironwood Cancer & Research Centers ( Site 0204)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 480-314-6670
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Glendale, Arizona, Forente stater, 85304
- Rekruttering
- Palo Verde Cancer Specialists ( Site 0105)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 602-978-6255
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Goodyear, Arizona, Forente stater, 85338
- Rekruttering
- City of Hope - Phoenix ( Site 0202)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 602-883-1537
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Arkansas
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Hot Springs, Arkansas, Forente stater, 71913
- Rekruttering
- Genesis Cancer and Blood Institute ( Site 0193)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 501-624-7700
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California
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Burbank, California, Forente stater, 91505
- Rekruttering
- Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 818-840-0921
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Duarte, California, Forente stater, 91010
- Rekruttering
- City of Hope Comprehensive Cancer Center ( Site 0191)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 626-218-2405
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La Jolla, California, Forente stater, 92093
- Rekruttering
- Moores Cancer Center ( Site 0187)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 858-822-6100
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Walnut Creek, California, Forente stater, 94598
- Rekruttering
- Bass Medical Group ( Site 0123)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 925-433-8786
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Colorado
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Aurora, Colorado, Forente stater, 80012
- Rekruttering
- Rocky Mountain Cancer Centers (RMCC) ( Site 8001)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 303-925-0700
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Grand Junction, Colorado, Forente stater, 81505
- Rekruttering
- Colorado West Healthcare System-Grand Valley Oncology ( Site 0165)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 970-644-4460
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Delaware
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Newark, Delaware, Forente stater, 19713
- Rekruttering
- Medical Oncology Hematology Consultants (MOHC) ( Site 8007)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 302-366-1200
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20007
- Rekruttering
- Georgetown University Medical Center ( Site 0117)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 202-444-2223
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Florida
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Boca Raton, Florida, Forente stater, 33486
- Rekruttering
- Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 561-955-4800
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Jacksonville, Florida, Forente stater, 32207
- Rekruttering
- Baptist MD Anderson Cancer Center ( Site 0176)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 904-202-7300
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Miami Beach, Florida, Forente stater, 33140
- Rekruttering
- Mount Sinai Braman Comprehensive Cancer Center ( Site 0140)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 305-674-2625
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Orange City, Florida, Forente stater, 32763
- Rekruttering
- Mid Florida Hematology and Oncology Center ( Site 0152)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 386-774-1223
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Idaho
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Post Falls, Idaho, Forente stater, 83854
- Rekruttering
- Beacon Cancer Care ( Site 0142)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 208-755-2804
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Illinois
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Chicago, Illinois, Forente stater, 60637
- Rekruttering
- University of Chicago Medical Center ( Site 0126)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 773-702-5550
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Peoria, Illinois, Forente stater, 61615
- Rekruttering
- Illinois Cancer Care ( Site 7005)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 309-240-6040
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- Rekruttering
- University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 319-356-4200
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Waukee, Iowa, Forente stater, 50263
- Rekruttering
- Mission Blood & Cancer Care ( Site 0114)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 515-282-2921
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Kentucky
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Edgewood, Kentucky, Forente stater, 41017
- Rekruttering
