A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)

May 18, 2026 updated by: Celgene

A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) Vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy

The study is designed as a multicenter, randomized, open label Phase 3 study to compare the efficacy and safety of golcadomide in combination with rituximab vs investigator's choice in participants with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.

Study Overview

Status

Recruiting

Conditions

Follicular Lymphoma

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

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 Contact

Name: First line of the email MUST contain the NCT# and Site #.

Study Contact Backup

Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Phone Number: 8559073286
Email: Clinical.Trials@bms.com

Study Locations

Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - Recruiting
    - Westmead Hospital
    - Contact:
      
      Amanda Johnston, Site 0134
      
      Phone Number: 61288906352
- South Australia
  - Adelaide, South Australia, Australia, 5042
    - Not yet recruiting
    - Local Institution - 0132
    - Contact:
      
      Site 0132
- Tasmania
  - Hobart, Tasmania, Australia, 7000
    - Not yet recruiting
    - Local Institution - 0131
    - Contact:
      
      Site 0131
- Victoria
  - Heidelberg, Victoria, Australia, 3084
    - Not yet recruiting
    - Local Institution - 0128
    - Contact:
      
      Site 0128
  - Malvern, Victoria, Australia, 3144
    - Recruiting
    - Cabrini Hospital - Malvern
    - Contact:
      
      Adrian Minson, Site 0198
      
      Phone Number: 85595000
- Western Australia
  - Perth, Western Australia, Australia, 6000
    - Not yet recruiting
    - Local Institution - 0127
    - Contact:
      
      Site 0127
  - Perth, Western Australia, Australia, 6000
    - Withdrawn
    - Local Institution - 0224
Brazil
- - Rio de Janeiro, Brazil, 22250-905
    - Not yet recruiting
    - Local Institution - 0089
    - Contact:
      
      Site 0089
  - São Paulo, Brazil, 01246-000
    - Not yet recruiting
    - Local Institution - 0066
    - Contact:
      
      Site 0066
  - São Paulo, Brazil, 05652-900
    - Not yet recruiting
    - Local Institution - 0092
    - Contact:
      
      Site 0092
- Espírito Santo
  - Vitória, Espírito Santo, Brazil, 29041-295
    - Not yet recruiting
    - Local Institution - 0159
    - Contact:
      
      Site 0159
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
    - Not yet recruiting
    - Local Institution - 0087
    - Contact:
      
      Site 0087
- Rio de Janeiro
  - Niterói, Rio de Janeiro, Brazil, 24220-070
    - Not yet recruiting
    - Local Institution - 0088
    - Contact:
      
      Site 0088
- São Paulo
  - São Paulo, São Paulo, Brazil, 04543-000
    - Not yet recruiting
    - Local Institution - 0079
    - Contact:
      
      Site 0079
Canada
- British Columbia
  - Victoria, British Columbia, Canada, V8R 6V5
    - Not yet recruiting
    - Local Institution - 0200
    - Contact:
      
      Site 0200
- Ontario
  - Toronto, Ontario, Canada, M5G 2M9
    - Recruiting
    - Princess Margaret Cancer Centre
    - Contact:
      
      Robert Kridel, Site 0035
      
      Phone Number: 41694645012243
- Quebec
  - Québec, Quebec, Canada, G1J 1Z4
    - Not yet recruiting
    - Local Institution - 0250
    - Contact:
      
      Site 0250
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Not yet recruiting
    - Local Institution - 0192
    - Contact:
      
      Site 0192
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Withdrawn
    - Local Institution - 0226
Chile
- Santiago Metropolitan
  - Santiago, Santiago Metropolitan, Chile, 7580206
    - Not yet recruiting
    - Local Institution - 0154
    - Contact:
      
      Site 0154
  - Santiago, Santiago Metropolitan, Chile, 8320325
    - Not yet recruiting
    - Local Institution - 0155
    - Contact:
      
      Site 0155
  - Santiago, Santiago Metropolitan, Chile, 8420383
    - Not yet recruiting
    - Local Institution - 0153
    - Contact:
      
      Site 0153
      
      Phone Number: +358 8 669 9500
China
- - Zhengzhou, China, 450008
    - Not yet recruiting
    - Local Institution - 0174
    - Contact:
      
