Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)

February 10, 2026 updated by: Celgene

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)

The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Local Institution - 0112
      • Buenos Aires, Argentina, C1431FWO
        • Local Institution - 0136
      • Buenos Aires, Argentina, C1426ANZ
        • Local Institution - 0119
      • Córdoba, Argentina, 5016
        • Local Institution - 0111
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1118AAT
        • Local Institution - 0113
      • Buenos Aires, Buenos Aires F.D., Argentina, C1417DTB
        • Local Institution - 0421
  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Local Institution - 0357
      • Sydney, New South Wales, Australia, 2560
        • Local Institution - 0361
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0358
    • Northern Territory
      • Tiwi, Northern Territory, Australia, 0810
        • Local Institution - 0363
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Local Institution - 0356
      • Southport, Queensland, Australia, 4215
        • Local Institution - 0360
    • Victoria
      • Frankston, Victoria, Australia, 3195
        • Local Institution - 0365
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0362
      • St Albans, Victoria, Australia, 3021
        • Local Institution - 0359
      • Warrnambool, Victoria, Australia, 3280
        • Local Institution - 0364
  • Austria
      • Linz, Austria, 4020
        • Local Institution - 0387
      • Vienna, Austria, 1140
        • Local Institution - 0386
    • Upper Austria
      • Wels, Upper Austria, Austria, 4600
        • Local Institution - 0385
  • Brazil
      • Rio de Janeiro, Brazil, 22061-080
        • Local Institution - 0298
      • São Paulo, Brazil, 05652-900
        • Local Institution - 0251
      • São Paulo, Brazil, 01409-901
        • Local Institution - 0294
      • São Paulo, Brazil, 04543-000
        • Local Institution - 0252
      • São Paulo, Brazil, 05403-000
        • Local Institution - 0317
    • Ceará
      • Fortaleza, Ceará, Brazil, 60115-281
        • Local Institution - 0255
    • Federal District
      • Lago Sul, Federal District, Brazil, 71635580
        • Local Institution - 0297
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-020
        • Local Institution - 0256
    • Paraná
      • Curitiba, Paraná, Brazil, 81520-060
        • Local Institution - 0302
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075-740
        • Local Institution - 0304
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
        • Local Institution - 0253
    • Rio de Janeiro
      • Niterói, Rio de Janeiro, Brazil, 24020-096
        • Local Institution - 0296
    • Santa Catarina
      • Chapecó, Santa Catarina, Brazil, 89812-210
        • Local Institution - 0246
      • Joinville, Santa Catarina, Brazil, 89201260
        • Local Institution - 0247
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784400
        • Local Institution - 0250
      • Jaú, São Paulo, Brazil, 17210-120
        • Local Institution - 0249
      • São José do Rio Preto, São Paulo, Brazil, 15090000
        • Local Institution - 0301
      • São Paulo, São Paulo, Brazil, 01323-903
        • Local Institution - 0248
      • São Paulo, São Paulo, Brazil, 01509-010
        • Local Institution - 0316
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Local Institution - 0393
      • Sofia, Bulgaria, 1407
        • Local Institution - 0392
      • Sofia, Bulgaria, 1431
        • Local Institution - 0394
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
        • Local Institution - 0091
    • Quebec
      • Montreal, Quebec, Canada, H3T 1M5
        • Local Institution - 0153
      • Montreal, Quebec, Canada, H4J 1C5
        • Local Institution - 0073
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution - 0004
  • Chile
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile
        • Local Institution - 0164
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Local Institution - 0459
      • Santiago, Santiago Metropolitan, Chile, 7500921
        • Local Institution - 0106
      • Santiago, Santiago Metropolitan, Chile, 7580206
        • Local Institution - 0107
      • Santiago, Santiago Metropolitan, Chile, 7620002
        • Local Institution - 0108
      • Santiago, Santiago Metropolitan, Chile, 8320325
        • Local Institution - 0110
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100091
        • Local Institution - 0195
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Local Institution - 0236
      • Chongqing, Chongqing Municipality, China, 400030
        • Local Institution - 0196
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Local Institution - 0274
      • Xiamen, Fujian, China, 361003
        • Local Institution - 0157
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Local Institution - 0133
      • Guangzhou, Guangdong, China, 510555
        • Local Institution - 0240
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Local Institution - 0338
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Local Institution - 0239
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Local Institution - 0238
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Local Institution - 0346
      • Wuhan, Hubei, China, 430030
        • Local Institution - 0214
    • Hunan
      • Changsha, Hunan, China, 410013