- Saint Elizabeth Medical Center Edgewood ( Site 0141)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 859-301-2000
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Elizabethtown, Kentucky, Forente stater, 42701
- Rekruttering
- Baptist Health Hardin ( Site 0154)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 270-706-5065
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Lexington, Kentucky, Forente stater, 40503
- Rekruttering
- Baptist Health Lexington ( Site 0127)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 859-260-6100
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Louisville, Kentucky, Forente stater, 40207
- Rekruttering
- Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 502-899-3366
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70808
- Rekruttering
- Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 225-374-0320
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Monroe, Louisiana, Forente stater, 71202
- Rekruttering
- Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 318-330-0000
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New Orleans, Louisiana, Forente stater, 70121
- Rekruttering
- Ochsner Clinic Foundation ( Site 0189)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 504-703-1340
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Shreveport, Louisiana, Forente stater, 71103
- Rekruttering
- Louisiana State University Health Sciences Shreveport ( Site 0195)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 318-813-1057
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Rekruttering
- Dana Farber Cancer Institute ( Site 0111)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 877-442-3324
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Boston, Massachusetts, Forente stater, 02215
- Rekruttering
- Beth Israel Deaconess Medical Center ( Site 0161)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 617-667-2100
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Minnesota
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Burnsville, Minnesota, Forente stater, 55337
- Aktiv, ikke rekrutterende
- Minnesota Oncology Hematology (MNO) ( Site 8004)
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Montana
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Bozeman, Montana, Forente stater, 59715
- Rekruttering
- Bozeman Health Deaconess Hospital ( Site 0183)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 406-414-3749
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Nebraska
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Lincoln, Nebraska, Forente stater, 68506
- Rekruttering
- NHO Revive Research Institute, LLC ( Site 0121)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 402-484-4900
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Omaha, Nebraska, Forente stater, 68198
- Rekruttering
- University Of Nebraska Medical Center ( Site 0110)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 402-559-5600
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New Jersey
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Morristown, New Jersey, Forente stater, 07960
- Rekruttering
- Atlantic Health Morristown Medical Center ( Site 0163)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 973-971-6608
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Paramus, New Jersey, Forente stater, 07652
- Rekruttering
- Valley Health Systems - Ridgewood Campus ( Site 0125)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 201-447-8000
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New York
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Buffalo, New York, Forente stater, 14263
- Rekruttering
- Roswell Park Cancer Institute ( Site 0192)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 716-845-2300
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Buffalo, New York, Forente stater, 14215
- Fullført
- Erie County Medical Center ( Site 0175)
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Mineola, New York, Forente stater, 11501
- Rekruttering
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 516-663-2988
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New York, New York, Forente stater, 10016
- Rekruttering
- Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 212-731-6000
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Syracuse, New York, Forente stater, 13210
- Rekruttering
- SUNY Upstate Cancer Center ( Site 0178)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 315-464-8200
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Westbury, New York, Forente stater, 11590
- Rekruttering
- Optum Medical Care, PC ( Site 0122)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 646-872-8630
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27514
- Rekruttering
- University of North Carolina Medical Center ( Site 0136)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 984-974-1000
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Charlotte, North Carolina, Forente stater, 28204
- Rekruttering
- Novant Health Presbyterian Medical Center ( Site 0177)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 704-384-4000
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Winston-Salem, North Carolina, Forente stater, 27103
- Rekruttering
- Novant Health Forsyth Medical Center ( Site 0206)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 336-718-5000
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- Rekruttering
- University of Cincinnati Medical Center ( Site 0156)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 513-584-1000
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Cleveland, Ohio, Forente stater, 44195
- Rekruttering
- Cleveland Clinic Main ( Site 0101)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 216-444-6833
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Cleveland, Ohio, Forente stater, 44111
- Rekruttering
- Fairview Hospital-Moll Cancer Center ( Site 0198)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 216-444-6833
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Cleveland, Ohio, Forente stater, 44106
- Rekruttering
- University Hospitals of Cleveland ( Site 0155)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 216-286-3867
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Mayfield Heights, Ohio, Forente stater, 44124
- Rekruttering
- Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 216-444-6833
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Oregon
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Portland, Oregon, Forente stater, 97213
- Rekruttering
- Providence Portland Medical Center ( Site 0120)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 503-216-6300
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Portland, Oregon, Forente stater, 97225
- Rekruttering
- Providence Oncology and Hematology Clinic Westside ( Site 0179)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 503-216-6300
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19140
- Rekruttering
- Temple University Hospital ( Site 0133)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 215-707-8712
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Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- Abramson Cancer Center and Perelman Center for Advanced Medicine ( Site 0131)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 215-662-2867
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Sellersville, Pennsylvania, Forente stater, 18960
- Rekruttering
- Alliance Cancer Specialists (ACS) ( Site 8010)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 215-706-2034
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York, Pennsylvania, Forente stater, 17403
- Rekruttering
- Cancer Care Associates Of York ( Site 0174)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 484-371-5102
-
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South Carolina
-
Charleston, South Carolina, Forente stater, 29425
- Rekruttering
- Medical University of South Carolina ( Site 0153)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 843-792-2529
-
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Tennessee
-
Knoxville, Tennessee, Forente stater, 37909
- Rekruttering
- Tennessee Cancer Specialists ( Site 7004)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 865-862-0998
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- SCRI Oncology Partners ( Site 7002)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 615-329-7274
-
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Texas
-
Amarillo, Texas, Forente stater, 79124
- Rekruttering
- Texas Oncology - West Texas ( Site 8008)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 806-358-8654
-
Austin, Texas, Forente stater, 78705
- Rekruttering
- Texas Oncology - Central/South Texas ( Site 8006)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 512-427-9400
-
Dallas, Texas, Forente stater, 75390
- Rekruttering
- UT Southwestern Medical Center ( Site 0190)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 214-648-3111
-
Palestine, Texas, Forente stater, 75801
- Rekruttering
- Texas Oncology - Northeast Texas ( Site 8002)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 903-727-2200
-
San Antonio, Texas, Forente stater, 78240
- Rekruttering
- Texas Oncology - San Antonio ( Site 8009)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 210-595-5300
-
Tyler, Texas, Forente stater, 75701
- Fullført
- The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145)
-
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Utah
-
Murray, Utah, Forente stater, 84107
- Rekruttering
- Intermountain Medical Center ( Site 0182)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 801-507-3630
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St. George, Utah, Forente stater, 84790
- Rekruttering
- Intermountain Healthcare - St. George ( Site 0203)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 801-507-3630
-
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Virginia
-
Manassas, Virginia, Forente stater, 20110
- Rekruttering
- Virginia Cancer Specialists, PC ( Site 8003)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 703-554-6800
-
