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

NCT06356129 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CA073-10202023-510178-15U1111-1300-8493
• Study Type: interventional
• Target: 850
• Locations: 37 countries
• Sites: 322

Brief 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).

Conditions

Large B-cell Lymphoma

Keywords

Lymphoma, Large B-Cell; Lymphoma; BMS-986369; CC-99282; DLBCL

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) assessed by the Investigator

  Up to approximately 67 months

Secondary Outcomes (20)

• PFS assessed by the Investigator

  Up to approximately 67 months

• Overall survival (OS)

  Up to approximately 67 months

• Event-free survival (EFS)

  Up to approximately 67 months

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

  Up to approximately 18 weeks

• Minimal residual disease (MRD) negativity rate

  Up to approximately 18 weeks

Study Arms (2)

Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)

EXPERIMENTAL

Drug: Golcadomide; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

Placebo + R-CHOP

PLACEBO COMPARATOR

Drug: Placebo; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

Interventions

Golcadomide DRUG

Specified dose on specified days

Also known as: BMS-986369, CC-99282

Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)

Placebo DRUG

Specified dose on specified days

Placebo + R-CHOP

Rituximab DRUG

Specified dose on specified days

Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone); Placebo + R-CHOP

Cyclophosphamide DRUG

Specified dose on specified days

Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone); Placebo + R-CHOP

Doxorubicin DRUG

Specified dose on specified days

Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone); Placebo + R-CHOP

Vincristine DRUG

Specified dose on specified days

Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone); Placebo + R-CHOP

Prednisone DRUG

Specified dose on specified days

Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone); Placebo + R-CHOP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (325)