      Site 0174
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100142
    - Recruiting
    - Beijing Cancer Hospital
    - Contact:
      
      Yuqin Song, Site 0171
      
      Phone Number: 13683398726
  - Beijing, Beijing Municipality, China, 100038
    - Not yet recruiting
    - Local Institution - 0246
    - Contact:
      
      Site 0246
- Fujian
  - Fuzhou Fujian, Fujian, China, 350001
    - Not yet recruiting
    - Local Institution - 0172
    - Contact:
      
      Site 0172
- Guangdong
  - Guangzhou, Guangdong, China, 510060
    - Recruiting
    - Sun Yat-sen University Cancer Center
    - Contact:
      
      Zhiming Li, Site 0173
      
      Phone Number: +8613719189172
- Heilongjiang
  - Harbin, Heilongjiang, China, 150081
    - Not yet recruiting
    - Local Institution - 0241
    - Contact:
      
      Site 0241
- Hubei
  - Wuhan, Hubei, China, 430022
    - Recruiting
    - Union Hospital Tongji Medical College Huazhong University of Science and Technology
    - Contact:
      
      Liling Zhang, Site 0176
      
      Phone Number: 15871725926
- Hunan
  - Changsha, Hunan, China, 410008
    - Not yet recruiting
    - Local Institution - 0175
    - Contact:
      
      Site 0175
- Inner Mongolia
  - Hohhot, Inner Mongolia, China, 010020
    - Recruiting
    - Inner Mongolia Cancer Hospital
    - Contact:
      
      Ping Lingyan, Site 0235
      
      Phone Number: 13520201279
- Jiangsu
  - Suzhou, Jiangsu, China, 215006
    - Not yet recruiting
    - Local Institution - 0233
    - Contact:
      
      Site 0233
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Not yet recruiting
    - Local Institution - 0178
    - Contact:
      
      Site 0178
- Jilin
  - Changchun, Jilin, China, 130000
    - Not yet recruiting
    - Local Institution - 0239
    - Contact:
      
      Site 0239
  - Changchun, Jilin, China, 130021
    - Not yet recruiting
    - Local Institution - 0177
    - Contact:
      
      Site 0177
- Liaoning
  - Shenyang, Liaoning, China, 110004
    - Not yet recruiting
    - Local Institution - 0179
    - Contact:
      
      Site 0179
  - Shenyang, Liaoning, China, 110042
    - Not yet recruiting
    - Local Institution - 0242
    - Contact:
      
      Site 0242
- Shandong
  - Jinan, Shandong, China, 250117
    - Recruiting
    - Shandong Cancer Hospital
    - Contact:
      
      Zengjun Li, Site 0180
      
      Phone Number: +8613642138692
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200032
    - Not yet recruiting
    - Local Institution - 0181
    - Contact:
      
      Site 0181
  - Shanghai, Shanghai Municipality, China, 200065
    - Not yet recruiting
    - Local Institution - 0249
    - Contact:
      
      Site 0249
- Sichuan
  - Sichuan, Sichuan, China, 646000
    - Not yet recruiting
    - Local Institution - 0234
    - Contact:
      
      Site 0234
- Tianjin Municipality
  - Tianjin, Tianjin Municipality, China, 300060
    - Not yet recruiting
    - Local Institution - 0182
    - Contact:
      
      Site 0182
  - Tianjin, Tianjin Municipality, China, 300121
    - Recruiting
    - Tianjin People' s Hospital
    - Contact:
      
      Xingli Zhao, Site 0227
      
      Phone Number: 13752255454
- Yunnan
  - Kunming, Yunnan, China, 650118
    - Not yet recruiting
    - Local Institution - 0248
    - Contact:
      
      Site 0248
- Zhejiang
  - Hangzhou, Zhejiang, China, 310022
    - Not yet recruiting
    - Local Institution - 0184
    - Contact:
      
      Site 0184
Finland
- - Helsinki, Finland, 00029
    - Not yet recruiting
    - Local Institution - 0150
    - Contact:
      
      Site 0150
      
      Phone Number: +358 9 4711
- North Ostrobothnia
  - Oulu, North Ostrobothnia, Finland, 90220
    - Not yet recruiting
    - Local Institution - 0151
    - Contact:
      