Richmond, Virginia, Forente stater, 23219
- Rekruttering
- VCU Health Adult Outpatient Pavillion ( Site 0138)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 315-383-8748
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Washington
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Vancouver, Washington, Forente stater, 98684
- Rekruttering
- Northwest Cancer Specialists (Compass Oncology) ( Site 8000)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 360-944-9889
-
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Wisconsin
-
Madison, Wisconsin, Forente stater, 53715
- Rekruttering
- SSM Health Dean Medical Group ( Site 0106)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 608-252-8000
-
Milwaukee, Wisconsin, Forente stater, 53226
- Rekruttering
- Medical College of Wisconsin ( Site 0103)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 414-805-6700
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-
-
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Dublin, Irland, D07 R2WY
- Rekruttering
- Mater Misercordiae University Hospital ( Site 0501)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +353 1 8034831
-
Dublin, Irland, D08 E9P6
- Rekruttering
- St. James's Hospital ( Site 0505)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 014284934
-
Dublin, Irland, D09 V2N0
- Rekruttering
- Beaumont Hospital ( Site 0506)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 018092010
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Limerick, Irland, V94 F858
- Rekruttering
- University Hospital Limerick ( Site 0503)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4461301111
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Waterford, Irland, X91 ER8E
- Rekruttering
- University Hospital Waterford ( Site 0504)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +35351848000
-
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Dublin
-
Dublin, Dublin, Irland, D04 T6F4
- Rekruttering
- St Vincent's University Hospital ( Site 0502)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +35312214000
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-
-
-
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Beersheba, Israel, 8410101
- Rekruttering
- Soroka Medical Center ( Site 0606)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +97286400111
-
Haifa, Israel, 3109601
- Rekruttering
- Rambam Health Care Campus ( Site 0604)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +972-47771514
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Holon, Israel, 5810001
- Rekruttering
- Edith Wolfson Medical Center ( Site 0602)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +972-508805538
-
Jerusalem, Israel, 9112001
- Rekruttering
- Haddasah Medical Center ( Site 0601)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +97239377377
-
Petah Tikva, Israel, 4941492
- Rekruttering
- Rabin Medical Center ( Site 0607)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +97239377377
-
Ramat Gan, Israel, 5265601
- Rekruttering
- Sheba Medical Center ( Site 0603)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +972-35302127
-
Safed, Israel, 13100
- Rekruttering
- ZIV Medical Center ( Site 0605)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +972-46828132
-
Tel Aviv, Israel, 6423906
- Rekruttering
- Sourasky Medical Center ( Site 0608)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 972-3-6973576
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-
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Alessandria, Italia, 15121
- Rekruttering
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0703)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390131206262
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Milan, Italia, 20141
- Rekruttering
- Istituto Europeo di Oncologia ( Site 0701)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0390257489403
-
Naples, Italia, 80131
- Rekruttering
- Universita degli Studi di Napoli Federico II ( Site 0705)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390817462037
-
Reggio Emilia, Italia, 42123
- Rekruttering
- Arcispedale Santa Maria Nuova ( Site 0706)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +39 0522295654
-
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Forli-Cesena
-
Meldola, Forli-Cesena, Italia, 47014
- Rekruttering
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0707)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390543739266
-
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Milano
-
Rozzano, Milano, Italia, 20089
- Rekruttering
- Istituto Clinico Humanitas ( Site 0704)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390282244540
-
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Sicily
-
Palermo, Sicily, Italia, 90146
- Rekruttering
- Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390917802047
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Nagasaki, Japan, 852-8501
- Rekruttering
- Nagasaki University Hospital ( Site 1008)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-95-819-7256