        • Local Institution - 0275
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Local Institution - 0156
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Local Institution - 0237
      • Nanchang, Jiangxi, China, 330029
        • Local Institution - 0241
    • Jilin
      • Changchun, Jilin, China, 130021
        • Local Institution - 0291
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Local Institution - 0334
      • Shenyang, Liaoning, China, 110015
        • Local Institution - 0169
    • Shandong
      • Jinan, Shandong, China, 250012
        • Local Institution - 0242
      • Jinan, Shandong, China, 250117
        • Local Institution - 0344
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Local Institution - 0132
      • Shanghai, Shanghai Municipality, China, 200032
        • Local Institution - 0339
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Local Institution - 0234
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0141
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Local Institution - 0470
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Local Institution - 0467
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Local Institution - 0197
      • Hangzhou, Zhejiang, China, 310052
        • Local Institution - 0483
      • Wenzhou, Zhejiang, China, 325000
        • Local Institution - 0457
  • Colombia
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110131
        • Local Institution - 0129
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 111151
        • Local Institution - 0130
  • Czechia
      • Prague, Czechia, 12808
        • Local Institution - 0243
    • Brno-město
      • Brno, Brno-město, Czechia, 625 00
        • Local Institution - 0105
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Czechia, 500 05
        • Local Institution - 0104
    • Olomoucký kraj
      • Olomouc, Olomoucký kraj, Czechia, 779 00
        • Local Institution - 0102
    • Plzeň Region
      • Pilsen, Plzeň Region, Czechia, 305 99
        • Local Institution - 0120
    • Praha 10
      • Prague, Praha 10, Czechia, 100 34
        • Local Institution - 0103
  • Denmark
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Local Institution - 0285
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Local Institution - 0284
  • Finland
      • Helsinki, Finland, 00029
        • Local Institution - 0280
    • North Ostrobothnia
      • Oulu, North Ostrobothnia, Finland, 90220
        • Local Institution - 0281
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70210
        • Local Institution - 0283
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20521
        • Local Institution - 0282
  • France
      • Bayonne, France, 64109
        • Local Institution - 0244
      • Caen, France, 14033
        • Local Institution - 0315
      • Paris, France, 75010
        • Local Institution - 0077
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Local Institution - 0083
    • Alsace
      • Strasbourg, Alsace, France, 67033
        • Local Institution - 0084
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Local Institution - 0090
      • Pessac, Aquitaine, France, 33600
        • Local Institution - 0324
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13273
        • Local Institution - 0087
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21000
        • Local Institution - 0292
    • Doubs
      • Besançon, Doubs, France, 25000
        • Local Institution - 0486
    • Finistère
      • Brest, Finistère, France, 29200
        • Local Institution - 0332
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59020
        • Local Institution - 0202
    • Hauts-de-Seine
      • Saint-Cloud, Hauts-de-Seine, France, 92210
        • Local Institution - 0335
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37032
        • Local Institution - 0079
    • Isère
      • La Tronche, Isère, France, 38700
        • Local Institution - 0223
    • La Réunion
      • Saint-Pierre, La Réunion, France, 97448
        • Local Institution - 0323
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • Local Institution - 0074
    • Nord
      • Lille, Nord, France, 59000
        • Local Institution - 0081
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44000
        • Local Institution - 0325
      • Saint Priest En Jarez, Pays de la Loire Region, France, 42271
        • Local Institution - 0321
    • Rhône
      • Pierre-Bénite, Rhône, France, 69310
        • Local Institution - 0089
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • Local Institution - 0200
      • Villejuif, Val-de-Marne, France, 94800
        • Local Institution - 0076
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Local Institution - 0306
  • Germany
      • Berlin, Germany, 10967
        • Local Institution - 0508
      • Cottbus, Germany, 03048
        • Local Institution - 0503
      • Dresden, Germany, 01307
        • Local Institution - 0510
      • Essen, Germany, 45122
        • Local Institution - 0370
    • Baden-Wurttemberg
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Local Institution - 0511
    • Bavaria
      • Augsburg, Bavaria, Germany, 86156
        • Local Institution - 0383
      • Bayreuth, Bavaria, Germany, 95445
        • Local Institution - 0512
      • Erlangen, Bavaria, Germany, 91054
        • Local Institution - 0505
    • Hesse
      • Langen, Hesse, Germany, 63225
        • Local Institution - 0507