      Site 0151
      
      Phone Number: +358 8 669 9500
- Southwest Finland
  - Turku, Southwest Finland, Finland, 20521
    - Not yet recruiting
    - Local Institution - 0152
    - Contact:
      
      Site 0152
      
      Phone Number: +358 2 3130000
France
- - Paris, France, 75010
    - Not yet recruiting
    - Local Institution - 0191
    - Contact:
      
      Site 0191
  - Toulouse, France, 31100
    - Recruiting
    - Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
    - Contact:
      
      Loïc Ysebaert, Site 0121
      
      Phone Number: 33531156351
- Aquitaine
  - Pessac, Aquitaine, France, 33600
    - Recruiting
    - CHU Bordeaux Haut-Leveque
    - Contact:
      
      Francois-Xavier Gros, Site 0100
      
      Phone Number: 33557656511
- Hauts-de-Seine
  - Saint-Cloud, Hauts-de-Seine, France, 92210
    - Not yet recruiting
    - Local Institution - 0044
    - Contact:
      
      Site 0044
- Languedoc-Roussillon
  - Montpellier, Languedoc-Roussillon, France, 34295
    - Recruiting
    - Chu Saint Eloi
    - Contact:
      
      Guillaume Cartron, Site 0047
      
      Phone Number: +33675926918
- Loire-Atlantique
  - Nantes, Loire-Atlantique, France, 44093 Cedex 1
    - Recruiting
    - Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
    - Contact:
      
      Thomas Gastinne, Site 0120
      
      Phone Number: 33240083271
- Nord
  - Lille, Nord, France, 59037
    - Recruiting
    - Hopital Claude Huriez - CHU de Lille
    - Contact:
      
      Franck Morschhauser, Site 0048
      
      Phone Number: 33320445713
- Rhône
  - Pierre-Bénite, Rhône, France, 69310
    - Not yet recruiting
    - Local Institution - 0042
    - Contact:
      
      Site 0042
Germany
- - Chemnitz, Germany, 09116
    - Recruiting
    - Klinikum Chemnitz gGmbH
    - Contact:
      
      Mathias Haenel, Site 0165
      
      Phone Number: 4937133344500
  - Dresden, Germany, 01307
    - Recruiting
    - Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
    - Contact:
      
      Thomas Illmer, Site 0187
      
      Phone Number: 00493514400022
  - München, Germany, 81337
    - Not yet recruiting
    - Local Institution - 0162
    - Contact:
      
      Site 0162
  - Würzburg, Germany, 97080
    - Not yet recruiting
    - Local Institution - 0221
    - Contact:
      
      Site 0221
- Baden-Wurttemberg
  - Ulm, Baden-Wurttemberg, Germany, 89081
    - Not yet recruiting
    - Local Institution - 0163
    - Contact:
      
      Site 0163
- Bavaria
  - Augsburg, Bavaria, Germany, 86156
    - Recruiting
    - Klinikum Augsburg
    - Contact:
      
      Rainer Claus, Site 0161
      
      Phone Number: +491791098382
- Lower Saxony
  - Göttingen, Lower Saxony, Germany, 37075
    - Not yet recruiting
    - Local Institution - 0220
    - Contact:
      
      Site 0220
- North Rhine-Westphalia
  - Dortmund, North Rhine-Westphalia, Germany, 44263
    - Recruiting
    - GEFOS Gesellschaft f. onkologische Studien
    - Contact:
      
      Sandra Ketzler-Henkel, Site 0166
      
      Phone Number: 02312069011
  - Düsseldorf, North Rhine-Westphalia, Germany, 40225
    - Not yet recruiting
    - Local Institution - 0193
    - Contact:
      
      Site 0193
  - Münster, North Rhine-Westphalia, Germany, 48153
    - Withdrawn
    - Local Institution - 0231
  - Münster, North Rhine-Westphalia, Germany, 48153
    - Not yet recruiting
    - Local Institution - 0232
    - Contact:
      
      Site 0232
- Saarland
  - Homburg, Saarland, Germany, 66424
    - Recruiting
    - Universitaetsklinikum des Saarlandes
    - Contact:
      
      Konstantinos Christofyllakis, Site 0164
      
      Phone Number: +68411615358
- Thuringia
  - Erfurt, Thuringia, Germany, 99089
    - Recruiting
    - HELIOS Klinikum Erfurt
    - Contact:
      