Local Institution - 0014

Mobile, Alabama, 36604, United States

Location

Local Institution - 0477

Anchorage, Alaska, 99508, United States

Location

Local Institution - 0452

Phoenix, Arizona, 85054, United States

Location

Local Institution - 0342

San Francisco, California, 94143, United States

Location

Local Institution - 0497

Fort Myers, Florida, 33901, United States

Location

Local Institution - 0287

Jacksonville, Florida, 32224, United States

Location

Local Institution - 0415

Margate, Florida, 33063, United States

Location

Local Institution - 0045

Miami Beach, Florida, 33140, United States

Location

Local Institution - 0012

Pensacola, Florida, 32504, United States

Location

Local Institution - 0502

St. Petersburg, Florida, 33705, United States

Location

Local Institution - 0414

Tampa, Florida, 33612, United States

Location

Local Institution - 0192

West Palm Beach, Florida, 33401, United States

Location

Local Institution - 0485

Weston, Florida, 33331, United States

Location

Local Institution - 0515

Atlanta, Georgia, 30303, United States

Location

Local Institution - 0303

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0182

Chicago, Illinois, 60611, United States

Location

Local Institution - 0048

Skokie, Illinois, 60077, United States

Location

Local Institution - 0461

Waukee, Iowa, 50309, United States

Location

Local Institution - 0031

Westwood, Kansas, 66205, United States

Location

Local Institution - 0436

Edgewood, Kentucky, 41017, United States

Location

Local Institution - 0408

Baton Rouge, Louisiana, 70809, United States

Location

Local Institution - 0478

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0067

Minneapolis, Minnesota, 55407, United States

Location

Local Institution - 0203

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0437

Kansas City, Missouri, 64132, United States

Location

Local Institution - 0466

Reno, Nevada, 89511, United States

Location

Local Institution - 0498

East Brunswick, New Jersey, 08816, United States

Location

Local Institution - 0480

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0049

Morristown, New Jersey, 07960, United States

Location

Local Institution - 0175

New Brunswick, New Jersey, 08901, United States

Location

Local Institution - 0190

Buffalo, New York, 14263, United States

Location

Local Institution - 0451

East Syracuse, New York, 13057, United States

Location

Local Institution - 0484

New York, New York, 10016, United States

Location

Local Institution - 0369

New York, New York, 10028, United States

Location

Local Institution - 0176

New York, New York, 10029, United States

Location

Local Institution - 0174

Chapel Hill, North Carolina, 27599, United States

Location

Local Institution - 0066

Massillon, Ohio, 44646, United States

Location

Local Institution - 0450

Tulsa, Oklahoma, 74146, United States

Location

Local Institution - 0179

Portland, Oregon, 97239, United States

Location

Local Institution - 0009

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 0419

York, Pennsylvania, 17403, United States

Location

Local Institution - 0435

Fort Sam Houston, Texas, 78234, United States

Location

Local Institution - 0516

Houston, Texas, 77026, United States

Location

Local Institution - 0046

Houston, Texas, 77030, United States

Location

Local Institution - 0424

Houston, Texas, 77030, United States

Location

Local Institution - 0293

Richmond, Virginia, 23298, United States

Location

Local Institution - 0113

Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina

Location

Local Institution - 0421

Buenos Aires, Buenos Aires F.D., C1417DTB, Argentina

Location

Local Institution - 0112

Buenos Aires, 1426, Argentina

Location

Local Institution - 0119

Buenos Aires, C1426ANZ, Argentina

Location

Local Institution - 0136

Buenos Aires, C1431FWO, Argentina

Location

Local Institution - 0111

Córdoba, 5016, Argentina

Location

Local Institution - 0357

Gosford, New South Wales, 2250, Australia

Location

Local Institution - 0361

Sydney, New South Wales, 2560, Australia

Location

Local Institution - 0358

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0363

Tiwi, Northern Territory, 0810, Australia

Location

Local Institution - 0356

Birtinya, Queensland, 4575, Australia

Location

Local Institution - 0360

Southport, Queensland, 4215, Australia

Location

Local Institution - 0365

Frankston, Victoria, 3195, Australia

Location

Local Institution - 0362

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0359

St Albans, Victoria, 3021, Australia

Location

Local Institution - 0364

Warrnambool, Victoria, 3280, Australia

Location

Local Institution - 0385

Wels, Upper Austria, 4600, Austria

Location

Local Institution - 0387

Linz, 4020, Austria

Location

Local Institution - 0386

