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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
2029-06-26
Last Updated
2026-07-06
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 - 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 - 0164
Viña del Mar, Valparaiso, Chile
Local Institution - 0195
Beijing, Beijing Municipality, China
Local Institution - 0236
Chongqing, Chongqing Municipality, China
Local Institution - 0196
Chongqing, Chongqing Municipality, China