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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
Sponsor: Celgene
Summary
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).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
850
Start Date
2024-06-19
Completion Date
2029-11-20
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Golcadomide
Specified dose on specified days
Placebo
Specified dose on specified days
Rituximab
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Doxorubicin
Specified dose on specified days
Vincristine
Specified dose on specified days
Prednisone
Specified dose on specified days
Locations (325)
Local Institution - 0014
Mobile, Alabama, United States
Local Institution - 0477
Anchorage, Alaska, United States
Local Institution - 0452
Phoenix, Arizona, United States
Local Institution - 0342
San Francisco, California, United States
Local Institution - 0497
Fort Myers, Florida, United States
Local Institution - 0287
Jacksonville, Florida, United States
Local Institution - 0415
Margate, Florida, United States
Local Institution - 0045
Miami Beach, Florida, United States
Local Institution - 0012
Pensacola, Florida, United States
Local Institution - 0502
St. Petersburg, Florida, United States
Local Institution - 0414
Tampa, Florida, United States
Local Institution - 0192
West Palm Beach, Florida, United States
Local Institution - 0485
Weston, Florida, United States
Local Institution - 0515
Atlanta, Georgia, United States
Local Institution - 0303
Atlanta, Georgia, United States
Local Institution - 0182
Chicago, Illinois, United States
Local Institution - 0048
Skokie, Illinois, United States
Local Institution - 0461
Waukee, Iowa, United States
Local Institution - 0031
Westwood, Kansas, United States
Local Institution - 0436
Edgewood, Kentucky, United States
Local Institution - 0408
Baton Rouge, Louisiana, United States
Local Institution - 0478
Ann Arbor, Michigan, United States
Local Institution - 0067
Minneapolis, Minnesota, United States
Local Institution - 0203
Rochester, Minnesota, United States
Local Institution - 0437
Kansas City, Missouri, United States
Local Institution - 0466
Reno, Nevada, United States
Local Institution - 0498
East Brunswick, New Jersey, United States
Local Institution - 0480
Hackensack, New Jersey, United States
Local Institution - 0049
Morristown, New Jersey, United States
Local Institution - 0175
New Brunswick, New Jersey, United States
Local Institution - 0190
Buffalo, New York, United States
Local Institution - 0451
East Syracuse, New York, United States
Local Institution - 0484
New York, New York, United States
Local Institution - 0369
New York, New York, United States
Local Institution - 0176
New York, New York, United States
Local Institution - 0174
Chapel Hill, North Carolina, United States
Local Institution - 0066
Massillon, Ohio, United States
Local Institution - 0450
Tulsa, Oklahoma, United States
Local Institution - 0179
Portland, Oregon, United States
Local Institution - 0009
Pittsburgh, Pennsylvania, United States
Local Institution - 0419
York, Pennsylvania, United States
Local Institution - 0435
Fort Sam Houston, Texas, United States
Local Institution - 0516
Houston, Texas, United States
Local Institution - 0046
Houston, Texas, United States
Local Institution - 0424
Houston, Texas, United States
Local Institution - 0293
Richmond, Virginia, United States
Local Institution - 0113
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0421
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0112
Buenos Aires, Argentina
Local Institution - 0119
Buenos Aires, Argentina