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30459
        • Local Institution - 0513
    • Rhineland-Palatinate
      • Koblenz, Rhineland-Palatinate, Germany, 56068
        • Local Institution - 0384
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Local Institution - 0504
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Local Institution - 0506
  • Greece
    • Anatolikí Makedonía Kai Thráki
      • Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece, 681 00
        • Local Institution - 0398
    • Attikí
      • Athens, Attikí, Greece, 106 76
        • Local Institution - 0399
      • Athens, Attikí, Greece, 11527
        • Local Institution - 0396
      • Chaïdári, Attikí, Greece, 12462
        • Local Institution - 0397
    • Ípeiros
      • Ioannina, Ípeiros, Greece, 455 00
        • Local Institution - 0395
  • Hungary
      • Budapest, Hungary, 1088
        • Local Institution - 0163
      • Budapest, Hungary, 1122
        • Local Institution - 0160
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Local Institution - 0266
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Local Institution - 0162
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Local Institution - 0353
    • Vas County
      • Szombathely, Vas County, Hungary, 9700
        • Local Institution - 0161
  • India
    • Karnataka
      • Belagavi, Karnataka, India, 590010
        • Local Institution - 0411
    • Kerala
      • Kochi, Kerala, India, 682027
        • Local Institution - 0430
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Local Institution - 0154
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Local Institution - 0433
      • New Delhi, National Capital Territory of Delhi, India, 110085
        • Local Institution - 0469
    • West Bengal
      • Howrah, West Bengal, India, 711103
        • Local Institution - 0413
      • New Town, West Bengal, India, 700160
        • Local Institution - 0410
  • Italy
      • Novara, Italy, 28100
        • Local Institution - 0496
    • Emilia-Romagna
      • Ravenna, Emilia-Romagna, Italy, 48121
        • Local Institution - 0495
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Local Institution - 0493
    • Sicily
      • Palermo, Sicily, Italy, 90146
        • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
  • Japan
      • Fukuoka, Japan, 810-8563
        • Local Institution - 0348
      • Fukuoka, Japan, 811-1395
        • Local Institution - 0319
      • Fukuoka, Japan, 812-8582
        • Local Institution - 0313
      • Hiroshima, Japan, 7348551
        • Local Institution - 0272
      • Kumamoto, Japan, 860-0008
        • Local Institution - 0171
      • Kyoto, Japan, 602-8566
        • Local Institution - 0215
      • Okayama, Japan, 700-8558
        • Local Institution - 0329
      • Osaka, Japan, 543-8555
        • Local Institution - 0322
      • Osaka, Japan, 545-8586
        • Local Institution - 0347
      • Yamagata, Japan, 990-9585
        • Local Institution - 0167
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Local Institution - 0371
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Local Institution - 0168
    • Fukui
      • Eiheiji-cho,Yoshida-gun, Fukui, Japan, 910-1193
        • Local Institution - 0475
    • Gifu
      • Ōgaki, Gifu, Japan, 503-8502
        • Local Institution - 0271
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608648
        • Local Institution - 0368
      • Sapporo, Hokkaido, Japan, 064-0804
        • Local Institution - 0327
    • Hyōgo
      • Amagasaki, Hyōgo, Japan, 660-8550
        • Local Institution - 0273
      • Himeji, Hyōgo, Japan, 670-8540
        • Local Institution - 0328
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8530
        • Local Institution - 0270
    • Iwate
      • Morioka, Iwate, Japan, 020-0066
        • Local Institution - 0343
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Local Institution - 0170
      • Yokohama, Kanagawa, Japan, 221-0855
        • Local Institution - 0333
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Local Institution - 0320
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Local Institution - 0166
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Local Institution - 0269
    • Shizuoka
      • Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777
        • Local Institution - 0288
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Local Institution - 0350
      • Itabashiku, Tokyo, Japan, 173-8610
        • Local Institution - 0268
    • Yamanashi
      • Chūō, Yamanashi, Japan, 409-3898
        • Local Institution - 0331
  • Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Local Institution - 0453
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
        • Local Institution - 0432
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Local Institution - 0431
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
        • Local Institution - 0449
  • Mexico
      • Puebla City, Mexico, 72424
        • Local Institution - 0124
    • DIF
      • Mexico City, DIF, Mexico, 03100
        • Local Institution - 0122
      • Mexico City, DIF, Mexico, 14080
        • Local Institution - 0121
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06720
        • Local Institution - 0128
      • Mexico City, Mexico City, Mexico, 14080
        • Local Institution - 0126
    • Michoacán
      • Morelia, Michoacán, Mexico, 58260
        • Local Institution - 0127
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66460
        • Local Institution - 0139
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Local Institution - 0125
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Local Institution - 0499
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Local Institution - 0500
  • New Zealand
      • Auckland, New Zealand, 1023
        • Local Institution - 0462
    • Otago
      • Dunedin, Otago, New Zealand, 9016
        • Local Institution - 0367
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3240
        • Local Institution - 0366
  • Norway
      • Oslo, Norway, 0310
        • Local Institution - 0391
  • Poland
    • Greater Poland Voivodeship
      • Skórzewo, Greater Poland Voivodeship, Poland, 60-185
        • Local Institution - 0388
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
        • Local Institution - 0336
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Local Institution - 0201
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-090
        • Local Institution - 0337
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Local Institution - 0443
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-027
        • Local Institution - 0330
  • Portugal
      • Lisbon, Portugal, 1500-650
        • Local Institution - 0286
      • Porto, Portugal, 4200-072
        • Local Institution - 0098
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Local Institution - 0372
  • Romania
      • Brasov, Romania, 500052
        • Local Institution - 0380
      • Bucharest, Romania, 022328
        • Local Institution - 0374
      • Bucharest, Romania, 030171
        • Local Institution - 0377
      • Bucharest, Romania, 030171
        • Local Institution - 0382
      • Bucharest, Romania, 050098
        • Local Institution - 0378
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0423
      • Iași, Romania, 700483
        • Local Institution - 0379
      • Sibiu, Romania, 557260
        • Local Institution - 0376
    • București
      • Bucharest, București, Romania, 022328
        • Local Institution - 0381
    • Mureș County
      • Tg.Mures, Mureș County, Romania, 540136
        • Local Institution - 0417
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 22384
        • Local Institution - 0438
      • Riyadh, Saudi Arabia, 12713
        • Local Institution - 0416
    • Eastern Province
      • Dammam, Eastern Province, Saudi Arabia, 31444
        • Local Institution - 0439
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi Arabia, 11426
        • Local Institution - 0445
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Local Institution - 0427
  • Slovakia
      • Bratislava, Slovakia, 83101
        • Local Institution - 0204
  • South Korea
      • Seoul, South Korea, 07345
        • Local Institution - 0118
    • Kyǒnggi-do
      • Goyang-si, Kyǒnggi-do, South Korea, 10408
        • Local Institution - 0149
      • Seongnam, Kyǒnggi-do, South Korea, 13620
        • Local Institution - 0456
      • Suwon, Kyǒnggi-do, South Korea, 16499
        • Local Institution - 0233
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, South Korea, 49201
        • Local Institution - 0115
      • Busan, Pusan-Kwangyǒkshi, South Korea, 49241
        • Local Institution - 0114
      • Busan, Pusan-Kwangyǒkshi, South Korea, 49267
        • Local Institution - 0131
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 02841
        • Local Institution - 0143
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
        • Local Institution - 0069
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Local Institution - 0100
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Local Institution - 0068
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06591
        • Local Institution - 0070
    • Taegu-Kwangyǒkshi
      • Deagu, Taegu-Kwangyǒkshi, South Korea, 41404
        • Local Institution - 0441
  • Spain
      • Cáceres, Spain, 10003
        • Local Institution - 0095
      • Madrid, Spain, 28006
        • Local Institution - 0072
      • Madrid, Spain, 28007
        • Local Institution - 0490
      • Madrid, Spain, 28040
        • Local Institution - 0488
      • Salamanca, Spain, 37007
        • Local Institution - 0093
      • Seville, Spain, 41013
        • Local Institution - 0489
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • Local Institution - 0412
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Local Institution - 0491
      • L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain, 08908
        • Local Institution - 0071
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Local Institution - 0389
    • Canary Islands
      • Santa Cruz de Tenerife, Canary Islands, Spain, 38010
        • Local Institution - 0172
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
        • Local Institution - 0314
    • Madrid, Comunidad de
      • Majadahonda, Madrid, Comunidad de, Spain, 28222
        • Local Institution - 0096
    • Murcia, Región de
      • El Palmar, Murcia, Murcia, Región de, Spain, 30120
        • Local Institution - 0409
    • Málaga
      • Málaga, Málaga, Spain, 29010
        • Local Institution - 0092
  • Sweden
    • Skåne Län [se-12]
      • Lund, Skåne Län [se-12], Sweden, 22185
        • Local Institution - 0279
    • Stockholms Län [se-01]
      • Solna, Stockholms Län [se-01], Sweden, 171 64
        • Local Institution - 0487
    • Uppsala Län [se-03]
      • Uppsala, Uppsala Län [se-03], Sweden, 751 85
        • Local Institution - 0277
    • Östergötlands Län [se-05]
      • Linköping, Östergötlands Län [se-05], Sweden, 581 85
        • Local Institution - 0278
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Local Institution - 0159
      • Taichung, Taiwan, 40447
        • Local Institution - 0135
      • Taichung, Taiwan, 407
        • Local Institution - 0145
      • Taipei, Taiwan, 10002
        • Local Institution - 0134
      • Taipei, Taiwan, 112
        • Local Institution - 0147
      • Taipei, Taiwan, 11217
        • Local Institution - 0514
      • Taoyuan District, Taiwan, 333
        • Local Institution - 0158
    • Chiayi
      • Chiayi City, Chiayi, Taiwan, 613
        • Local Institution - 0142
    • Tainan
      • Tainan, Tainan, Taiwan, 71004
        • Local Institution - 0146
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Local Institution - 0428
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital
      • Bangkok, Bangkok, Thailand, 10330
        • Local Institution - 0434
      • Bangkok, Bangkok, Thailand, 10400
        • Ramathibodi Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Local Institution - 0400
      • Ankara, Turkey (Türkiye), 06100
        • Local Institution - 0405
      • Ankara, Turkey (Türkiye), 06170
        • Local Institution - 0422
      • Ankara, Turkey (Türkiye), 06200
        • Local Institution - 0401
      • Izmir, Turkey (Türkiye), 35100
        • Local Institution - 0406
      • Mersin, Turkey (Türkiye), 33440
        • Local Institution - 0403
      • Samsun, Turkey (Türkiye), 55270
        • Local Institution - 0407
      • Trabzon, Turkey (Türkiye), 61080
        • Local Institution - 0402
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Local Institution - 0014
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Local Institution - 0477
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Local Institution - 0452
    • California
      • San Francisco, California, United States, 94143
        • Local Institution - 0342
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Local Institution - 0497
      • Jacksonville, Florida, United States, 32224
        • Local Institution - 0287
      • Margate, Florida, United States, 33063
        • Local Institution - 0415
      • Miami Beach, Florida, United States, 33140
        • Local Institution - 0045
      • Pensacola, Florida, United States, 32504
        • Local Institution - 0012
      • St. Petersburg, Florida, United States, 33705
        • Local Institution - 0502
      • Tampa, Florida, United States, 33612
        • Local Institution - 0414
      • West Palm Beach, Florida, United States, 33401
        • Local Institution - 0192
      • Weston, Florida, United States, 33331
        • Local Institution - 0485
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0303
      • Atlanta, Georgia, United States, 30303
        • Local Institution - 0515
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Local Institution - 0182
      • Skokie, Illinois, United States, 60077
        • Local Institution - 0048
    • Iowa
      • Waukee, Iowa, United States, 50309
        • Local Institution - 0461
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Local Institution - 0031
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Local Institution - 0436
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Local Institution - 0408
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 0478
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Local Institution - 0067
      • Rochester, Minnesota, United States, 55905
        • Local Institution - 0203
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Local Institution - 0437
    • Nevada
      • Reno, Nevada, United States, 89511
        • Local Institution - 0466
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Local Institution - 0498
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0480
      • Morristown, New Jersey, United States, 07960
        • Local Institution - 0049
      • New Brunswick, New Jersey, United States, 08901
        • Local Institution - 0175
    • New York
      • Buffalo, New York, United States, 14263
        • Local Institution - 0190
      • East Syracuse, New York, United States, 13057
        • Local Institution - 0451
      • New York, New York, United States, 10028
        • Local Institution - 0369
      • New York, New York, United States, 10029
        • Local Institution - 0176
      • New York, New York, United States, 10016
        • Local Institution - 0484
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Local Institution - 0174
    • Ohio
      • Massillon, Ohio, United States, 44646
        • Local Institution - 0066
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Local Institution - 0450
    • Oregon
      • Portland, Oregon, United States, 97239
        • Local Institution - 0179
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0009
      • York, Pennsylvania, United States, 17403
        • Local Institution - 0419
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Local Institution - 0435
      • Houston, Texas, United States, 77030
        • Local Institution - 0046
      • Houston, Texas, United States, 77030
        • Local Institution - 0424
      • Houston, Texas, United States, 77026
        • Local Institution - 0516
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Local Institution - 0293

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:

i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal center B-cell (GCB) and activated B-cell (ABC) types]

ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)

iii) High-grade B-cell lymphoma, not otherwise specified

iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)

v) Epstein-Barr virus + DLBCL

  • International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) > 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3.
  • Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
  • Must have Ann Arbor Stage II-IV disease.

Exclusion Criteria

  • Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
  • Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
  • Documented or suspected central nervous system (CNS) involvement by lymphoma.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)
Drug: Rituximab
Specified dose on specified days
Drug: Prednisone
Specified dose on specified days
Drug: Cyclophosphamide
Specified dose on specified days
Drug: Doxorubicin
Specified dose on specified days
Drug: Vincristine
Specified dose on specified days
Drug: Golcadomide
Specified dose on specified days
Other Names:
  • BMS-986369
  • CC-99282
Placebo Comparator: Placebo + R-CHOP
Drug: Placebo
Specified dose on specified days
Drug: Rituximab
Specified dose on specified days
Drug: Prednisone
Specified dose on specified days
Drug: Cyclophosphamide
Specified dose on specified days
Drug: Doxorubicin
Specified dose on specified days
Drug: Vincristine
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS) assessed by the Investigator
Time Frame: Up to approximately 67 months
Up to approximately 67 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 67 months
Up to approximately 67 months
Event-free survival (EFS)
Time Frame: Up to approximately 67 months
Up to approximately 67 months
Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC)
Time Frame: Up to approximately 18 weeks
Up to approximately 18 weeks
Minimal residual disease (MRD) negativity rate
Time Frame: Up to approximately 18 weeks
Up to approximately 18 weeks
Progression-free survival (PFS) assessed by the IRAC
Time Frame: Up to approximately 47 months
Up to approximately 47 months
Objective response (OR) assessed by the Investigator
Time Frame: Up to approximately 18 weeks
Up to approximately 18 weeks
Complete metabolic response (CMR) assessed by the Investigator
Time Frame: Up to approximately 18 weeks
Up to approximately 18 weeks
PFS24 assessed by the Investigator 24 months after randomization
Time Frame: Up to 24 months
Up to 24 months
Duration of response (DoR)
Time Frame: Up to approximately 67 months
Up to approximately 67 months
Second progression-free survival (PFS2) assessed by the Investigator
Time Frame: Up to approximately 67 months
Up to approximately 67 months
Relative dose intensity (%)
Time Frame: Up to 18 weeks
Up to 18 weeks
Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire
Time Frame: Up to approximately 67 months
Up to approximately 67 months
Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire
Time Frame: Up to approximately 67 months
Up to approximately 67 months
Mean change from baseline in the EORTC QLQ-C30
Time Frame: Up to approximately 67 months
Up to approximately 67 months
Mean change from baseline in the FACT-LymS
Time Frame: Up to approximately 67 months
Up to approximately 67 months
Number of participants with Adverse Events (AEs)
Time Frame: Up to approximately 20 weeks
Up to approximately 20 weeks
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to approximately 20 weeks
Up to approximately 20 weeks
Number of participants with laboratory abnormalities
Time Frame: Up to approximately 20 weeks
Up to approximately 20 weeks
Number of participants with vital sign abnormalities
Time Frame: Up to approximately 20 weeks
Up to approximately 20 weeks
PFS assessed by the Investigator
Time Frame: Up to approximately 67 months
Up to approximately 67 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2024

Primary Completion (Estimated)

August 14, 2028

Study Completion (Estimated)

November 20, 2029

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA073-1020
  • 2023-510178-15 (Registry Identifier: EU CT Number)
  • U1111-1300-8493 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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