      Sebastian Scholl, Site 0222
      
      Phone Number: +493617812476
  - Jena, Thuringia, Germany, 07747
    - Recruiting
    - Universitatsklinikum Jena
    - Contact:
      
      Ulf Schnetzke, Site 0167
      
      Phone Number: 036419327113
Greece
- Anatolikí Makedonía Kai Thráki
  - Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece, 681 00
    - Not yet recruiting
    - Local Institution - 0111
    - Contact:
      
      Site 0111
- Attikí
  - Athens, Attikí, Greece, 106 76
    - Recruiting
    - Evangelismos General Hospital of Athens
    - Contact:
      
      Maria Bouzani, Site 0109
      
      Phone Number: +302132041721
  - Αthens, Attikí, Greece, 11526
    - Recruiting
    - General Hospital of Athens "Laiko"
    - Contact:
      
      Theodoros Vassilakopoulos, Site 0107
      
      Phone Number: 302132061702
- Thessaloníki
  - Thessaloniki, Thessaloníki, Greece, 570 10
    - Not yet recruiting
    - Local Institution - 0110
    - Contact:
      
      Site 0110
  - Thessaloniki, Thessaloníki, Greece, 570 10
    - Not yet recruiting
    - Local Institution - 0197
    - Contact:
      
      Site 0197
- Ípeiros
  - Ioannina, Ípeiros, Greece, 455 00
    - Not yet recruiting
    - Local Institution - 0108
    - Contact:
      
      Site 0108
India
- Karnataka
  - Bengaluru, Karnataka, India, 560099
    - Not yet recruiting
    - Local Institution - 0139
    - Contact:
      
      Site 0139
- Maharashtra
  - Mumbai, Maharashtra, India, 400 057
    - Not yet recruiting
    - Local Institution - 0141
    - Contact:
      
      Site 0141
- National Capital Territory of Delhi
  - New Delhi, National Capital Territory of Delhi, India, 110029
    - Not yet recruiting
    - Local Institution - 0142
    - Contact:
      
      Site 0142
- Telangana
  - Hyderabad, Telangana, India, 500033
    - Not yet recruiting
    - Local Institution - 0140
    - Contact:
      
      Site 0140
  - Hyderabad, Telangana, India, 500082
    - Not yet recruiting
    - Local Institution - 0138
    - Contact:
      
      Site 0138
Italy
- - Alessandria, Italy, 15121
    - Not yet recruiting
    - Local Institution - 0102
    - Contact:
      
      Site 0102
  - Naples, Italy, 80131
    - Recruiting
    - Istituto Nazionale Tumori IRCCS Fondazione Pascale
    - Contact:
      
      Antonio Pinto, Site 0105
      
      Phone Number: 390815903382
  - Torino, Italy, 10126
    - Not yet recruiting
    - Local Institution - 0157
    - Contact:
      
      Site 0157
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italy, 40138
    - Not yet recruiting
    - Local Institution - 0104
    - Contact:
      
      Site 0104
  - Meldola, Emilia-Romagna, Italy, 47014
    - Recruiting
    - IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
    - Contact:
      
      Gerardo Musuraca, Site 0101
      
      Phone Number: +390543739292
- Milano
  - Rozzano, Milano, Italy, 20089
    - Recruiting
    - Istituto Clinico Humanitas
    - Contact:
      
      Armando Santoro, Site 0103
      
      Phone Number: 390282244080
- Tuscany
  - Pisa, Tuscany, Italy, 56126
    - Recruiting
    - Azienda Ospedaliero Universitaria Pisana
    - Contact:
      
      Sara Galimberti, Site 0106
      
      Phone Number: +393470038656
Japan
- - Fukuoka, Japan, 812-8582
    - Recruiting
    - Kyushu University Hospital
    - Contact:
      
      Kohta Miyawaki, Site 0208
      
      Phone Number: 81926425230
  - Fukuoka, Japan, 810-8563
    - Recruiting
    - National Hospital Organization Kyushu Medical Center
    - Contact:
      
      Ken Takase, Site 0209
      
      Phone Number: 81928520700
  - Hiroshima, Japan, 730-0052
    - Recruiting
    - Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
    - Contact:
      
