AzTrials
AzTrials

Large B-cell LymphomaPhase 3GOLSEEK-1NCT06356129

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

A Phase 3 study testing Golcadomide, Rituximab and Cyclophosphamide in people with Large B-cell Lymphoma, run by Celgene at 325 sites in 38 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Large B-cell Lymphoma
What is being tested?
Golcadomide, Rituximab and Cyclophosphamide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
850 participants
Where
325 sitesin 38 countries
Study dates
19 Jun 2024to 26 Jun 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal center B-cell (GCB) and activated B-cell (ABC) types]
  • High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)
  • High-grade B-cell lymphoma, not otherwise specified
  • T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)
  • Epstein-Barr virus + DLBCL
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

325 sites in 38 countries.

325 sites in 38 countries

United States46 sites

  • Local Institution - 0477

    Anchorage, Alaska, 99508

  • Local Institution - 0478

    Ann Arbor, Michigan, 48109

  • Local Institution - 0515

    Atlanta, Georgia, 30303

  • Local Institution - 0303

    Atlanta, Georgia, 30322

  • Local Institution - 0408

    Baton Rouge, Louisiana, 70809

  • Local Institution - 0190

    Buffalo, New York, 14263

  • Local Institution - 0174

    Chapel Hill, North Carolina, 27599

  • Local Institution - 0182

    Chicago, Illinois, 60611

  • Local Institution - 0498

    East Brunswick, New Jersey, 08816

  • Local Institution - 0451

    East Syracuse, New York, 13057

  • Local Institution - 0436

    Edgewood, Kentucky, 41017

  • Local Institution - 0497

    Fort Myers, Florida, 33901

  • Local Institution - 0435

    Fort Sam Houston, Texas, 78234

  • Local Institution - 0480

    Hackensack, New Jersey, 07601

  • Local Institution - 0516

    Houston, Texas, 77026

  • Local Institution - 0046

    Houston, Texas, 77030

  • Local Institution - 0424

    Houston, Texas, 77030

  • Local Institution - 0287

    Jacksonville, Florida, 32224

  • Local Institution - 0437

    Kansas City, Missouri, 64132

  • Local Institution - 0415

    Margate, Florida, 33063

  • Local Institution - 0066

    Massillon, Ohio, 44646

  • Local Institution - 0045

    Miami Beach, Florida, 33140

  • Local Institution - 0067

    Minneapolis, Minnesota, 55407

  • Local Institution - 0014

    Mobile, Alabama, 36604

  • Local Institution - 0049

    Morristown, New Jersey, 07960

  • Local Institution - 0175

    New Brunswick, New Jersey, 08901

  • Local Institution - 0484

    New York, New York, 10016

  • Local Institution - 0369

    New York, New York, 10028

  • Local Institution - 0176

    New York, New York, 10029

  • Local Institution - 0012

    Pensacola, Florida, 32504

  • Local Institution - 0452

    Phoenix, Arizona, 85054

  • Local Institution - 0009

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 0179

    Portland, Oregon, 97239

  • Local Institution - 0466

    Reno, Nevada, 89511

  • Local Institution - 0293

    Richmond, Virginia, 23298

  • Local Institution - 0203

    Rochester, Minnesota, 55905

  • Local Institution - 0342

    San Francisco, California, 94143

  • Local Institution - 0048

    Skokie, Illinois, 60077

  • Local Institution - 0502

    St. Petersburg, Florida, 33705

  • Local Institution - 0414

    Tampa, Florida, 33612

  • Local Institution - 0450

    Tulsa, Oklahoma, 74146

  • Local Institution - 0461

    Waukee, Iowa, 50309

  • Local Institution - 0192

    West Palm Beach, Florida, 33401

  • Local Institution - 0485

    Weston, Florida, 33331

  • Local Institution - 0031

    Westwood, Kansas, 66205

  • Local Institution - 0419

    York, Pennsylvania, 17403

Other trials in United States

China30 sites

  • Local Institution - 0195

    Beijing, Beijing Municipality, 100091

  • Local Institution - 0291

    Changchun, Jilin, 130021

  • Local Institution - 0275

    Changsha, Hunan, 410013

  • Local Institution - 0141

    Chengdu, Sichuan, 610041

  • Local Institution - 0236

    Chongqing, Chongqing Municipality, 400016

  • Local Institution - 0196

    Chongqing, Chongqing Municipality, 400030

  • Local Institution - 0274

    Fuzhou, Fujian, 350014

  • Local Institution - 0133

    Guangzhou, Guangdong, 510515

  • Local Institution - 0240

    Guangzhou, Guangdong, 510555

  • Local Institution - 0197

    Hangzhou, Zhejiang, 310003

  • Local Institution - 0483

    Hangzhou, Zhejiang, 310052

  • Local Institution - 0239

    Harbin, Heilongjiang, 150081

  • Local Institution - 0242

    Jinan, Shandong, 250012

  • Local Institution - 0344

    Jinan, Shandong, 250117

  • Local Institution - 0237

    Nanchang, Jiangxi, 330006

  • Local Institution - 0241

    Nanchang, Jiangxi, 330029

  • Local Institution - 0338

    Nanning, Guangxi, 530021

  • Local Institution - 0132

    Shanghai, Shanghai Municipality, 200025

  • Local Institution - 0339

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0334

    Shenyang, Liaoning, 110004

  • Local Institution - 0169

    Shenyang, Liaoning, 110015

  • Local Institution - 0156

    Suzhou, Jiangsu, 215006

  • Local Institution - 0234

    Taiyuan, Shanxi, 030032

  • Local Institution - 0470

    Tianjin, Tianjin Municipality, 300060

  • Local Institution - 0467

    Ürümqi, Xinjiang, 830000

  • Local Institution - 0457

    Wenzhou, Zhejiang, 325000

  • Local Institution - 0346

    Wuhan, Hubei, 430022

  • Local Institution - 0214

    Wuhan, Hubei, 430030

  • Local Institution - 0157

    Xiamen, Fujian, 361003

  • Local Institution - 0238

    Zhengzhou, Henan, 450008

Other trials in China

Japan29 sites

  • Local Institution - 0273

    Amagasaki, Hyōgo, 660-8550

  • Local Institution - 0350

    Bunkyo-ku, Tokyo, 113-8431

  • Local Institution - 0331

    Chūō, Yamanashi, 409-3898

  • Local Institution - 0475

    Eiheiji-cho,Yoshida-gun, Fukui, 910-1193

  • Local Institution - 0348

    Fukuoka, 810-8563

  • Local Institution - 0319

    Fukuoka, 811-1395

  • Local Institution - 0313

    Fukuoka, 812-8582

  • Local Institution - 0269

    Hidaka, Saitama, 350-1298

  • Local Institution - 0328

    Himeji, Hyōgo, 670-8540

  • Local Institution - 0272

    Hiroshima, 7348551

  • Local Institution - 0170

    Isehara, Kanagawa, 259-1193

  • Local Institution - 0270

    Kanazawa, Ishikawa-ken, 920-8530

  • Local Institution - 0168

    Kashiwa, Chiba, 277-8577

  • Local Institution - 0171

    Kumamoto, 860-0008

  • Local Institution - 0215

    Kyoto, 602-8566

  • Local Institution - 0343

    Morioka, Iwate, 020-0066

  • Local Institution - 0288

    Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777

  • Local Institution - 0371

    Nagoya, Aichi-ken, 466-8560

  • Local Institution - 0271

    Ōgaki, Gifu, 503-8502

  • Local Institution - 0329

    Okayama, 700-8558

  • Local Institution - 0322

    Osaka, 543-8555

  • Local Institution - 0347

    Osaka, 545-8586

  • Local Institution - 0166

    Sakai, Osaka, 590-0197

  • Local Institution - 0368

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0327

    Sapporo, Hokkaido, 064-0804

  • Local Institution - 0320

    Sendai, Miyagi, 980-8574

  • Local Institution - 0268

    tabashi City, Tokyo, 173-8610

  • Local Institution - 0167

    Yamagata, 990-9585

  • Local Institution - 0333

    Yokohama, Kanagawa, 221-0855

Other trials in Japan

France24 sites

  • Local Institution - 0244

    Bayonne, 64109

  • Local Institution - 0486

    Besançon, Doubs, 25000

  • Local Institution - 0090

    Bordeaux, Aquitaine, 33076

  • Local Institution - 0332

    Brest, Finistère, 29200

  • Local Institution - 0315

    Caen, 14033

  • Local Institution - 0200

    Créteil, Val-de-Marne, 94010

  • Local Institution - 0292