Local Institution - 0136
Buenos Aires, Argentina
Local Institution - 0111
Córdoba, Argentina
Local Institution - 0357
Gosford, New South Wales, Australia
Local Institution - 0361
Sydney, New South Wales, Australia
Local Institution - 0358
Westmead, New South Wales, Australia
Local Institution - 0363
Tiwi, Northern Territory, Australia
Local Institution - 0356
Birtinya, Queensland, Australia
Local Institution - 0360
Southport, Queensland, Australia
Local Institution - 0365
Frankston, Victoria, Australia
Local Institution - 0362
Heidelberg, Victoria, Australia
Local Institution - 0359
St Albans, Victoria, Australia
Local Institution - 0364
Warrnambool, Victoria, Australia
Local Institution - 0385
Wels, Upper Austria, Austria
Local Institution - 0387
Linz, Austria
Local Institution - 0386
Vienna, Austria
Local Institution - 0255
Fortaleza, Ceará, Brazil
Local Institution - 0297
Lago Sul, Federal District, Brazil
Local Institution - 0256
Goiânia, Goiás, Brazil
Local Institution - 0302
Curitiba, Paraná, Brazil
Local Institution - 0296
Niterói, Rio de Janeiro, Brazil
Local Institution - 0304
Natal, Rio Grande do Norte, Brazil
Local Institution - 0253
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0246
Chapecó, Santa Catarina, Brazil
Local Institution - 0247
Joinville, Santa Catarina, Brazil
Local Institution - 0250
Barretos, São Paulo, Brazil
Local Institution - 0249
Jaú, São Paulo, Brazil
Local Institution - 0301
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0248
São Paulo, São Paulo, Brazil
Local Institution - 0316
São Paulo, São Paulo, Brazil
Local Institution - 0298
Rio de Janeiro, Brazil
Local Institution - 0294
São Paulo, Brazil
Local Institution - 0252
São Paulo, Brazil
Local Institution - 0317
São Paulo, Brazil
Local Institution - 0251
São Paulo, Brazil
Local Institution - 0393
Plovdiv, Bulgaria
Local Institution - 0392
Sofia, Bulgaria
Local Institution - 0394
Sofia, Bulgaria
Local Institution - 0091
Victoria, British Columbia, Canada
Local Institution - 0153
Montreal, Quebec, Canada
Local Institution - 0073
Montreal, Quebec, Canada
Local Institution - 0004
Sherbrooke, Quebec, Canada
Local Institution - 0164
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0106
Santiago, Santiago Metropolitan, Chile
Local Institution - 0107
Santiago, Santiago Metropolitan, Chile
Local Institution - 0108
Santiago, Santiago Metropolitan, Chile
Local Institution - 0110
Santiago, Santiago Metropolitan, Chile
Local Institution - 0459
Santiago, Santiago Metropolitan, Chile
Local Institution - 0195
Beijing, Beijing Municipality, China
Local Institution - 0236
Chongqing, Chongqing Municipality, China
Local Institution - 0196
Chongqing, Chongqing Municipality, China
Local Institution - 0274
Fuzhou, Fujian, China
Local Institution - 0157
Xiamen, Fujian, China
Local Institution - 0133
Guangzhou, Guangdong, China
Local Institution - 0240
Guangzhou, Guangdong, China
Local Institution - 0338
Nanning, Guangxi, China
Local Institution - 0239
Harbin, Heilongjiang, China
Local Institution - 0238
Zhengzhou, Henan, China
Local Institution - 0346
Wuhan, Hubei, China
Local Institution - 0214
Wuhan, Hubei, China
Local Institution - 0275
Changsha, Hunan, China
Local Institution - 0156
Suzhou, Jiangsu, China
Local Institution - 0237
Nanchang, Jiangxi, China
Local Institution - 0241
Nanchang, Jiangxi, China
Local Institution - 0291
Changchun, Jilin, China
Local Institution - 0334
Shenyang, Liaoning, China
Local Institution - 0169
Shenyang, Liaoning, China
Local Institution - 0242
Jinan, Shandong, China
Local Institution - 0344
Jinan, Shandong, China
Local Institution - 0132
Shanghai, Shanghai Municipality, China
Local Institution - 0339
Shanghai, Shanghai Municipality, China
Local Institution - 0234
Taiyuan, Shanxi, China
Local Institution - 0141
Chengdu, Sichuan, China
Local Institution - 0470
Tianjin, Tianjin Municipality, China
Local Institution - 0467
Ürümqi, Xinjiang, China
Local Institution - 0197
Hangzhou, Zhejiang, China
Local Institution - 0483
Hangzhou, Zhejiang, China
Local Institution - 0457
Wenzhou, Zhejiang, China
Local Institution - 0129
Bogotá, Bogota D.C., Colombia
Local Institution - 0130
Bogota, Cundinamarca, Colombia
Local Institution - 0105
Brno, Brno-město, Czechia
Local Institution - 0104
Hradec Králové, Hradec Králové, Czechia
Local Institution - 0102
Olomouc, Olomoucký kraj, Czechia
Local Institution - 0120
Pilsen, Plzeň Region, Czechia
Local Institution - 0103
Prague, Praha 10, Czechia
Local Institution - 0243
Prague, Czechia
Local Institution - 0285
Aarhus, Central Jutland, Denmark
Local Institution - 0284
Odense, Region Syddanmark, Denmark
Local Institution - 0281
Oulu, North Ostrobothnia, Finland
Local Institution - 0283
Kuopio, Northern Savonia, Finland
Local Institution - 0282
Turku, Southwest Finland, Finland
Local Institution - 0280
Helsinki, Finland
Local Institution - 0083
Nice, Alpes-Maritimes, France
Local Institution - 0084
Strasbourg, Alsace, France
Local Institution - 0090
Bordeaux, Aquitaine, France
Local Institution - 0324
Pessac, Aquitaine, France
Local Institution - 0087
Marseille, Bouches-du-Rhône, France
Local Institution - 0292
Dijon, Côte-d'Or, France
Local Institution - 0486
Besançon, Doubs, France
Local Institution - 0332
Brest, Finistère, France
Local Institution - 0202
Lille, Hauts-de-France, France
Local Institution - 0335
Saint-Cloud, Hauts-de-Seine, France
Local Institution - 0079
Tours, Indre-et-Loire, France
Local Institution - 0223
La Tronche, Isère, France
Local Institution - 0323
Saint-Pierre, La Réunion, France
Local Institution - 0074
Montpellier, Languedoc-Roussillon, France
Local Institution - 0081
Lille, Nord, France
Local Institution - 0325
Nantes, Pays de la Loire Region, France
Local Institution - 0321
Saint Priest En Jarez, Pays de la Loire Region, France
Local Institution - 0089
Pierre-Bénite, Rhône, France
Local Institution - 0200
Créteil, Val-de-Marne, France
Local Institution - 0076
Villejuif, Val-de-Marne, France
Local Institution - 0306
Poitiers, Vienne, France
Local Institution - 0244
Bayonne, France
Local Institution - 0315
Caen, France
Local Institution - 0077
Paris, France
Local Institution - 0511
Ulm, Baden-Wurttemberg, Germany
Local Institution - 0383
Augsburg, Bavaria, Germany
Local Institution - 0512
Bayreuth, Bavaria, Germany
Local Institution - 0505
Erlangen, Bavaria, Germany
Local Institution - 0507
Langen, Hesse, Germany
Local Institution - 0513
Hanover, Lower Saxony, Germany
Local Institution - 0384
Koblenz, Rhineland-Palatinate, Germany
Local Institution - 0504
Halle, Saxony-Anhalt, Germany
Local Institution - 0506
Lübeck, Schleswig-Holstein, Germany
Local Institution - 0508
Berlin, Germany
Local Institution - 0503
Cottbus, Germany
Local Institution - 0510
Dresden, Germany
Local Institution - 0370
Essen, Germany
Local Institution - 0398
Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece
Local Institution - 0399
Athens, Attikí, Greece
Local Institution - 0396
Athens, Attikí, Greece
Local Institution - 0397
Chaïdári, Attikí, Greece
Local Institution - 0395
Ioannina, Ípeiros, Greece
Local Institution - 0266
Debrecen, Hajdú-Bihar, Hungary
Local Institution - 0162
Kaposvár, Somogy County, Hungary
Local Institution - 0353
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Local Institution - 0161
Szombathely, Vas County, Hungary
Local Institution - 0163
Budapest, Hungary
Local Institution - 0160
Budapest, Hungary
Local Institution - 0411
Belagavi, Karnataka, India
Local Institution - 0430
Kochi, Kerala, India
Local Institution - 0154
Mumbai, Maharashtra, India
Local Institution - 0433
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0469
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0413
Howrah, West Bengal, India
Local Institution - 0410
New Town, West Bengal, India
Local Institution - 0495
Ravenna, Emilia-Romagna, Italy
Local Institution - 0493
Rome, Lazio, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO
Palermo, Sicily, Italy
Local Institution - 0496
Novara, Italy
Local Institution - 0371
Nagoya, Aichi-ken, Japan
Local Institution - 0168
Kashiwa, Chiba, Japan
Local Institution - 0475
Eiheiji-cho,Yoshida-gun, Fukui, Japan
Local Institution - 0271
Ōgaki, Gifu, Japan
Local Institution - 0368
Sapporo, Hokkaido, Japan
Local Institution - 0327
Sapporo, Hokkaido, Japan
Local Institution - 0273
Amagasaki, Hyōgo, Japan
Local Institution - 0328
Himeji, Hyōgo, Japan
Local Institution - 0270
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0343
Morioka, Iwate, Japan
Local Institution - 0170
Isehara, Kanagawa, Japan
Local Institution - 0333
Yokohama, Kanagawa, Japan
Local Institution - 0320
Sendai, Miyagi, Japan
Local Institution - 0166
Sakai, Osaka, Japan
Local Institution - 0269
Hidaka, Saitama, Japan
Local Institution - 0288
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
Local Institution - 0350
Bunkyo-ku, Tokyo, Japan
Local Institution - 0268
Itabashiku, Tokyo, Japan
Local Institution - 0331
Chūō, Yamanashi, Japan
Local Institution - 0348
Fukuoka, Japan
Local Institution - 0319
Fukuoka, Japan
Local Institution - 0313
Fukuoka, Japan
Local Institution - 0272
Hiroshima, Japan
Local Institution - 0171
Kumamoto, Japan
Local Institution - 0215
Kyoto, Japan
Local Institution - 0329
Okayama, Japan
Local Institution - 0322
Osaka, Japan
Local Institution - 0347
Osaka, Japan
Local Institution - 0167
Yamagata, Japan
Local Institution - 0453
Lembah Pantai, Kuala Lumpur, Malaysia
Local Institution - 0432
George Town, Pulau Pinang, Malaysia
Local Institution - 0431
Kuching, Sarawak, Malaysia
Local Institution - 0449
Ampang, Selangor, Malaysia
Local Institution - 0122
Mexico City, DIF, Mexico
Local Institution - 0121
Mexico City, DIF, Mexico
Local Institution - 0128
Mexico City, Mexico City, Mexico
Local Institution - 0126
Mexico City, Mexico City, Mexico
Local Institution - 0127
Morelia, Michoacán, Mexico
Local Institution - 0139
Monterrey, Nuevo León, Mexico
Local Institution - 0125
Oaxaca City, Oaxaca, Mexico
Local Institution - 0124
Puebla City, Mexico
Local Institution - 0500
Leiden, South Holland, Netherlands
Local Institution - 0499
Groningen, Netherlands
Local Institution - 0367
Dunedin, Otago, New Zealand
Local Institution - 0366
Hamilton, Waikato Region, New Zealand
Local Institution - 0462
Auckland, New Zealand
Local Institution - 0391
Oslo, Norway
Local Institution - 0388
Skórzewo, Greater Poland Voivodeship, Poland
Local Institution - 0336
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 0201
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0337
Lublin, Lublin Voivodeship, Poland
Local Institution - 0443
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0330
Katowice, Silesian Voivodeship, Poland
Local Institution - 0286
Lisbon, Portugal
Local Institution - 0098
Porto, Portugal
Local Institution - 0372
San Juan, Puerto Rico
Local Institution - 0381
Bucharest, București, Romania
Local Institution - 0417
Tg.Mures, Mureș County, Romania
Local Institution - 0380
Brasov, Romania
Local Institution - 0374
Bucharest, Romania
Local Institution - 0377
Bucharest, Romania
Local Institution - 0382
Bucharest, Romania
Local Institution - 0378
Bucharest, Romania
Local Institution - 0423
Cluj-Napoca, Romania
Local Institution - 0379
Iași, Romania
Local Institution - 0376
Sibiu, Romania
Local Institution - 0439
Dammam, Eastern Province, Saudi Arabia
Local Institution - 0445
Riyadh, Riyadh Region, Saudi Arabia
Local Institution - 0438
Jeddah, Saudi Arabia
Local Institution - 0416
Riyadh, Saudi Arabia
Local Institution - 0427
Singapore, Central Singapore, Singapore
Local Institution - 0204
Bratislava, Slovakia
Local Institution - 0149
Goyang-si, Kyǒnggi-do, South Korea
Local Institution - 0456
Seongnam, Kyǒnggi-do, South Korea
Local Institution - 0233
Suwon, Kyǒnggi-do, South Korea
Local Institution - 0115
Busan, Pusan-Kwangyǒkshi, South Korea
Local Institution - 0114
Busan, Pusan-Kwangyǒkshi, South Korea
Local Institution - 0131
Busan, Pusan-Kwangyǒkshi, South Korea
Local Institution - 0143
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0069
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0100
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0068
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0070
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0441
Deagu, Taegu-Kwangyǒkshi, South Korea
Local Institution - 0118
Seoul, South Korea
Local Institution - 0412
A Coruña, A Coruña [La Coruña], Spain
Local Institution - 0491
Badalona, Barcelona [Barcelona], Spain
Local Institution - 0071
L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain
Local Institution - 0389
Barakaldo, Bizkaia, Spain
Local Institution - 0172
Santa Cruz de Tenerife, Canary Islands, Spain
Local Institution - 0314
Donostia / San Sebastian, Gipuzkoa, Spain
Local Institution - 0096
Majadahonda, Madrid, Comunidad de, Spain
Local Institution - 0409
El Palmar, Murcia, Murcia, Región de, Spain
Local Institution - 0092
Málaga, Málaga, Spain
Local Institution - 0095
Cáceres, Spain
Local Institution - 0072
Madrid, Spain
Local Institution - 0490
Madrid, Spain
Local Institution - 0488
Madrid, Spain
Local Institution - 0093
Salamanca, Spain
Local Institution - 0489
Seville, Spain
Local Institution - 0279
Lund, Skåne Län [se-12], Sweden
Local Institution - 0487
Solna, Stockholms Län [se-01], Sweden
Local Institution - 0277
Uppsala, Uppsala Län [se-03], Sweden
Local Institution - 0278
Linköping, Östergötlands Län [se-05], Sweden
Local Institution - 0142
Chiayi City, Chiayi, Taiwan
Local Institution - 0146
Tainan, Tainan, Taiwan
Local Institution - 0159
Kaohsiung City, Taiwan
Local Institution - 0135
Taichung, Taiwan
Local Institution - 0145
Taichung, Taiwan
Local Institution - 0134
Taipei, Taiwan
Local Institution - 0514
Taipei, Taiwan
Local Institution - 0147
Taipei, Taiwan
Local Institution - 0158
Taoyuan District, Taiwan
Local Institution - 0434
Bangkok, Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital
Bangkok, Bangkok, Thailand
Local Institution - 0428
Chiang Mai, Thailand
Local Institution - 0400
Ankara, Turkey (Türkiye)
Local Institution - 0405
Ankara, Turkey (Türkiye)
Local Institution - 0422
Ankara, Turkey (Türkiye)
Local Institution - 0401
Ankara, Turkey (Türkiye)
Local Institution - 0406
Izmir, Turkey (Türkiye)
Local Institution - 0403
Mersin, Turkey (Türkiye)
Local Institution - 0407
Samsun, Turkey (Türkiye)
Local Institution - 0402
Trabzon, Turkey (Türkiye)