      Tsuyoshi Muta, Site 0204
      
      Phone Number: 81822413111
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 466-8560
    - Recruiting
    - Nagoya University Hospital
    - Contact:
      
      Kazuyuki Shimada, Site 0205
      
      Phone Number: 81527442141
- Hokkaido
  - Sapporo, Hokkaido, Japan, 064-0804
    - Recruiting
    - Aiiku Hospital
    - Contact:
      
      Koh Izumiyama, Site 0202
      
      Phone Number: 81115632211
- Hyōgo
  - Himeji, Hyōgo, Japan, 670-8540
    - Recruiting
    - Japanease Red Cross Society Himeji Hospital
    - Contact:
      
      Takeru Asano, Site 0211
      
      Phone Number: +81-79-294-2251
- Iwate
  - Morioka, Iwate, Japan, 020-0066
    - Recruiting
    - Iwate Prefectural Central Hospital
    - Contact:
      
      Kazunori Murai, Site 0201
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-0045
    - Recruiting
    - National Cancer Center Hospital
    - Contact:
      
      Suguru Fukuhara, Site 0229
      
      Phone Number: 81335422511
  - Itabashiku, Tokyo, Japan, 173-8610
    - Recruiting
    - Nihon University Itabashi Hospital
    - Contact:
      
      Katsuhiro Miura, Site 0207
      
      Phone Number: +81-(0)3-3972-8111
- Yamanashi
  - Chūō, Yamanashi, Japan, 409-3898
    - Recruiting
    - University of Yamanashi Hospital
    - Contact:
      
      Ichiro Kawashima, Site 0210
      
      Phone Number: 0552731111
Netherlands
- - Groningen, Netherlands, 9713 GZ
    - Not yet recruiting
    - Local Institution - 0046
    - Contact:
      
      Site 0046
  - Utrecht, Netherlands, 3584 CX
    - Recruiting
    - Universitair Medisch Centrum Utrecht
    - Contact:
      
      Margot Jak, Site 0053
      
      Phone Number: +31887555878
- North Holland
  - Amsterdam, North Holland, Netherlands, 1081 HV
    - Recruiting
    - Amsterdam UMC, locatie VUmc
    - Contact:
      
      Sanne Tonino, Site 0050
      
      Phone Number: +31-20-5669111
Poland
- Greater Poland Voivodeship
  - Skórzewo, Greater Poland Voivodeship, Poland, 60-185
    - Recruiting
    - AIDPORT Sp. z o.o.
    - Contact:
      
      Michal Kwiatek, Site 0185
      
      Phone Number: +48793602210
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 30-727
    - Recruiting
    - Pratia MCM Krakow
    - Contact:
      
      Wojciech Jurczak, Site 0186
      
      Phone Number: +48602338290
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 02-781
    - Recruiting
    - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
    - Contact:
      
      Ewa Paszkiewicz-Kozik, Site 0188
      
      Phone Number: 48225462366
- Pomeranian Voivodeship
  - Gdynia, Pomeranian Voivodeship, Poland, 81-519
    - Not yet recruiting
    - Local Institution - 0190
    - Contact:
      
      Site 0190
- Łódź Voivodeship
  - Lodz, Łódź Voivodeship, Poland, 93-513
    - Not yet recruiting
    - Local Institution - 0189
    - Contact:
      
      Site 0189
Saudi Arabia
- - Riyadh, Saudi Arabia, 11426
    - Not yet recruiting
    - Local Institution - 0054
    - Contact:
      
      Site 0054
  - Riyadh, Saudi Arabia, 12713
    - Not yet recruiting
    - Local Institution - 0052
    - Contact:
      
      Site 0052
- Eastern Province
  - Dammam, Eastern Province, Saudi Arabia, 31444
    - Not yet recruiting
    - Local Institution - 0099
    - Contact:
      
      Site 0099
South Korea
- - Seoul, South Korea, 07345
    - Not yet recruiting
    - Local Institution - 0058
    - Contact:
      
      Site 0058
- Seoul-teukbyeolsi [Seoul]
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
    - Not yet recruiting
    - Local Institution - 0059
    - Contact:
      
      Site 0059
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
    - Not yet recruiting
    - Local Institution - 0060
    - Contact:
      
      Site 0060
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
    - Not yet recruiting
    - Local Institution - 0061
    - Contact:
      