    Dijon, Côte-d'Or, 21000

  • Local Institution - 0223

    La Tronche, Isère, 38700

  • Local Institution - 0202

    Lille, Hauts-de-France, 59020

  • Local Institution - 0081

    Lille, Nord, 59000

  • Local Institution - 0087

    Marseille, Bouches-du-Rhône, 13273

  • Local Institution - 0074

    Montpellier, Languedoc-Roussillon, 34295

  • Local Institution - 0325

    Nantes, Pays de la Loire Region, 44000

  • Local Institution - 0083

    Nice, Alpes-Maritimes, 06202

  • Local Institution - 0077

    Paris, 75010

  • Local Institution - 0324

    Pessac, Aquitaine, 33600

  • Local Institution - 0089

    Pierre-Bénite, Rhône, 69310

  • Local Institution - 0306

    Poitiers, Vienne, 86021

  • Local Institution - 0321

    Saint Priest En Jarez, Pays de la Loire Region, 42271

  • Local Institution - 0335

    Saint-Cloud, Hauts-de-Seine, 92210

  • Local Institution - 0323

    Saint-Pierre, La Réunion, 97448

  • Local Institution - 0084

    Strasbourg, Alsace, 67033

  • Local Institution - 0079

    Tours, Indre-et-Loire, 37032

  • Local Institution - 0076

    Villejuif, Val-de-Marne, 94800

Other trials in France

Brazil19 sites

  • Local Institution - 0250

    Barretos, São Paulo, 14784400

  • Local Institution - 0246

    Chapecó, Santa Catarina, 89812-210

  • Local Institution - 0302

    Curitiba, Paraná, 81520-060

  • Local Institution - 0255

    Fortaleza, Ceará, 60115-281

  • Local Institution - 0256

    Goiânia, Goiás, 74605-020

  • Local Institution - 0249

    Jaú, São Paulo, 17210-120

  • Local Institution - 0247

    Joinville, Santa Catarina, 89201260

  • Local Institution - 0297

    Lago Sul, Federal District, 71635580

  • Local Institution - 0304

    Natal, Rio Grande do Norte, 59075-740

  • Local Institution - 0296

    Niterói, Rio de Janeiro, 24020-096

  • Local Institution - 0253

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Local Institution - 0298

    Rio de Janeiro, 22061-080

  • Local Institution - 0301

    São José do Rio Preto, São Paulo, 15090000

  • Local Institution - 0248

    São Paulo, São Paulo, 01323-903

  • Local Institution - 0316

    São Paulo, São Paulo, 01509-010

  • Local Institution - 0294

    São Paulo, 01409-901

  • Local Institution - 0252

    São Paulo, 04543-000

  • Local Institution - 0317

    São Paulo, 05403-000

  • Local Institution - 0251

    São Paulo, 05652-900

Other trials in Brazil

Spain15 sites

  • Local Institution - 0412

    A Coruña, A Coruña [La Coruña], 15006

  • Local Institution - 0491

    Badalona, Barcelona [Barcelona], 08916

  • Local Institution - 0389

    Barakaldo, Bizkaia, 48903

  • Local Institution - 0095

    Cáceres, 10003

  • Local Institution - 0314

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Local Institution - 0409

    El Palmar, Murcia, Murcia, Región de, 30120

  • Local Institution - 0071

    L'Hospitalet Del Llobregat, Barcelona [Barcelona], 08908

  • Local Institution - 0072

    Madrid, 28006

  • Local Institution - 0490

    Madrid, 28007

  • Local Institution - 0488

    Madrid, 28040

  • Local Institution - 0096

    Majadahonda, Madrid, Comunidad de, 28222

  • Local Institution - 0092

    Málaga, Málaga, 29010

  • Local Institution - 0093

    Salamanca, 37007

  • Local Institution - 0172

    Santa Cruz de Tenerife, Canary Islands, 38010

  • Local Institution - 0489

    Seville, 41013

Other trials in Spain

Germany13 sites

  • Local Institution - 0383

    Augsburg, Bavaria, 86156

  • Local Institution - 0512

    Bayreuth, Bavaria, 95445

  • Local Institution - 0508

    Berlin, 10967

  • Local Institution - 0503

    Cottbus, 03048

  • Local Institution - 0510

    Dresden, 01307

  • Local Institution - 0505

    Erlangen, Bavaria, 91054

  • Local Institution - 0370

    Essen, 45122

  • Local Institution - 0504

    Halle, Saxony-Anhalt, 06120

  • Local Institution - 0513

    Hanover, Lower Saxony, 30459