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 464-8681
- Rekruttering
- Aichi Cancer Center ( Site 1007)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-52-762-6111
-
Toyoake, Aichi-ken, Japan, 470-1192
- Rekruttering
- Fujita Health University Hospital ( Site 1003)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-562-93-2111
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8648
- Rekruttering
- Hokkaido University Hospital ( Site 1004)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-11-716-1161
-
-
Miyagi
-
Sendai, Miyagi, Japan, 983-8520
- Rekruttering
- National Hospital Organization Sendai Medical Center ( Site 1005)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-22-293-1111
-
-
Osaka
-
Hirakata, Osaka, Japan, 573-1191
- Rekruttering
- Kansai Medical University Hospital ( Site 1006)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-72-804-2808
-
-
Shimane
-
Izumo, Shimane, Japan, 693-8501
- Rekruttering
- Shimane University Hospital ( Site 1002)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-853-20-2492
-
-
Tokyo
-
Bunkyo, Tokyo, Japan, 113-8603
- Rekruttering
- Nippon Medical School Hospital ( Site 1001)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-3-3822-2131
-
Chūō, Tokyo, Japan, 104-0045
- Rekruttering
- National Cancer Center Hospital ( Site 1009)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-3-3542-2511
-
-
-
-
Greater Poland Voivodeship
-
Skórzewo, Greater Poland Voivodeship, Polen, 60-185
- Rekruttering
- AIDPORT Sp. z o.o. ( Site 0808)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48570783100
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Polen, 30-727
- Rekruttering
- Pratia MCM Krakow ( Site 0804)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48 12 295 81 60
-
Nowy Sącz, Lesser Poland Voivodeship, Polen, 33-300
- Rekruttering
- Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48 18 443 88 77
-
-
Lower Silesian Voivodeship
-
Wałbrzych, Lower Silesian Voivodeship, Polen, 58-309
- Rekruttering
- Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0807)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48746489742
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen, 02-781
- Rekruttering
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 225462223
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Polen, 80-214
- Rekruttering
- Uniwersyteckie Centrum Kliniczne ( Site 0802)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48 58 584 43 57
-
-
Silesian Voivodeship
-
Katowice, Silesian Voivodeship, Polen, 40-519
- Rekruttering
- Pratia Onkologia Katowice ( Site 0801)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48 501 714 019
-
-
-
-
-
Birmingham, Storbritannia, B15 2TH
- Rekruttering
- Queen Elizabeth Hospital Birmingham ( Site 0912)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441213717842
-
Liverpool, Storbritannia, L7 8YA
- Rekruttering
- Clatterbridge Cancer Centre - Liverpool ( Site 0911)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441515565000
-
Manchester, Storbritannia, M20 4BX
- Rekruttering
- Christie Hospital NHS Trust ( Site 0901)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441619187222
-
-
Bristol, City of
-
Bristol, Bristol, City of, Storbritannia, BS2 8ED
- Rekruttering
- Bristol Haematology and Oncology Centre ( Site 0908)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441179230000
-
-
Buckinghamshire
-
Aylesbury, Buckinghamshire, Storbritannia, HP21 8AL
- Rekruttering
- Stoke Mandeville Hospital ( Site 0917)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441296315000
-
-
Devon
-
Exeter, Devon, Storbritannia, EX2 5DW
- Rekruttering
- Royal Devon & Exeter Hospital ( Site 0910)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 01392402850
-
Plymouth, Devon, Storbritannia, PL68DH
- Rekruttering
- University Hospitals Plymouth NHS Trust ( Site 0905)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441752431043
-
-
England
-
Middlesbrough, England, Storbritannia, TS4 3BW
- Rekruttering
- The James Cook University Hospital ( Site 0909)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441642850850
-
-
Lincolnshire
-
Lincoln, Lincolnshire, Storbritannia, LN2 5QY
- Rekruttering
- Lincoln County Hospital ( Site 0906)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441522573557
-
-
London, City of
-
London, London, City of, Storbritannia, W12 0 HS
- Rekruttering
- Hammersmith Hospital ( Site 0915)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +442033134594
-
London, London, City of, Storbritannia, SE1 9RT
- Rekruttering
- Guy s & St Thomas NHS Foundation Trust ( Site 0904)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +442071887188
-
-
Oxfordshire
-
Oxford, Oxfordshire, Storbritannia, OX3 7LJ
- Rekruttering
- Churchill Hospital ( Site 0903)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +441865227063
-
-
-
-
Baden-Wurttemberg
-
Stuttgart, Baden-Wurttemberg, Tyskland, 70174
- Rekruttering
- Klinikum Stuttgart. Klinik fur Hamatologie. Onkologie. Palliativmedizin und Stammzelltransplantation ( Site 0419)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4971127830410