      Site 0061
Spain
- - Granada, Spain, 18012
    - Recruiting
    - Hospital Universitario Virgen Nieves
    - Contact:
      
      Jose Puerta Puerta, Site 0126
      
      Phone Number: 0034958020013
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Local Institution - 0123
    - Contact:
      
      Site 0123
- Barcelona [Barcelona]
  - Sabadell, Barcelona [Barcelona], Spain, 08208
    - Recruiting
    - Hospital Universitari Parc Tauli
    - Contact:
      
      Xavier Vilaseca Creus, Site 0158
      
      Phone Number: +34937231010
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Recruiting
    - Hospital Universitario Marqués de Valdecilla
    - Contact:
      
      Sonia Gonzalez de Villambrosia, Site 0122
      
      Phone Number: 942292529Ext73188
- Madrid, Comunidad de
  - Madrid, Madrid, Comunidad de, Spain, 28031
    - Recruiting
    - Hospital Universitario Infanta Leonor
    - Contact:
      
      Jose Angel Hernandez Rivas, Site 0124
      
      Phone Number: 34619249275
- Valenciana, Comunitat
  - Valencia, Valenciana, Comunitat, Spain, 46010
    - Recruiting
    - Hospital Clinico de Valencia
    - Contact:
      
      Blanca Ferrer Lores, Site 0125
      
      Phone Number: 34963987649
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06100
    - Not yet recruiting
    - Local Institution - 0194
    - Contact:
      
      Site 0194
  - Antalya, Turkey (Türkiye), 07059
    - Not yet recruiting
    - Local Institution - 0196
    - Contact:
      
      Site 0196
  - Mersin, Turkey (Türkiye), 33343
    - Not yet recruiting
    - Local Institution - 0223
    - Contact:
      
      Site 0223
- Istanbul
  - Istanbul- Fatih, Istanbul, Turkey (Türkiye), 34098
    - Not yet recruiting
    - Local Institution - 0195
    - Contact:
      
      Site 0195
United Arab Emirates
- Abu Dhabi Emirate
  - Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 11001
    - Not yet recruiting
    - Local Institution - 0251
    - Contact:
      
      Site 0251
  - Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 92510
    - Not yet recruiting
    - Local Institution - 0252
    - Contact:
      
      Site 0252
United Kingdom
- - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - The Christie NHS Foundation Trust
    - Contact:
      
      Kim Linton, Site 0149
      
      Phone Number: 01614 463000
- England
  - Cringleford, England, United Kingdom, NR4 7UY
    - Recruiting
    - Norfolk and Norwich University Hospitals Nhs Foundation Trust
    - Contact:
      
      Joel Cunningham, Site 0148
      
      Phone Number: 01603 286286
- Kent
  - Canterbury, Kent, United Kingdom, CT1 3NG
    - Recruiting
    - Kent and Canterbury Hospital
    - Contact:
      
      Moya Young, Site 0147
      
      Phone Number: 01227 766877
- London, City of
  - London, London, City of, United Kingdom, W12 0HS
    - Not yet recruiting
    - Local Institution - 0213
    - Contact:
      
      Site 0213
United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - Not yet recruiting
    - Local Institution - 0225
    - Contact:
      
      Site 0225
  - Mobile, Alabama, United States, 36607
    - Recruiting
    - Infirmary Cancer Care
    - Contact:
      
      Furhan Yunus, Site 0014
      
      Phone Number: 901-634-5546
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Recruiting
    - Alaska Oncology and Hematology
    - Contact:
      
      Steven Liu, Site 0074
      
      Phone Number: 907-257-9851
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Not yet recruiting
    - Local Institution - 0215
    - Contact:
      
      Site 0215
- California
  - Duarte, California, United States, 91010
    - Recruiting
    - City of Hope Comprehensive Cancer Center
    - Contact:
      
      Alex Herrera, Site 0072
      
      Phone Number: 626-218-2405
  - San Francisco, California, United States, 94143
    - Recruiting
    - UCSF Helen Diller Medical Center at Parnassus Heights
    - Contact:
      
      Charalambos Andreadis, Site 0119
      
      Phone Number: 415-238-1909
- Florida
  - Jacksonville, Florida, United States, 32256
    - Not yet recruiting
    - Local Institution - 0008
    - Contact:
      