  • Local Institution - 0384

    Koblenz, Rhineland-Palatinate, 56068

  • Local Institution - 0507

    Langen, Hesse, 63225

  • Local Institution - 0506

    Lübeck, Schleswig-Holstein, 23538

  • Local Institution - 0511

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

South Korea13 sites

  • Local Institution - 0115

    Busan, Pusan-Kwangyǒkshi, 49201

  • Local Institution - 0114

    Busan, Pusan-Kwangyǒkshi, 49241

  • Local Institution - 0131

    Busan, Pusan-Kwangyǒkshi, 49267

  • Local Institution - 0441

    Deagu, Taegu-Kwangyǒkshi, 41404

  • Local Institution - 0149

    Goyang-si, Kyǒnggi-do, 10408

  • Local Institution - 0456

    Seongnam, Kyǒnggi-do, 13620

  • Local Institution - 0143

    Seoul, Seoul-teukbyeolsi [Seoul], 02841

  • Local Institution - 0069

    Seoul, Seoul-teukbyeolsi [Seoul], 03080

  • Local Institution - 0100

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Local Institution - 0068

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

  • Local Institution - 0070

    Seoul, Seoul-teukbyeolsi [Seoul], 06591

  • Local Institution - 0118

    Seoul, 07345

  • Local Institution - 0233

    Suwon, Kyǒnggi-do, 16499

Other trials in South Korea

Australia10 sites

  • Local Institution - 0356

    Birtinya, Queensland, 4575

  • Local Institution - 0365

    Frankston, Victoria, 3195

  • Local Institution - 0357

    Gosford, New South Wales, 2250

  • Local Institution - 0362

    Heidelberg, Victoria, 3084

  • Local Institution - 0360

    Southport, Queensland, 4215

  • Local Institution - 0359

    St Albans, Victoria, 3021

  • Local Institution - 0361

    Sydney, New South Wales, 2560

  • Local Institution - 0363

    Tiwi, Northern Territory, 0810

  • Local Institution - 0364

    Warrnambool, Victoria, 3280

  • Local Institution - 0358

    Westmead, New South Wales, 2145

Other trials in Australia

Romania10 sites

  • Local Institution - 0380

    Brasov, 500052

  • Local Institution - 0381

    Bucharest, Bucharest, 022328

  • Local Institution - 0374

    Bucharest, 022328

  • Local Institution - 0377

    Bucharest, 030171

  • Local Institution - 0382

    Bucharest, 030171

  • Local Institution - 0378

    Bucharest, 050098

  • Local Institution - 0423

    Cluj-Napoca, 400015

  • Local Institution - 0379

    Iași, 700483

  • Local Institution - 0376

    Sibiu, 557260

  • Local Institution - 0417

    Tg.Mures, Mureș County, 540136

Other trials in Romania

Taiwan9 sites

  • Local Institution - 0142

    Chiayi City, Chiayi, 613

  • Local Institution - 0159

    Kaohsiung City, 83301

  • Local Institution - 0135

    Taichung, 40447

  • Local Institution - 0145

    Taichung, 407

  • Local Institution - 0146

    Tainan, Tainan, 71004

  • Local Institution - 0134

    Taipei, 10002

  • Local Institution - 0514

    Taipei, 11217

  • Local Institution - 0147

    Taipei, 112

  • Local Institution - 0158

    Taoyuan, 333

Other trials in Taiwan

Mexico8 sites

  • Local Institution - 0122

    Mexico City, DIF, 03100

  • Local Institution - 0121

    Mexico City, DIF, 14080

  • Local Institution - 0128

    Mexico City, Mexico City, 06720

  • Local Institution - 0126

    Mexico City, Mexico City, 14080

  • Local Institution - 0139

    Monterrey, Nuevo León, 66460

  • Local Institution - 0127

    Morelia, Michoacán, 58260

  • Local Institution - 0125

    Oaxaca City, Oaxaca, 68020

  • Local Institution - 0124

    Puebla City, 72424

Other trials in Mexico

Turkey (Türkiye)8 sites

  • Local Institution - 0400

    Ankara, 06100

  • Local Institution - 0405

    Ankara, 06100

  • Local Institution - 0422

    Ankara, 06170

  • Local Institution - 0401

    Ankara, 06200

  • Local Institution - 0406

    Izmir, 35100

  • Local Institution - 0403

    Mersin, 33440

  • Local Institution - 0407

    Samsun, 55270

  • Local Institution - 0402

    Trabzon, 61080

Other trials in Turkey (Türkiye)