Vienna, 1140, Austria

Location

Local Institution - 0255

Fortaleza, Ceará, 60115-281, Brazil

Location

Local Institution - 0297

Lago Sul, Federal District, 71635580, Brazil

Location

Local Institution - 0256

Goiânia, Goiás, 74605-020, Brazil

Location

Local Institution - 0302

Curitiba, Paraná, 81520-060, Brazil

Location

Local Institution - 0296

Niterói, Rio de Janeiro, 24020-096, Brazil

Location

Local Institution - 0304

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Local Institution - 0253

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Local Institution - 0246

Chapecó, Santa Catarina, 89812-210, Brazil

Location

Local Institution - 0247

Joinville, Santa Catarina, 89201260, Brazil

Location

Local Institution - 0250

Barretos, São Paulo, 14784400, Brazil

Location

Local Institution - 0249

Jaú, São Paulo, 17210-120, Brazil

Location

Local Institution - 0301

São José do Rio Preto, São Paulo, 15090000, Brazil

Location

Local Institution - 0248

São Paulo, São Paulo, 01323-903, Brazil

Location

Local Institution - 0316

São Paulo, São Paulo, 01509-010, Brazil

Location

Local Institution - 0298

Rio de Janeiro, 22061-080, Brazil

Location

Local Institution - 0294

São Paulo, 01409-901, Brazil

Location

Local Institution - 0252

São Paulo, 04543-000, Brazil

Location

Local Institution - 0317

São Paulo, 05403-000, Brazil

Location

Local Institution - 0251

São Paulo, 05652-900, Brazil

Location

Local Institution - 0393

Plovdiv, 4002, Bulgaria

Location

Local Institution - 0392

Sofia, 1407, Bulgaria

Location

Local Institution - 0394

Sofia, 1431, Bulgaria

Location

Local Institution - 0091

Victoria, British Columbia, V8R 6V5, Canada

Location

Local Institution - 0153

Montreal, Quebec, H3T 1M5, Canada

Location

Local Institution - 0073

Montreal, Quebec, H4J 1C5, Canada

Location

Local Institution - 0004

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Local Institution - 0164

Viña del Mar, Región de Valparaíso, 0, Chile

Location

Local Institution - 0106

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Local Institution - 0107

Santiago, Santiago Metropolitan, 7580206, Chile

Location

Local Institution - 0108

Santiago, Santiago Metropolitan, 7620002, Chile

Location

Local Institution - 0110

Santiago, Santiago Metropolitan, 8320325, Chile

Location

Local Institution - 0459

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0195

Beijing, Beijing Municipality, 100091, China

Location

Local Institution - 0236

Chongqing, Chongqing Municipality, 400016, China

Location

Local Institution - 0196

Chongqing, Chongqing Municipality, 400030, China

Location

Local Institution - 0274

Fuzhou, Fujian, 350014, China

Location

Local Institution - 0157

Xiamen, Fujian, 361003, China

Location

Local Institution - 0133

Guangzhou, Guangdong, 510515, China

Location

Local Institution - 0240

Guangzhou, Guangdong, 510555, China

Location

Local Institution - 0338

Nanning, Guangxi, 530021, China

Location

Local Institution - 0239

Harbin, Heilongjiang, 150081, China

Location

Local Institution - 0238

Zhengzhou, Henan, 450008, China

Location

Local Institution - 0346

Wuhan, Hubei, 430022, China

Location

Local Institution - 0214

Wuhan, Hubei, 430030, China

Location

Local Institution - 0275

Changsha, Hunan, 410013, China

Location

Local Institution - 0156

Suzhou, Jiangsu, 215006, China

Location

Local Institution - 0237

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0241

Nanchang, Jiangxi, 330029, China

Location

Local Institution - 0291

Changchun, Jilin, 130021, China

Location

Local Institution - 0334

Shenyang, Liaoning, 110004, China

Location

Local Institution - 0169

Shenyang, Liaoning, 110015, China

Location

Local Institution - 0242

Jinan, Shandong, 250012, China

Location

Local Institution - 0344

Jinan, Shandong, 250117, China

Location

Local Institution - 0132

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution - 0339

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0234

Taiyuan, Shanxi, 030032, China

Location

Local Institution - 0141

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0470

Tianjin, Tianjin Municipality, 300060, China

Location

Local Institution - 0467

Ürümqi, Xinjiang, 830000, China

Location

Local Institution - 0197

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0483

Hangzhou, Zhejiang, 310052, China

Location

Local Institution - 0457

Wenzhou, Zhejiang, 325000, China

Location

Local Institution - 0129

Bogotá, Bogota D.C., 110131, Colombia

Location

Local Institution - 0130

Bogota, Cundinamarca, 111151, Colombia

Location

Local Institution - 0105

Brno, Brno-město, 625 00, Czechia

Location

Local Institution - 0104

Hradec Králové, Hradec Králové, 500 05, Czechia

Location

Local Institution - 0102

Olomouc, Olomoucký kraj, 779 00, Czechia

Location

Local Institution - 0120

Pilsen, Plzeň Region, 305 99, Czechia

Location

Local Institution - 0103

Prague, Praha 10, 100 34, Czechia

Location

Local Institution - 0243

Prague, 12808, Czechia

Location

Local Institution - 0285

Aarhus, Central Jutland, 8200, Denmark

Location

Local Institution - 0284

Odense, Region Syddanmark, 5000, Denmark

Location

Local Institution - 0281

Oulu, North Ostrobothnia, 90220, Finland

Location

Local Institution - 0283

Kuopio, Northern Savonia, 70210, Finland

Location

Local Institution - 0282

Turku, Southwest Finland, 20521, Finland

Location

Local Institution - 0280

Helsinki, 00029, Finland

Location

Local Institution - 0083

Nice, Alpes-Maritimes, 06202, France

Location

Local Institution - 0084

Strasbourg, Alsace, 67033, France

Location

Local Institution - 0090

Bordeaux, Aquitaine, 33076, France

Location

Local Institution - 0324

Pessac, Aquitaine, 33600, France

Location

Local Institution - 0087

Marseille, Bouches-du-Rhône, 13273, France

Location

Local Institution - 0292

Dijon, Côte-d'Or, 21000, France

Location

Local Institution - 0486

Besançon, Doubs, 25000, France

Location

Local Institution - 0332

Brest, Finistère, 29200, France

Location

Local Institution - 0202

Lille, Hauts-de-France, 59020, France

Location

Local Institution - 0335

Saint-Cloud, Hauts-de-Seine, 92210, France

Location

Local Institution - 0079

Tours, Indre-et-Loire, 37032, France

Location

Local Institution - 0223

La Tronche, Isère, 38700, France

Location

Local Institution - 0323

Saint-Pierre, La Réunion, 97448, France

Location

Local Institution - 0074

Montpellier, Languedoc-Roussillon, 34295, France

Location

Local Institution - 0081

Lille, Nord, 59000, France

Location

Local Institution - 0325

Nantes, Pays de la Loire Region, 44000, France

Location

Local Institution - 0321

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

Location

Local Institution - 0089

Pierre-Bénite, Rhône, 69310, France

Location

Local Institution - 0200

Créteil, Val-de-Marne, 94010, France

Location

Local Institution - 0076

Villejuif, Val-de-Marne, 94800, France

Location

Local Institution - 0306

Poitiers, Vienne, 86021, France

Location

Local Institution - 0244

Bayonne, 64109, France

Location

Local Institution - 0315

Caen, 14033, France

Location

Local Institution - 0077

Paris, 75010, France

Location

Local Institution - 0511

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Local Institution - 0383

Augsburg, Bavaria, 86156, Germany

Location

Local Institution - 0512

Bayreuth, Bavaria, 95445, Germany

Location

Local Institution - 0505

Erlangen, Bavaria, 91054, Germany

Location

Local Institution - 0507

Langen, Hesse, 63225, Germany

Location

Local Institution - 0513

Hanover, Lower Saxony, 30459, Germany

Location

Local Institution - 0384

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

Local Institution - 0504

Halle, Saxony-Anhalt, 06120, Germany

Location

Local Institution - 0506

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Local Institution - 0508

Berlin, 10967, Germany

Location

Local Institution - 0503

Cottbus, 03048, Germany

Location

Local Institution - 0510

Dresden, 01307, Germany

Location

Local Institution - 0370

Essen, 45122, Germany

Location

Local Institution - 0398

Alexandroupoli, Anatolikí Makedonía Kai Thráki, 681 00, Greece

Location

Local Institution - 0399

Athens, Attikí, 106 76, Greece

Location

Local Institution - 0396

Athens, Attikí, 11527, Greece

Location

Local Institution - 0397

Chaïdári, Attikí, 12462, Greece

Location

Local Institution - 0395

Ioannina, Ípeiros, 455 00, Greece

Location

Local Institution - 0266

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Local Institution - 0162

Kaposvár, Somogy County, 7400, Hungary

Location

Local Institution - 0353

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Local Institution - 0161

Szombathely, Vas County, 9700, Hungary

Location

Local Institution - 0163

Budapest, 1088, Hungary

Location

Local Institution - 0160

Budapest, 1122, Hungary

Location

Local Institution - 0411

Belagavi, Karnataka, 590010, India

Location

Local Institution - 0430

Kochi, Kerala, 682027, India

Location

Local Institution - 0154

Mumbai, Maharashtra, 400012, India

Location

Local Institution - 0433

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Local Institution - 0469

New Delhi, National Capital Territory of Delhi, 110085, India

Location

Local Institution - 0413

Howrah, West Bengal, 711103, India

Location

Local Institution - 0410

New Town, West Bengal, 700160, India

Location

Local Institution - 0495

Ravenna, Emilia-Romagna, 48121, Italy

Location

Local Institution - 0493

Rome, Lazio, 00168, Italy

Location

Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO

Palermo, Sicily, 90146, Italy

Location

Local Institution - 0496

Novara, 28100, Italy

Location

Local Institution - 0371

Nagoya, Aichi-ken, 466-8560, Japan

Location

Local Institution - 0168

Kashiwa, Chiba, 277-8577, Japan

Location

Local Institution - 0475

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

Location

Local Institution - 0271

Ōgaki, Gifu, 503-8502, Japan

Location

Local Institution - 0368

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 0327

Sapporo, Hokkaido, 064-0804, Japan

Location

Local Institution - 0273

Amagasaki, Hyōgo, 660-8550, Japan

Location

Local Institution - 0328

Himeji, Hyōgo, 670-8540, Japan

Location

Local Institution - 0270

Kanazawa, Ishikawa-ken, 920-8530, Japan

Location

Local Institution - 0343

Morioka, Iwate, 020-0066, Japan

Location

Local Institution - 0170

Isehara, Kanagawa, 259-1193, Japan

Location

Local Institution - 0333

Yokohama, Kanagawa, 221-0855, Japan

Location

Local Institution - 0320

Sendai, Miyagi, 980-8574, Japan

Location

Local Institution - 0166

Sakai, Osaka, 590-0197, Japan

Location

Local Institution - 0269

Hidaka, Saitama, 350-1298, Japan

Location

Local Institution - 0288

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

Location

Local Institution - 0350

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Local Institution - 0268

Itabashiku, Tokyo, 173-8610, Japan

Location

Local Institution - 0331

Chūō, Yamanashi, 409-3898, Japan

Location

Local Institution - 0348

Fukuoka, 810-8563, Japan

Location

Local Institution - 0319

Fukuoka, 811-1395, Japan

Location

Local Institution - 0313

Fukuoka, 812-8582, Japan

Location

Local Institution - 0272

Hiroshima, 7348551, Japan

Location

Local Institution - 0171

Kumamoto, 860-0008, Japan

Location

Local Institution - 0215

Kyoto, 602-8566, Japan

Location

Local Institution - 0329

Okayama, 700-8558, Japan

Location

Local Institution - 0322

Osaka, 543-8555, Japan

Location

Local Institution - 0347

Osaka, 545-8586, Japan

Location

Local Institution - 0167

Yamagata, 990-9585, Japan

Location

Local Institution - 0453

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

Local Institution - 0432

George Town, Pulau Pinang, 10990, Malaysia

Location

Local Institution - 0431

Kuching, Sarawak, 93586, Malaysia

Location

Local Institution - 0449

Ampang, Selangor, 68000, Malaysia

Location

Local Institution - 0122

Mexico City, DIF, 03100, Mexico

Location

Local Institution - 0121

Mexico City, DIF, 14080, Mexico

Location

Local Institution - 0128

Mexico City, Mexico City, 06720, Mexico

Location

Local Institution - 0126

Mexico City, Mexico City, 14080, Mexico

Location

Local Institution - 0127

Morelia, Michoacán, 58260, Mexico

Location

Local Institution - 0139

Monterrey, Nuevo León, 66460, Mexico

Location

Local Institution - 0125

Oaxaca City, Oaxaca, 68020, Mexico

Location

Local Institution - 0124

Puebla City, 72424, Mexico

Location

Local Institution - 0500

Leiden, South Holland, 2333 ZA, Netherlands

Location

Local Institution - 0499

Groningen, 9713 GZ, Netherlands

Location

Local Institution - 0367

Dunedin, Otago, 9016, New Zealand

Location

Local Institution - 0366

Hamilton, Waikato Region, 3240, New Zealand

Location

Local Institution - 0462

Auckland, 1023, New Zealand

Location

Local Institution - 0391

Oslo, 0310, Norway

Location

Local Institution - 0388

Skórzewo, Greater Poland Voivodeship, 60-185, Poland

Location

Local Institution - 0336

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

Local Institution - 0201

Krakow, Lesser Poland Voivodeship, 30-727, Poland

Location

Local Institution - 0337

Lublin, Lublin Voivodeship, 20-090, Poland

Location

Local Institution - 0443

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Local Institution - 0330

Katowice, Silesian Voivodeship, 40-027, Poland

Location

Local Institution - 0286

Lisbon, 1500-650, Portugal

Location

Local Institution - 0098

Porto, 4200-072, Portugal

Location

Local Institution - 0372

San Juan, 00909, Puerto Rico

Location

Local Institution - 0381

Bucharest, București, 022328, Romania

Location

Local Institution - 0417

Tg.Mures, Mureș County, 540136, Romania

Location

Local Institution - 0380

Brasov, 500052, Romania

Location

Local Institution - 0374

Bucharest, 022328, Romania

Location

Local Institution - 0377

Bucharest, 030171, Romania

Location

Local Institution - 0382

Bucharest, 030171, Romania

Location

Local Institution - 0378

Bucharest, 050098, Romania

Location

Local Institution - 0423

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0379

Iași, 700483, Romania

Location

Local Institution - 0376

Sibiu, 557260, Romania

Location

Local Institution - 0439

Dammam, Eastern Province, 31444, Saudi Arabia

Location

Local Institution - 0445

Riyadh, Riyadh Region, 11426, Saudi Arabia

Location

Local Institution - 0438

Jeddah, 22384, Saudi Arabia

Location

Local Institution - 0416

Riyadh, 12713, Saudi Arabia

Location

Local Institution - 0427

Singapore, Central Singapore, 168583, Singapore

Location

Local Institution - 0204

Bratislava, 83101, Slovakia

Location

Local Institution - 0149

Goyang-si, Kyǒnggi-do, 10408, South Korea

Location

Local Institution - 0456

Seongnam, Kyǒnggi-do, 13620, South Korea

Location

Local Institution - 0233

Suwon, Kyǒnggi-do, 16499, South Korea

Location

Local Institution - 0115

Busan, Pusan-Kwangyǒkshi, 49201, South Korea

Location

Local Institution - 0114

Busan, Pusan-Kwangyǒkshi, 49241, South Korea

Location

Local Institution - 0131

Busan, Pusan-Kwangyǒkshi, 49267, South Korea

Location

Local Institution - 0143

Seoul, Seoul-teukbyeolsi [Seoul], 02841, South Korea

Location

Local Institution - 0069

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

Location

Local Institution - 0100

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Local Institution - 0068

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

Location

Local Institution - 0070

Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea

Location

Local Institution - 0441

Deagu, Taegu-Kwangyǒkshi, 41404, South Korea

Location

Local Institution - 0118

Seoul, 07345, South Korea

Location

Local Institution - 0412

A Coruña, A Coruña [La Coruña], 15006, Spain

Location

Local Institution - 0491

Badalona, Barcelona [Barcelona], 08916, Spain

Location

Local Institution - 0071

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

Location

Local Institution - 0389

Barakaldo, Bizkaia, 48903, Spain

Location

Local Institution - 0172

Santa Cruz de Tenerife, Canary Islands, 38010, Spain

Location

Local Institution - 0314

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Local Institution - 0096

Majadahonda, Madrid, Comunidad de, 28222, Spain

Location

Local Institution - 0409

El Palmar, Murcia, Murcia, Región de, 30120, Spain

Location

Local Institution - 0092

Málaga, Málaga, 29010, Spain

Location

Local Institution - 0095

Cáceres, 10003, Spain

Location

Local Institution - 0072

Madrid, 28006, Spain

Location

Local Institution - 0490

Madrid, 28007, Spain

Location

Local Institution - 0488

Madrid, 28040, Spain

Location

Local Institution - 0093

Salamanca, 37007, Spain

Location

Local Institution - 0489

Seville, 41013, Spain

Location

Local Institution - 0279

Lund, Skåne Län [se-12], 22185, Sweden

Location

Local Institution - 0487

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

Location

Local Institution - 0277

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

Location

Local Institution - 0278

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

Location

Local Institution - 0142

Chiayi City, Chiayi, 613, Taiwan

Location

Local Institution - 0146

Tainan, Tainan, 71004, Taiwan

Location

Local Institution - 0159

Kaohsiung City, 83301, Taiwan

Location

Local Institution - 0135

Taichung, 40447, Taiwan

Location

Local Institution - 0145

Taichung, 407, Taiwan

Location

Local Institution - 0134

Taipei, 10002, Taiwan

Location

Local Institution - 0514

Taipei, 11217, Taiwan

Location

Local Institution - 0147

Taipei, 112, Taiwan

Location

Local Institution - 0158

Taoyuan District, 333, Taiwan

Location

Local Institution - 0434

Bangkok, Bangkok, 10330, Thailand

Location

Ramathibodi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

Faculty of Medicine Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

Local Institution - 0428

Chiang Mai, 50200, Thailand

Location

Local Institution - 0400

Ankara, 06100, Turkey (Türkiye)

Location

Local Institution - 0405

Ankara, 06100, Turkey (Türkiye)

Location

Local Institution - 0422

Ankara, 06170, Turkey (Türkiye)

Location

Local Institution - 0401

Ankara, 06200, Turkey (Türkiye)

Location

Local Institution - 0406

Izmir, 35100, Turkey (Türkiye)

Location

Local Institution - 0403

Mersin, 33440, Turkey (Türkiye)

Location

Local Institution - 0407

Samsun, 55270, Turkey (Türkiye)

Location

Local Institution - 0402

Trabzon, 61080, Turkey (Türkiye)

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lymphoma

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 10, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): August 14, 2028
• Study Completion (Estimated): November 20, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (46); RO (10); ME (8); BU (3); GR (5); NO (1); DK (2); PR (1); IT (4); CA (4); AU (10); PT (2); SE (4); SA (4); SG (1); TW (9); HU (6); NZ (3); FI (4); CN (30); ES (15); FR (24); CO (2); SL (1); CL (6); DE (13); KR (13); TH (4); PL (6); AR (6); JP (29); IN (7); TU (8); CZ (6); MY (4); NL (2); BR (19)