      Site 0008
  - Tampa, Florida, United States, 33606
    - Not yet recruiting
    - Local Institution - 0214
    - Contact:
      
      Site 0214
  - Tampa, Florida, United States, 33612
    - Not yet recruiting
    - Local Institution - 0217
    - Contact:
      
      Site 0217
- Georgia
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
    - Contact:
      
      Dean Kirkel, Site 0021
      
      Phone Number: 770-281-5100
  - Newnan, Georgia, United States, 30265
    - Recruiting
    - Southeastern Regional Medical Center
    - Contact:
      
      Sabarish Ayyappan, Site 0245
      
      Phone Number: 000-000-0000
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Not yet recruiting
    - Local Institution - 0240
    - Contact:
      
      Site 0240
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Not yet recruiting
    - Local Institution - 0253
    - Contact:
      
      Site 0253
  - Waukee, Iowa, United States, 50309
    - Not yet recruiting
    - Local Institution - 0243
    - Contact:
      
      Site 0243
- Kansas
  - Westwood, Kansas, United States, 66205
    - Not yet recruiting
    - Local Institution - 0216
    - Contact:
      
      Site 0216
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - Not yet recruiting
    - Local Institution - 0218
    - Contact:
      
      Site 0218
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Not yet recruiting
    - Local Institution - 0023
    - Contact:
      
      Site 0023
  - Towson, Maryland, United States, 21204
    - Recruiting
    - Greater Baltimore Medical Center
    - Contact:
      
      Zhuoyan Li, Site 0010
      
      Phone Number: 443-849-3051
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Not yet recruiting
    - Local Institution - 0145
    - Contact:
      
      Site 0145
  - Boston, Massachusetts, United States, 02215
    - Not yet recruiting
    - Local Institution - 0244
    - Contact:
      
      Site 0244
  - Boston, Massachusetts, United States, 02215
    - Not yet recruiting
    - Local Institution - 0247
    - Contact:
      
      Site 0247
- Mississippi
  - Hattiesburg, Mississippi, United States, 39401-7233
    - Recruiting
    - Hattiesburg Clinic Hematology/Oncology
    - Contact:
      
      John Hrom, Site 0013
      
      Phone Number: 601-261-1700
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Not yet recruiting
    - Local Institution - 0144
    - Contact:
      
      Site 0144
- Texas
  - Austin, Texas, United States, 78705
    - Recruiting
    - Texas Oncology - Central/South Texas
    - Contact:
      
      Jason Melear, Site 0237
      
      Phone Number: 512-427-9400
  - Fort Worth, Texas, United States, 76104
    - Not yet recruiting
    - Local Institution - 0212
    - Contact:
      
      Site 0212
  - San Antonio, Texas, United States, 78240
    - Not yet recruiting
    - Local Institution - 0230
    - Contact:
      
      Site 0230
  - Tyler, Texas, United States, 75702
    - Recruiting
    - Texas Oncology - Northeast Texas
    - Contact:
      
      Habte Yimer, Site 0236
      
      Phone Number: 903-579-9800
- Virginia
  - Fairfax, Virginia, United States, 22304
    - Not yet recruiting
    - Local Institution - 0238
    - Contact:
      
      Site 0238
  - Fredericksburg, Virginia, United States, 22408
    - Recruiting
    - Hematology Oncology Associates of Fredericksburg
    - Contact:
      
      Christopher Vaughn, Site 0030
      
      Phone Number: 540-371-0079
  - Roanoke, Virginia, United States, 24014
    - Recruiting
    - Blue Ridge Cancer Care
    - Contact:
      
      Amanda Gillespie-Twardy, Site 0146
      
      Phone Number: 540-982-0237
- Washington
  - Vancouver, Washington, United States, 98684
    - Not yet recruiting
    - Local Institution - 0143
    - Contact:
      
      Site 0143

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

Description

Inclusion Criteria:

- Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy from the latest relapse if available with corresponding pathology report for retrospective central pathology confirmation of relapse, is required. Evaluation from fine needle aspirate is not permitted.

- Relapsed or refractory disease: i) Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.

ii) Refractory FL is defined as best response of SD or PD or a response that lasted less than 6 months to the most recent prior therapy.

Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities).
Participant must have positron emission tomography (PET)-positive disease with at least one PET-positive lesion and measurable disease on cross section imaging by CT, as defined by Lugano classification.
Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.
Participant has received at least 1 or more prior lines of systemic therapy with one line consisting of a combination including an anti-CD20 monoclonal antibody (eg, rituximab, obinutuzumab) and an alkylating agent (eg, cyclophosphamide, bendamustine). Prior treatment with radiation therapy does not count as a line of therapy for eligibility.
Lab parameters:
i) Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L), ii) PLT count ≥ 75,000 cells/mm3 (75 x 109 /L) iii) Hb ≥ 7.5 g/dL
estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m².
Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN). In case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤ 5.0× ULN.
Serum total bilirubin ≤ 1.5 × ULN (corresponding to mild dysfunction as per National Cancer Institute Organ Dysfunction Working Group [NCI ODWG] criteria). In case of documented liver involvement by lymphoma, serum total bilirubin must be ≤ 3.0 × ULN (corresponding to moderate dysfunction as per NCI ODWG criteria). For cases of Gilberts syndrome, serum total bilirubin≤ 5.0 × ULN.
Adequate cardiac function for participants receiving anthracycline-based chemotherapy, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) as standard of care or multi-gated acquisition scan (MUGA).

Exclusion Criteria:

Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL or of transformed Non-Hodgkin Lymphoma (NHL), including history of prior large B-cell lymphomas (LBCL), or any other indolent lymphoma.
Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal-type FL.
Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from compliantly participating in the study based on Investigator's judgment.
Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or Sponsor's judgment.
Presence or history of central nervous system (CNS) involvement by lymphoma.
History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
Deep venous thrombosis/Pulmonary embolism within 1 month prior to enrollment.
Participants with a history of progressive multifocal leukoencephalopathy.
Participant has any other subtype of lymphoma.
Participant has persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.
History of another primary malignancy that has not been in remission for ≥ 3 years except for non-invasive malignancies.
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: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Golcadomide + Rituximab	Drug: Rituximab Specified dose on specified days Drug: Golcadomide Specified dose on specified days Other Names: BMS-986369 CC-99282
Active Comparator: Rituximab + Lenalidomide/Chemotherapy Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine	Drug: Rituximab Specified dose on specified days Drug: Cyclophosphamide Specified dose on specified days Drug: Doxorubicin Specified dose on specified days Drug: Lenalidomide Specified dose on specified days Drug: Bendamustine Specified dose on specified days Drug: Vincristine Specified dose on specified days Drug: Prednisone/Prednisolone Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC) Time Frame: Up to approximately 32 Months	Up to approximately 32 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall response rate (ORR) assessed by IRAC Time Frame: Up to approximately 32 Months	Up to approximately 32 Months
Overall survival (OS) Time Frame: Up to approximately 83 Months	Up to approximately 83 Months
PFS as assessed by investigator Time Frame: Up to approximately 32 Months	Up to approximately 32 Months
ORR as assessed by investigator Time Frame: Up to approximately 32 Months	Up to approximately 32 Months
Number of participants who achieve complete metabolic response (CMR) Time Frame: Up to approximately 32 Months	Up to approximately 32 Months
Duration of Response (DoR) Time Frame: Up to approximately 32 Months	Up to approximately 32 Months
Event free survival (EFS) Time Frame: Up to approximately 32 Months	Up to approximately 32 Months
Time to next anti-lymphoma treatment (TTNT) Time Frame: Up to approximately 32 Months	Up to approximately 32 Months
PFS on next anti-lymphoma treatment (PFS2) Time Frame: Up to approximately 32 Months	Up to approximately 32 Months
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 32 Months	Up to approximately 32 Months
Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Non- Hodgkin Lymphoma- Low Grade- 20 items (EORTC QLQNHL- LG20) Questionnaire Time Frame: Up to approximately 32 Months	Up to approximately 32 Months
Minimal residual disease (MRD) negativity Time Frame: Up to approximately 32 Months	Up to approximately 32 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)

July 28, 2025

Primary Completion (Estimated)

April 24, 2028

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CA073-1003
2024-519152-82 (Other Identifier: EU CTR)
U1111-1314-3909 (Other Identifier: WHO)

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/disclosurecommitment.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

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Follicular Lymphoma

Clinical Trials on Rituximab

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