-
Tübingen, Baden-Wurttemberg, Tyskland, 72076
- Rekruttering
- UniversitaetsklInikum Tuebingen ( Site 0410)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4970712986018
-
Ulm, Baden-Wurttemberg, Tyskland, 89081
- Rekruttering
- Universitaetsklinikum Ulm. ( Site 0404)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +49 731500 45 953
-
-
Bavaria
-
Erlangen, Bavaria, Tyskland, 91054
- Rekruttering
- Uniklinik Erlangen ( Site 0412)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4991318535954
-
Munich, Bavaria, Tyskland, 81377
- Rekruttering
- LMU Klinikum ( Site 0428)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 089440075212
-
Würzburg, Bavaria, Tyskland, 97080
- Rekruttering
- Universitaetsklinikum Wuerzburg ( Site 0401)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4993120140013
-
-
Hesse
-
Frankfurt am Main, Hesse, Tyskland, 60389
- Rekruttering
- Centrum für Hämatologie und Onkologie Bethanien ( Site 0417)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4969451080
-
Kassel, Hesse, Tyskland, 34125
- Rekruttering
- Klinikum Kassel GmbH ( Site 0434)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +495619803046
-
-
Lower Saxony
-
Hanover, Lower Saxony, Tyskland, 30459
- Rekruttering
- KRH Klinikum Siloah ( Site 0441)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4905119270
-
-
Mecklenburg-Vorpommern
-
Neubrandenburg, Mecklenburg-Vorpommern, Tyskland, 17036
- Rekruttering
- Dietrich Bonhoeffer Klinikum-Neubrandenburg ( Site 0439)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +493957750
-
-
North Rhine-Westphalia
-
Aachen, North Rhine-Westphalia, Tyskland, 52074
- Rekruttering
- Universitätsklinikum Aachen ( Site 0418)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0241 800
-
Bonn, North Rhine-Westphalia, Tyskland, 53113
- Rekruttering
- Johanniter Krankenhaus Bonn ( Site 0440)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +492285433691
-
Wuppertal, North Rhine-Westphalia, Tyskland, 42283
- Rekruttering
- HELIOS Klinikum Wuppertal ( Site 0435)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +492028960
-
-
Rhineland-Palatinate
-
Koblenz, Rhineland-Palatinate, Tyskland, 56073
- Rekruttering
- Gemeinschaftsklinikum Mittelrhein gGmbH Innere Medizin - Hamatologie/Onkologie.Palliativmedizin ( Site 0413)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 06772 8040
-
-
Saxony
-
Chemnitz, Saxony, Tyskland, 09113
- Rekruttering
- Klinikum Chemnitz gGmbH ( Site 0405)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 01732988725
-
-
Saxony-Anhalt
-
Magdeburg, Saxony-Anhalt, Tyskland, 39120
- Rekruttering
- Otto-Von-Guericke-Universitaet Magdeburg ( Site 0411)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 01732988725
-
-
Schleswig-Holstein
-
Lübeck, Schleswig-Holstein, Tyskland, 23562
- Rekruttering
- Universitaetsklinikum Schleswig-Holstein - Campus Luebeck ( Site 0425)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +4945150044777
-
-
Thuringia
-
Jena, Thuringia, Tyskland, 07747
- Rekruttering
- Universitätsklinikum Jena ( Site 0438)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +493641 9327113
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues.
- Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.
- Has received no prior treatment for their DLBCL.
- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has a history of transformation of indolent disease to DLBCL.
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma.
- Has Ann Arbor Stage I DLBCL.
- Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
- Has clinically significant pericardial or pleural effusion.
- Has ongoing Grade >1 peripheral neuropathy.
- Has a demyelinating form of Charcot-Marie-Tooth disease.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has ongoing corticosteroid therapy.
- Known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Known active central nervous system (CNS) lymphoma.
- Has active autoimmune disease that has required systemic treatment in the past 2 years.
- Has active infection requiring systemic therapy.
- Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
- Has history of stem cell/solid organ transplant.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)
Participants will receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 375 mg/m^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months). |
IV infusion
Andre navn:
IV infusion
Andre navn:
IV infusion
Andre navn:
IV infusion
Andre navn:
IV infusion
Andre navn:
Oral administration or IV infusion Oral administration or IV infusion Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF). |
|
Aktiv komparator: Polatuzumab vedotin + R-CHP
Participants will receive a dose of polatuzumab vedotin (1.8 mg/kg) plus 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 375 mg/m^2 rituximab or rituximab biosimilar administered by IV infusion on Day 1 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months). |
IV infusion
Andre navn:
IV infusion
Andre navn:
IV infusion
Andre navn:
IV infusion
Andre navn:
Oral administration or IV infusion Oral administration or IV infusion Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF). IV infusion |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria
Tidsramme: Up to approximately 31 months
|
CRR at EOT is defined as the percentage of participants who experience complete response (CR) per Lugano response criteria as assessed by blinded independent central review (BICR) at end of treatment. CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Participants with missing data or who discontinue treatment or study prior to reaching EOT will be considered non-responders and included in the total number of participants. |
Up to approximately 31 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival (PFS) per Lugano Response Criteria
Tidsramme: Up to approximately 51 months
|
PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by BICR or death due to any cause, whichever occurs first. |
Up to approximately 51 months
|
|
Overall Survival (OS)
Tidsramme: Up to approximately 87 months
|
OS is defined as the time from randomization to death due to any cause. |
Up to approximately 87 months
|
|
Event-free Survival (EFS) per Lugano Response Criteria
Tidsramme: Up to approximately 51 months
|
EFS is defined as the time from randomization to any of the following events: progressive disease per Lugano response criteria by BICR, death due to any cause, initiation of a new anti-caner therapy, or a positive biopsy for residual disease. The EFS for all participants will be presented. |
Up to approximately 51 months
|
|
Duration of CR
Tidsramme: Up to approximately 51 months
|
For participants who demonstrate CR at EOT per Lugano response criteria by BICR, duration of complete response is defined as the time from the first documented evidence of CR at or before EOT until disease progression or death due to any cause, whichever occurs first. |
Up to approximately 51 months
|
|
Number of participants who experience one or more adverse events (AEs)
Tidsramme: Up to approximately 9 months
|
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented. |
Up to approximately 9 months
|
|
Number of participants who discontinue study intervention due to an AE
Tidsramme: Up to approximately 6 months
|
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented. |
Up to approximately 6 months
|
|
Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI)
Tidsramme: Baseline and up to Week 25
|
The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life. |
Baseline and up to Week 25
|
|
Change From Baseline in HRQoL on FACT-Lym Total Score
Tidsramme: Baseline and up to Week 25
|
The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life. |
Baseline and up to Week 25
|
|
Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 through GP7)
Tidsramme: Baseline and up to Week 25
|
The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life. |
Baseline and up to Week 25
|
|
Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score
Tidsramme: Baseline and up to Week 25
|
The FACT/GOG-NTX provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. It is an 11-item questionnaire designed to measure the neurotoxicity subscale. The scoring of FACT/GOG-NTX is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. To produce a Neurotoxicity Subscale score (range 0-44), the sum of the item scores are multiplied by the number of items in the subscale, then divided by the number of items answered. |
Baseline and up to Week 25
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. april 2025
Primær fullføring (Antatt)
13. desember 2027
Studiet fullført (Antatt)
16. desember 2032
Datoer for studieregistrering
Først innsendt
20. mars 2025
Først innsendt som oppfylte QC-kriteriene
20. mars 2025
Først lagt ut (Faktiske)
24. mars 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Lymfesykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom, B-celle
- Lymfom
- Hemic og lymfatiske sykdommer
- Lymfom, stor B-celle, diffus
- Aminosyrer, peptider og proteiner
- Proteiner
- Organiske kjemikalier
- Hydrokarboner
- Hydrokarboner, syklisk
- Karbohydrater
- Polysykliske aromatiske hydrokarboner
- Hydrokarboner, aromatisk
- Polysykliske forbindelser
- Glykosider
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Gravadienes
- Gravaner
- Steroider
- Smeltede ringforbindelser
- Fosforamid -sennep
- Nitrogen sennepsforbindelser
- Sennepsforbindelser
- Hydrokarboner, halogenert
- Fosforamider
- Organofosforforbindelser
- Gravadienetrioler
- Gravadienedioler
- Antracykliner
- Naphthacenes
- Aminoglykosider
- Antistoffer, monoklonale, murine-avledede
- Daunorubicin
- Rituximab
- Prednison
- Prednisolon
- Cyklofosfamid
- Doxorubicin
- Polatuzumab Vedotin
Andre studie-ID-numre
- 2140-011
- U1111-1309-2852 (Registeridentifikator: UTN)
- MK-2140-011 (Annen identifikator: MSD)
- waveLINE-011 (Annen identifikator: MSD)
- 2024-515526-89-00 (Registeridentifikator: EU CT)
- jRCT2021250001 (Registeridentifikator: Japan Registry of Clinical Trials (jRCT))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .