En undersøgelse af AZD0486 Plus Rituximab hos tidligere ubehandlede follikulært lymfompatienter
20. oktober 2026 opdateret af: AstraZeneca
Et fase III, multicenter, randomiseret, åbent studie for at sammenligne effektiviteten og sikkerheden af AZD0486 Plus Rituximab versus Kemoterapi Plus Rituximab hos tidligere ubehandlede deltagere med follikulært lymfom
This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study consists of 2 sequential parts.
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Safety Run-in - this part will compare dose levels of Surovatamig (AZD0486) in combination with rituximab in order to establish the RP3D.
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Phase III - The Phase III part will assess the superiority of Surovatamig (AZD0486) at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms
- Arm A: treatment with Surovatamig plus rituximab Schedule A
- Arm B: treatment with Surovatamig plus rituximab Schedule B
- Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance or B-R + rituximab maintenance
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1018
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Studiesteder
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Clayton, Australien, 3168
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Darlinghurst, Australien, 2010
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Garran, Australien, 2605
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Heidelberg, Australien, 3084
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Macquarie University, Australien, 2109
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Nedlands, Australien, 6009
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Brussels, Belgien, 1070
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Brussels, Belgien, 1090
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Ghent, Belgien, 9000
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Mechelen, Belgien, 2800
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Porto Alegre, Brasilien, 90035-003
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São Paulo, Brasilien, 04501-000
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São Paulo, Brasilien, 05652-900
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Ontario
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Barrie, Ontario, Canada, L4M 6M2
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Hamilton, Ontario, Canada, L8V 5C2
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Oshawa, Ontario, Canada, L1G 2B9
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Toronto, Ontario, Canada, M5G 1X6
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
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Montreal, Quebec, Canada, H4J 1C5
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Québec, Quebec, Canada, G1J 1Z4
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Saint-Jérôme, Quebec, Canada, J7Z 2V4
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Aalborg, Danmark, 9100
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Copenhagen, Danmark, 2100
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Odense C, Danmark, 5000
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Roskilde, Danmark, 4000
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London, Det Forenede Kongerige, SE5 9RS
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London, Det Forenede Kongerige, EC1M6BQ
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Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
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Norwich, Det Forenede Kongerige, NR4 7UY
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Nottingham, Det Forenede Kongerige, NG5 1PB
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Plymouth, Det Forenede Kongerige, PL6 8DH
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Southampton, Det Forenede Kongerige, SO16 6YD
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Helsinki, Finland, 00029
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Kuopio, Finland, 70029
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Tampere, Finland, 33520
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Alabama
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Huntsville, Alabama, Forenede Stater, 35805
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
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California
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Clovis, California, Forenede Stater, 93611
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Los Alamitos, California, Forenede Stater, 90720
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San Diego, California, Forenede Stater, 92121
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Santa Monica, California, Forenede Stater, 90404
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
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Delaware
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Newark, Delaware, Forenede Stater, 19713
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
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Macon, Georgia, Forenede Stater, 31201
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Illinois
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Evanston, Illinois, Forenede Stater, 60201
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Peoria, Illinois, Forenede Stater, 61615
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46804
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Iowa
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Des Moines, Iowa, Forenede Stater, 50309
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Iowa City, Iowa, Forenede Stater, 52242
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
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Louisville, Kentucky, Forenede Stater, 40207
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70808
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
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Bethesda, Maryland, Forenede Stater, 20817
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Columbia, Maryland, Forenede Stater, 21044
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
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Boston, Massachusetts, Forenede Stater, 02215
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
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Detroit, Michigan, Forenede Stater, 48201
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Ypsilanti, Michigan, Forenede Stater, 48197
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
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Saint Paul, Minnesota, Forenede Stater, 55102
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Missouri
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Chesterfield, Missouri, Forenede Stater, 63017
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Springfield, Missouri, Forenede Stater, 65807
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
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New Brunswick, New Jersey, Forenede Stater, 08901
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New York
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Albany, New York, Forenede Stater, 12206
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Brooklyn, New York, Forenede Stater, 11220
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Mineola, New York, Forenede Stater, 11501
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New Hyde Park, New York, Forenede Stater, 11042
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New York, New York, Forenede Stater, 10065
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New York, New York, Forenede Stater, 10032
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New York, New York, Forenede Stater, 10016
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
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Charlotte, North Carolina, Forenede Stater, 28204
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Wilmington, North Carolina, Forenede Stater, 28401
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Winston-Salem, North Carolina, Forenede Stater, 27103
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Ohio
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Blue Ash, Ohio, Forenede Stater, 45242
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Cincinnati, Ohio, Forenede Stater, 45219
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Columbus, Ohio, Forenede Stater, 43210
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
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Portland, Oregon, Forenede Stater, 97227
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
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Texas
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Austin, Texas, Forenede Stater, 78705
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Lubbock, Texas, Forenede Stater, 79430
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Shenandoah, Texas, Forenede Stater, 77380
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Tyler, Texas, Forenede Stater, 75702
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
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Richmond, Virginia, Forenede Stater, 23219
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Washington
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Tacoma, Washington, Forenede Stater, 98405
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
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Milwaukee, Wisconsin, Forenede Stater, 53226
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Bayonne, Frankrig, 64100
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La Tronche, Frankrig, 38700
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Lille, Frankrig, 59037
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Montpellier, Frankrig, 34295
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Saint-Cloud, Frankrig, 92210
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Vandœuvre-lès-Nancy, Frankrig, 54511
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Hong Kong, Hong Kong, 999077
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Delhi, Indien, 110029
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Delhi, Indien, 110085
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Gurugram, Indien, 122002
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Kolkata, Indien, 700160
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Nashik, Indien, 422002
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Surat, Indien, 396007
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Thiruvananthapuram, Indien, 695011
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Bologna, Italien, 40138
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Milan, Italien, 20141
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Reggio Emilia, Italien, 42100
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Bunkyō City, Japan, 113-8677
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Chiba, Japan, 260-8717
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Chuo-shi, Japan, 409-3898
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Fukuoka, Japan, 812-8582
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Hirakata-shi, Japan, 573-1191
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Kobe, Japan, 650-0047
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Kumamoto, Japan, 860-8556
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Kurashiki-shi, Japan, 710-8602
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Kyoto, Japan, 602-8566
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Kōtoku, Japan, 135-8550
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Minatoku, Japan, 105-8470
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Okayama, Japan, 700-8558
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Osaka, Japan, 541-8567
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Sapporo, Japan, 060-8638
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Sapporo, Japan, 003-0006
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Sunto-gun, Japan, 411-8777
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Toyoake-shi, Japan, 470-1192
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Yamagata, Japan, 990-9585
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Yokohama, Japan, 241-8515
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Beijing, Kina, 100730
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Beijing, Kina, 100044
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Beijing, Kina, 100142
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Changchun, Kina, 130021
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Changsha, Kina, 410013
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Chengdu, Kina, 610078
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Chongqing, Kina, 400030
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Fuzhou, Kina, 350001
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Guangzhou, Kina, 510060
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Guangzhou, Kina, 510100
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Guangzhou, Kina, 510000
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Hangzhou, Kina, 310022
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Hangzhou, Kina, 310003
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Harbin, Kina, 150081
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Hefei, Kina, 230031
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Lanzhou, Kina, 730000
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Nanchang, Kina, 330006
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Nanchang, Kina, 330029
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Nanjing, Kina, 210029
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Nanning, Kina, 530021
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Shandong, Kina, 250117
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Shanghai, Kina, 200065
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Shanghai, Kina, 20032