India7 sites

  • Local Institution - 0411

    Belagavi, Karnataka, 590010

  • Local Institution - 0413

    Howrah, West Bengal, 711103

  • Local Institution - 0430

    Kochi, Kerala, 682027

  • Local Institution - 0154

    Mumbai, Maharashtra, 400012

  • Local Institution - 0433

    New Delhi, National Capital Territory of Delhi, 110029

  • Local Institution - 0469

    New Delhi, National Capital Territory of Delhi, 110085

  • Local Institution - 0410

    New Town, West Bengal, 700160

Other trials in India

Argentina6 sites

  • Local Institution - 0113

    Buenos Aires, Buenos Aires F.D., C1118AAT

  • Local Institution - 0421

    Buenos Aires, Buenos Aires F.D., C1417DTB

  • Local Institution - 0112

    Buenos Aires, 1426

  • Local Institution - 0119

    Buenos Aires, C1426ANZ

  • Local Institution - 0136

    Buenos Aires, C1431FWO

  • Local Institution - 0111

    Córdoba, 5016

Other trials in Argentina

Chile6 sites

  • Local Institution - 0106

    Santiago, Santiago Metropolitan, 7500921

  • Local Institution - 0107

    Santiago, Santiago Metropolitan, 7580206

  • Local Institution - 0108

    Santiago, Santiago Metropolitan, 7620002

  • Local Institution - 0110

    Santiago, Santiago Metropolitan, 8320325

  • Local Institution - 0459

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0164

    Viña del Mar, Valparaiso, 0

Other trials in Chile

Czechia6 sites

  • Local Institution - 0105

    Brno, Brno-město, 625 00

  • Local Institution - 0104

    Hradec Králové, Hradec Králové, 500 05

  • Local Institution - 0102

    Olomouc, Olomouc Region, 779 00

  • Local Institution - 0120

    Pilsen, Plzeň Region, 305 99

  • Local Institution - 0103

    Prague, Praha 10, 100 34

  • Local Institution - 0243

    Prague, 12808

Other trials in Czechia

Hungary6 sites

  • Local Institution - 0163

    Budapest, 1088

  • Local Institution - 0160

    Budapest, 1122

  • Local Institution - 0266

    Debrecen, Hajdú-Bihar, 4032

  • Local Institution - 0162

    Kaposvár, Somogy County, 7400

  • Local Institution - 0353

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Local Institution - 0161

    Szombathely, Vas County, 9700

Other trials in Hungary

Poland6 sites

  • Local Institution - 0336

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Local Institution - 0330

    Katowice, Silesian Voivodeship, 40-027

  • Local Institution - 0201

    Krakow, Lesser Poland Voivodeship, 30-727

  • Local Institution - 0337

    Lublin, Lublin Voivodeship, 20-090

  • Local Institution - 0388

    Skórzewo, Greater Poland Voivodeship, 60-185

  • Local Institution - 0443

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Greece5 sites

  • Local Institution - 0398

    Alexandroupoli, Anatolikí Makedonía Kai Thráki, 681 00

  • Local Institution - 0399

    Athens, Attikí, 106 76

  • Local Institution - 0396

    Athens, Attikí, 11527

  • Local Institution - 0397

    Chaïdári, Attikí, 12462

  • Local Institution - 0395

    Ioannina, Ípeiros, 455 00

Other trials in Greece

Canada4 sites

  • Local Institution - 0153

    Montreal, Quebec, H3T 1M5

  • Local Institution - 0073

    Montreal, Quebec, H4J 1C5

  • Local Institution - 0004

    Sherbrooke, Quebec, J1H 5N4

  • Local Institution - 0091

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Finland4 sites

  • Local Institution - 0280

    Helsinki, 00029

  • Local Institution - 0283

    Kuopio, Northern Savonia, 70210

  • Local Institution - 0281

    Oulu, North Ostrobothnia, 90220

  • Local Institution - 0282

    Turku, Southwest Finland, 20521

Other trials in Finland

Italy4 sites

  • Local Institution - 0496

    Novara, 28100

  • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO

    Palermo, Sicily, 90146

  • Local Institution - 0495

    Ravenna, Emilia-Romagna, 48121

  • Local Institution - 0493

    Rome, Lazio, 00168

Other trials in Italy

Malaysia4 sites

  • Local Institution - 0449

    Ampang, Selangor, 68000

  • Local Institution - 0432

    George Town, Pulau Pinang, 10990

  • Local Institution - 0431

    Kuching, Sarawak, 93586

  • Local Institution - 0453

    Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

Saudi Arabia4 sites

  • Local Institution - 0439

    Dammam, Eastern Province, 31444

  • Local Institution - 0438

    Jeddah, 22384

  • Local Institution - 0445

    Riyadh, Riyadh Region, 11426

  • Local Institution - 0416

    Riyadh, 12713

Other trials in Saudi Arabia

Sweden4 sites

  • Local Institution - 0278

    Linköping, Östergötlands Län [se-05], 581 85

  • Local Institution - 0279

    Lund, Skåne Län [se-12], 22185

  • Local Institution - 0487

    Solna, Stockholms Län [se-01], 171 64

  • Local Institution - 0277

    Uppsala, Uppsala Län [se-03], 751 85

Other trials in Sweden

Thailand4 sites

  • Local Institution - 0434

    Bangkok, Bangkok, 10330

  • Ramathibodi Hospital

    Bangkok, Bangkok, 10400

  • Faculty of Medicine Siriraj Hospital

    Bangkok, Bangkok, 10700

  • Local Institution - 0428

    Chiang Mai, 50200

Other trials in Thailand

Austria3 sites

  • Local Institution - 0387

    Linz, 4020

  • Local Institution - 0386

    Vienna, 1140

  • Local Institution - 0385

    Wels, Upper Austria, 4600

Other trials in Austria

Bulgaria3 sites

  • Local Institution - 0393

    Plovdiv, 4002

  • Local Institution - 0392

    Sofia, 1407

  • Local Institution - 0394

    Sofia, 1431

Other trials in Bulgaria

New Zealand3 sites

  • Local Institution - 0462

    Auckland, 1023

  • Local Institution - 0367

    Dunedin, Otago, 9016

  • Local Institution - 0366

    Hamilton, Waikato Region, 3240

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Colombia2 sites

  • Local Institution - 0130

    Bogota, Cundinamarca, 111151

  • Local Institution - 0129

    Bogotá, Bogota D.C., 110131

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Denmark2 sites

  • Local Institution - 0285

    Aarhus, Central Jutland, 8200

  • Local Institution - 0284

    Odense, Region Syddanmark, 5000

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Netherlands2 sites

  • Local Institution - 0499

    Groningen, 9713 GZ

  • Local Institution - 0500

    Leiden, South Holland, 2333 ZA

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Portugal2 sites

  • Local Institution - 0286

    Lisbon, 1500-650

  • Local Institution - 0098

    Porto, 4200-072

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Norway1 site

  • Local Institution - 0391

    Oslo, 0310

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Puerto Rico1 site

  • Local Institution - 0372

    San Juan, 00909

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Singapore1 site

  • Local Institution - 0427

    Singapore, Central Singapore, 168583

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Slovakia1 site

  • Local Institution - 0204

    Bratislava, 83101

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About this study

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)

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).

Being tested
Golcadomide, Placebo, Rituximab, Cyclophosphamide, Doxorubicin
Keywords
Lymphoma, Large B-Cell, Lymphoma, BMS-986369, CC-99282, DLBCL
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GolcadomideDrug

    Also called BMS-986369, CC-99282

    Specified dose on specified days

  • PlaceboDrug

    Specified dose on specified days

  • RituximabDrug

    Specified dose on specified days

  • CyclophosphamideDrug

    Specified dose on specified days

  • DoxorubicinDrug

    Specified dose on specified days

  • VincristineDrug

    Specified dose on specified days

  • PrednisoneDrug

    Specified dose on specified days

Study groups in NCT06356129
Study groupRoleWhat they receive
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)ExperimentalNot described
Receives: Drug: Golcadomide; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone
Placebo + R-CHOPPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) assessed by the Investigator

    Measured: Approximately 24 months after the last participant's first treatment

Secondary outcomes (20)

  1. PFS assessed by the Investigator

    Measured: Approximately 24 months after the last participant's first treatment

  2. Overall survival (OS)

    Measured: Up to approximately 67 months

  3. Event-free survival (EFS)

    Measured: Approximately 24 months after the last participant's first treatment

  4. Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC)

    Measured: Up to approximately 18 weeks

  5. Minimal residual disease (MRD) negativity rate

    Measured: Up to approximately 18 weeks

  6. Progression-free survival (PFS) assessed by the IRAC

    Measured: Approximately 24 months after the last participant's first treatment

  7. Objective response (OR) assessed by the Investigator

    Measured: Up to approximately 18 weeks

  8. Complete metabolic response (CMR) assessed by the Investigator

    Measured: Up to approximately 18 weeks

  9. PFS24 assessed by the Investigator 24 months after randomization

    Measured: Up to 24 months

  10. Duration of response (DoR)

    Measured: Up to approximately 67 months

  11. Second progression-free survival (PFS2) assessed by the Investigator

    Measured: Up to approximately 67 months

  12. Relative dose intensity (%)

    Measured: Up to 18 weeks

  13. 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

    Measured: Up to approximately 67 months

  14. Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire

    Measured: Up to approximately 67 months

  15. Mean change from baseline in the EORTC QLQ-C30

    Measured: Up to approximately 67 months

  16. Mean change from baseline in the FACT-LymS

    Measured: Up to approximately 67 months

  17. Number of participants with Adverse Events (AEs)

    Measured: Up to approximately 22 weeks

  18. Number of participants with treatment-emergent adverse events (TEAEs)

    Measured: Up to approximately 22 weeks

  19. Number of participants with laboratory abnormalities

    Measured: Up to approximately 22 weeks

  20. Number of participants with vital sign abnormalities

    Measured: Up to approximately 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start19 Jun 2024
  3. Primary completion9 Aug 2027 (estimated)
  4. Study completion26 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
850 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06356129
Sponsor's protocol ID
CA073-1020
Other IDs
2023-510178-15, U1111-1300-8493, 2023
Acronym
GOLSEEK-1
Status last verified
Jul 2026
First submitted
27 Mar 2024
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Golcadomide, Rituximab and Cyclophosphamide in people with Large B-cell Lymphoma, run by Celgene at 325 sites in 38 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 325 sites in United States, China, Japan, France, Brazil and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) assessed by the Investigator (time frame: Approximately 24 months after the last participant's first treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06356129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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