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Shenyang, Kina, 110001
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Shenyang, Kina, 110004
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Shijiazhuang, Kina, 054001
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Suzhou, Kina, 215006
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Tianjin, Kina, 300020
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Wenzhou, Kina, 325000
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Wuhan, Kina, 430079
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Xi'an, Kina, 710114
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Xiamen, Kina, 361003
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Zhengzhou, Kina, 450000
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Zhengzhou, Kina, 450008
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Gdansk, Polen, 80-214
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Gliwice, Polen, 44-102
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Katowice, Polen, 40-519
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Krakow, Polen, 30-727
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Lublin, Polen, 20-081
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Lublin, Polen, 20-090
- Suspenderet
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Warsaw, Polen, 02-781
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Wroclaw, Polen, 50-019
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Wroclaw, Polen, 53-439
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San Juan, Puerto Rico, 00918
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Barcelona, Spanien, 08035
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Barcelona, Spanien, 8036
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El Palmar, Spanien, 30120
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Girona, Spanien, 17007
- Ikke rekrutterer endnu
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Las Palmas de Gran Canaria, Spanien, 35020
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Madrid, Spanien, 28041
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Madrid, Spanien, 28040
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Oviedo, Spanien, 33011
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Pamplona, Spanien, 31008
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Santander, Spanien, 39008
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Falun, Sverige, 79182
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Uppsala, Sverige, 75185
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Busan, Sydkorea, 49201
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Busan, Sydkorea, 49241
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Goyang-si, Sydkorea, 10408
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Jeonnam, Sydkorea, 519-763
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Seoul, Sydkorea, 03080
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Seoul, Sydkorea, 06351
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Seoul, Sydkorea, 05505
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Seoul, Sydkorea, 03722
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Seoul, Sydkorea, 06591
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Changhua, Taiwan, 50006
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Kaohsiung City, Taiwan, 80756
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Kaohsiung City, Taiwan, 833
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Lukang Township, Taiwan, 505029
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Tainan, Taiwan, 704
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Taipei, Taiwan, 106
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Bangkok, Thailand, 10330
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Bangkok, Thailand, 10700
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Chiang Mai, Thailand, 50200
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Khon Kaen, Thailand, 40002
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Brno, Tjekkiet, 625 00
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Hradec Králové, Tjekkiet, 500 05
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Prague, Tjekkiet, 12808
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Ankara, Tyrkiet (Türkiye), 6200
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Ankara, Tyrkiet (Türkiye), 6620
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Istanbul, Tyrkiet (Türkiye), 34890
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Istanbul, Tyrkiet (Türkiye), 34010
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Izmir, Tyrkiet (Türkiye), 35340
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Berlin, Tyskland, 10967
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Berlin, Tyskland, 13353
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Deggendorf, Tyskland, 94469
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Düsseldorf, Tyskland, 40479
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Göttingen, Tyskland, 37075
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Hamburg, Tyskland, 20246
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Heidelberg, Tyskland, 69120
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Jena, Tyskland, 07747
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Karlsruhe, Tyskland, 76133
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Kiel, Tyskland, 24105
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Lübeck, Tyskland, 23538
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- Research Site
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Magdeburg, Tyskland, 39120
- Ikke rekrutterer endnu
- Research Site
-
Minden, Tyskland, 32429
- Ikke rekrutterer endnu
- Research Site
-
München, Tyskland, 81377, DE
- Ikke rekrutterer endnu
- Research Site
-
Münster, Tyskland, 48129
- Ikke rekrutterer endnu
- Research Site
-
Regensburgs, Tyskland, 93049
- Ikke rekrutterer endnu
- Research Site
-
Würzburg, Tyskland, 97080
- Ikke rekrutterer endnu
- Research Site
-
-
-
-
-
Budapest, Ungarn, 1122
- Trukket tilbage
- Research Site
-
Budapest, Ungarn, 1088
- Trukket tilbage
- Research Site
-
Debrecen, Ungarn, 4032
- Ikke rekrutterer endnu
- Research Site
-
Győr, Ungarn, 9024
- Ikke rekrutterer endnu
- Research Site
-
Kaposvár, Ungarn, 7400
- Ikke rekrutterer endnu
- Research Site
-
Nyíregyháza, Ungarn, 4400
- Trukket tilbage
- Research Site
-
Pécs, Ungarn, 7624
- Ikke rekrutterer endnu
- Research Site
-
Szeged, Ungarn, 6725
- Ikke rekrutterer endnu
- Research Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 130 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
- Histologically confirmed diagnosis of classic FL per WHO 2022 classification
- ECOG performance status of 0 to 2
- No prior systemic lymphoma-directed therapy
- Need for systemic treatment meeting at least 1 GELF criteria
- FDG-avid and measurable disease
- Stage II to IV and FLIPI 2-5 [Phase III only]
- Adequate liver, hematological, renal and cardiac function.
The above is a summary, other inclusion criteria details may apply
Exclusion Criteria:
- Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
- Contra-indication to BR, RCVP, and R-CHOP
- Participants with or history of CNS lymphoma
- History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety
- Presence of >5000 circulating lymphoma cells
- Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment
- Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
The above is a summary, other exclusion criteria details may apply
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Rituximab, Surovatamig - A
Surovatamig regimen A plus rituximab |
a fully human bispecific monoclonal IgG4 antibody
Andre navne:
|
|
Eksperimentel: Rituximab, Surovatamig - B
Surovatamig regimen B plus rituximab |
a fully human bispecific monoclonal IgG4 antibody
Andre navne:
|
|
Aktiv komparator: Chemoimmunotherapy
Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP, R-CVP, or B-R followed by rituximab maintenance) |
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone Rituximab, Cyclophosphamide, Vincristine and Prednisone Bendamustine, Rituximab |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs
Tidsramme: Up to 10 years
|
Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in physical examination and safety procedures. |
Up to 10 years
|
|
SRI Primary: Determination of the recommended Phase III dose (RP3D)
Tidsramme: Up to 1 year
|
The RP3D will be the dose of Surovatamig selected for the Phase 3 part based on safety data compiled during the safety run-in part |
Up to 1 year
|
|
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy
Tidsramme: Up to 10 years
|
PFS, based on Lugano 2014 Response Criteria, as assessed by BICR. |
Up to 10 years
|
|
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy
Tidsramme: Up to 10 years
|
ORR at EoI, based on Lugano 2014 Response Criteria, as assessed by BICR. |
Up to 10 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety Run in and Phase 3: ORR at EoI (Investigator assessed)
Tidsramme: Up to 10 years
|
ORR defined as the proportion of participants achieving either a PR or CR at End of Induction based on Lugano 2014 Response Criteria |
Up to 10 years
|
|
Safety Run In and Phase 3: CR Rate
Tidsramme: Up to 10 years
|
CR rate is defined as the proportion of participants achieving a CR at any time as based on Lugano 2014 Response Criteria |
Up to 10 years
|
|
Safety Run In and Phase 3: CR at EoI
Tidsramme: Up to 10 years
|
Proportion of participants achieving CR at End of Induction based on Lugano 2014 Response Criteria |
Up to 10 years
|
|
Safety Run In and Phase 3: DoR
Tidsramme: up to 10 years
|
DoR will be defined from the time of first response until progression based on Lugano 2014 criteria, or death due to any cause |
up to 10 years
|
|
Safety Run In and Phase 3: PFS (Investigator assessed)
Tidsramme: Up to 10 years
|
PFS (Investigator assessed) is defined as time from randomization until disease progression based on Lugano 2014 Response Criteria or death due to any cause |
Up to 10 years
|
|
Safety Run In and Phase 3: OS
Tidsramme: Up to 10 years
|
OS is defined as time until the date of death |
Up to 10 years
|
|
Phase 3: CR rate at 30 months (CR30)
Tidsramme: Up to 30 months
|
Proportion of participants in CR rate at 30 months (CR30) based on Lugano 2014 Response Criteria |
Up to 30 months
|
|
Phase 3: Time to First Subsequent Therapy or Death (TFST)
Tidsramme: Up to 10 Years
|
TFST will be defined as the time from randomization until the start date of first subsequent anti-lymphoma therapy or death due to any cause |
Up to 10 Years
|
|
Phase 3: Time from randomisation to second progression or death (PFS2)
Tidsramme: Up to 10 Years
|
PFS2 will be defined as the time from randomization until the earliest of the progression event, after first subsequent therapy, or death due to any cause |
Up to 10 Years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Chan Cheah, MBBS FRACP FRCPA DMSc, Sir Charles Gairdner Hospital (SCGH)
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
7. august 2024
Primær færdiggørelse (Anslået)
26. november 2031
Studieafslutning (Anslået)
26. november 2031
Datoer for studieregistrering
Først indsendt
29. juli 2024
Først indsendt, der opfyldte QC-kriterier
7. august 2024
Først opslået (Faktiske)
12. august 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D7401C00001
- 2023 (U.S. NIH-bevilling/kontrakt)
- 2023-510098-33-00 (Registry Identifier: CTIS (EU))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD-delingstidsramme
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD-delingsadgangskriterier
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .