Actively Recruiting
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)
Led by Celgene · Updated on 2025-12-05
400
Participants Needed
160
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed follicular lymphoma (Grade 1, 2, 3a or classic FL)
- Relapsed or refractory disease as defined by response to prior therapy
- ECOG performance status of 0 to 2 (3 allowed if due to lymphoma only)
- PET-positive disease with at least one measurable lesion on CT
- Indication for anti-lymphoma treatment per investigator assessment
- At least 1 prior line of systemic therapy including an anti-CD20 monoclonal antibody and an alkylating agent
- Absolute neutrophil count ≥ 1,000 cells/mm3
- Platelet count ≥ 75,000 cells/mm3
- Hemoglobin ≥ 7.5 g/dL
- Estimated glomerular filtration rate ≥ 30 ml/min/1.73m2
- AST/ALT ≤ 2.5 times upper limit of normal (up to 5 times if liver involved)
- Total bilirubin ≤ 1.5 times upper limit of normal (up to 3 times if liver involved; up to 5 times for Gilbert's syndrome)
- Adequate cardiac function with left ventricular ejection fraction ≥ 45%
You will not qualify if you...
- Evidence or history of diffuse large B-cell lymphoma or transformed non-Hodgkin lymphoma
- Follicular large cell lymphoma (grade 3b) or duodenal-type FL
- Significant medical condition, laboratory abnormality, or psychiatric illness preventing study participation
- Any condition that interferes with data interpretation
- Central nervous system involvement by lymphoma
- Stroke or intracranial hemorrhage within 6 months prior to enrollment
- Deep venous thrombosis or pulmonary embolism within 1 month prior to enrollment
- History of progressive multifocal leukoencephalopathy
- Any other lymphoma subtype
- Persistent diarrhea or malabsorption grade 2 or higher despite treatment
- History of other primary malignancy not in remission for at least 3 years except non-invasive malignancies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 160 locations
1
Local Institution - 0225
Birmingham, Alabama, United States, 35205
Not Yet Recruiting
2
Infirmary Cancer Care
Mobile, Alabama, United States, 36607
Actively Recruiting
3
Alaska Oncology and Hematology
Anchorage, Alaska, United States, 99508
Actively Recruiting
4
Local Institution - 0215
Little Rock, Arkansas, United States, 72205
Not Yet Recruiting
5
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
6
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States, 94143
Actively Recruiting
7
Local Institution - 0008
Jacksonville, Florida, United States, 32256
Not Yet Recruiting
8
Local Institution - 0214
Tampa, Florida, United States, 33606
Not Yet Recruiting
9
Local Institution - 0217
Tampa, Florida, United States, 33612
Not Yet Recruiting
10
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States, 30060
Actively Recruiting
11
Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
Actively Recruiting
12
Local Institution - 0240
Arlington Heights, Illinois, United States, 60005
Not Yet Recruiting
13
Local Institution - 0253
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
14
Local Institution - 0243
Waukee, Iowa, United States, 50309
Not Yet Recruiting
15
Local Institution - 0216
Westwood, Kansas, United States, 66205
Not Yet Recruiting
16
Local Institution - 0218
Lexington, Kentucky, United States, 40536
Not Yet Recruiting
17
Local Institution - 0023
Baltimore, Maryland, United States, 21201
Not Yet Recruiting
18
Greater Baltimore Medical Center
Towson, Maryland, United States, 21204
Actively Recruiting
19
Local Institution - 0145
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
20
Local Institution - 0244
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
21
Local Institution - 0247
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
22
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States, 39401-7233
Actively Recruiting
23
Local Institution - 0144
Providence, Rhode Island, United States, 02903
Not Yet Recruiting
24
Texas Oncology - Central/South Texas
Austin, Texas, United States, 78705
Actively Recruiting
25
Local Institution - 0212
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
26
Local Institution - 0230
San Antonio, Texas, United States, 78240
Not Yet Recruiting
27
Texas Oncology - Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
28
Local Institution - 0238
Fairfax, Virginia, United States, 22304
Not Yet Recruiting
29
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, United States, 22408
Actively Recruiting
30
Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Actively Recruiting
31
Local Institution - 0143
Vancouver, Washington, United States, 98684
Not Yet Recruiting
32
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
33
Local Institution - 0132
Adelaide, South Australia, Australia, 5042
Not Yet Recruiting
34
Local Institution - 0131
Hobart, Tasmania, Australia, 7000
Not Yet Recruiting
35
Local Institution - 0128
Heidelberg, Victoria, Australia, 3084
Not Yet Recruiting
36
Cabrini Hospital - Malvern
Malvern, Victoria, Australia, 3144
Actively Recruiting
37
Local Institution - 0127
Perth, Western Australia, Australia, 6000
Not Yet Recruiting
38
Local Institution - 0224
Perth, Western Australia, Australia, 6000
Withdrawn
39
Local Institution - 0159
Vitória, Espírito Santo, Brazil, 29041-295
Not Yet Recruiting
40
Local Institution - 0088
Niterói, Rio de Janeiro, Brazil, 24220-070
Not Yet Recruiting
41
Local Institution - 0087
Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
Not Yet Recruiting
42
Local Institution - 0079
São Paulo, São Paulo, Brazil, 04543-000
Not Yet Recruiting
43
Local Institution - 0089
Rio de Janeiro, Brazil, 22250-905
Not Yet Recruiting
44
Local Institution - 0066
São Paulo, Brazil, 01246-000
Not Yet Recruiting
45
Local Institution - 0092
São Paulo, Brazil, 05652-900
Not Yet Recruiting
46
Local Institution - 0200
Victoria, British Columbia, Canada, V8R 6V5
Not Yet Recruiting
47
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
48
Local Institution - 0250
Québec, Quebec, Canada, G1J 1Z4
Not Yet Recruiting
49
Local Institution - 0192
Sherbrooke, Quebec, Canada, J1H 5N4
Not Yet Recruiting
50
Local Institution - 0226
Sherbrooke, Quebec, Canada, J1H 5N4
Withdrawn
51
Local Institution - 0154
Santiago, Santiago Metropolitan, Chile, 7580206
Not Yet Recruiting
52
Local Institution - 0155
Santiago, Santiago Metropolitan, Chile, 8320325
Not Yet Recruiting
53
Local Institution - 0153
Santiago, Santiago Metropolitan, Chile, 8420383
Not Yet Recruiting
54
Local Institution - 0246
Beijing, Beijing Municipality, China, 100038
Not Yet Recruiting
55
Beijing Cancer hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
56
Local Institution - 0172
Fuzhou Fujian, Fujian, China, 350001
Not Yet Recruiting
57
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
58
Local Institution - 0241
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
59
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
60
Local Institution - 0175
Changsha, Hunan, China, 410008
Not Yet Recruiting
61
Inner Mongolia Cancer Hospital
Hohhot, Inner Mongolia, China, 010020
Actively Recruiting
62
Local Institution - 0233
Suzhou, Jiangsu, China, 215006
Not Yet Recruiting
63
Local Institution - 0178
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
64
Local Institution - 0239
Changchun, Jilin, China, 130000
Not Yet Recruiting
65
Local Institution - 0177
Changchun, Jilin, China, 130021
Not Yet Recruiting
66
Local Institution - 0179
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
67
Local Institution - 0242
Shenyang, Liaoning, China, 110042
Not Yet Recruiting
68
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
69
Local Institution - 0181
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
70
Local Institution - 0249
Shanghai, Shanghai Municipality, China, 200065
Not Yet Recruiting
71
Local Institution - 0234
Sichuan, Sichuan, China, 646000
Not Yet Recruiting
72
Local Institution - 0182
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
73
Tianjin People' s Hospital
Tianjin, Tianjin Municipality, China, 300121
Actively Recruiting
74
Local Institution - 0248
Kunming, Yunnan, China, 650118
Not Yet Recruiting
75
Local Institution - 0184
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
76
Local Institution - 0174
Zhengzhou, China, 450008
Not Yet Recruiting
77
Local Institution - 0151
Oulu, North Ostrobothnia, Finland, 90220
Not Yet Recruiting
78
Local Institution - 0152
Turku, Southwest Finland, Finland, 20521
Not Yet Recruiting
79
Local Institution - 0150
Helsinki, Finland, 00029
Not Yet Recruiting
80
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, France, 33600
Actively Recruiting
81
Local Institution - 0044
Saint-Cloud, Hauts-de-Seine, France, 92210
Not Yet Recruiting
82
Chu Saint Eloi
Montpellier, Languedoc-Roussillon, France, 34295
Actively Recruiting
83
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, France, 44093 Cedex 1
Actively Recruiting
84
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France, 59037
Actively Recruiting
85
Local Institution - 0042
Pierre-Bénite, Rhône, France, 69310
Not Yet Recruiting
86
Local Institution - 0191
Paris, France, 75010
Not Yet Recruiting
87
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, France, 31100
Actively Recruiting
88
Local Institution - 0163
Ulm, Baden-Wurttemberg, Germany, 89081
Not Yet Recruiting
89
Klinikum Augsburg
Augsburg, Bavaria, Germany, 86156
Actively Recruiting
90
Local Institution - 0220
Göttingen, Lower Saxony, Germany, 37075
Not Yet Recruiting
91
GEFOS Gesellschaft f. onkologische Studien
Dortmund, North Rhine-Westphalia, Germany, 44263
Actively Recruiting
92
Local Institution - 0193
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Not Yet Recruiting
93
Local Institution - 0231
Münster, North Rhine-Westphalia, Germany, 48153
Withdrawn
94
Local Institution - 0232
Münster, North Rhine-Westphalia, Germany, 48153
Not Yet Recruiting
95
Universitaetsklinikum des Saarlandes
Homburg, Saarland, Germany, 66424
Actively Recruiting
96
HELIOS Klinikum Erfurt
Erfurt, Thuringia, Germany, 99089
Actively Recruiting
97
Universitätsklinikum Jena
Jena, Thuringia, Germany, 07747
Actively Recruiting
98
Klinikum Chemnitz Ggmbh
Chemnitz, Germany, 09116
Actively Recruiting
99
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden, Germany, 01307
Actively Recruiting
100
Local Institution - 0162
München, Germany, 81337
Not Yet Recruiting
101
Local Institution - 0221
Würzburg, Germany, 97080
Not Yet Recruiting
102
Local Institution - 0111
Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece, 681 00
Not Yet Recruiting
103
Evangelismos General Hospital of Athens
Athens, Attikí, Greece, 106 76
Actively Recruiting
104
General Hospital of Athens "Laiko"
Αthens, Attikí, Greece, 11526
Actively Recruiting
105
Local Institution - 0110
Thessaloniki, Thessaloníki, Greece, 570 10
Not Yet Recruiting
106
Local Institution - 0197
Thessaloniki, Thessaloníki, Greece, 570 10
Not Yet Recruiting
107
Local Institution - 0108
Ioannina, Ípeiros, Greece, 455 00
Not Yet Recruiting
108
Local Institution - 0139
Bengaluru, Karnataka, India, 560099
Not Yet Recruiting
109
Local Institution - 0141
Mumbai, Maharashtra, India, 400 057
Not Yet Recruiting
110
Local Institution - 0142
New Delhi, National Capital Territory of Delhi, India, 110029
Not Yet Recruiting
111
Local Institution - 0140
Hyderabad, Telangana, India, 500033
Not Yet Recruiting
112
Local Institution - 0138
Hyderabad, Telangana, India, 500082
Not Yet Recruiting
113
Local Institution - 0104
Bologna, Emilia-Romagna, Italy, 40138
Not Yet Recruiting
114
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, Italy, 47014
Actively Recruiting
115
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Actively Recruiting
116
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy, 56126
Actively Recruiting
117
Local Institution - 0102
Alessandria, Italy, 15121
Not Yet Recruiting
118
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Italy, 80131
Actively Recruiting
119
Local Institution - 0157
Torino, Italy, 10126
Not Yet Recruiting
120
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 466-8560
Actively Recruiting
121
Aiiku Hospital
Sapporo, Hokkaido, Japan, 064-0804
Actively Recruiting
122
Japanease Red Cross Society Himeji Hospital
Himeji, Hyōgo, Japan, 670-8540
Actively Recruiting
123
Iwate Prefectural Central Hospital
Morioka, Iwate, Japan, 020-0066
Actively Recruiting
124
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
125
Nihon University Itabashi Hospital
Itabashiku, Tokyo, Japan, 173-8610
Actively Recruiting
126
University of Yamanashi Hospital
Chūō, Yamanashi, Japan, 409-3898
Actively Recruiting
127
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan, 810-8563
Actively Recruiting
128
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Actively Recruiting
129
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Japan, 730-0052
Actively Recruiting
130
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
131
Local Institution - 0046
Groningen, Netherlands, 9713 GZ
Not Yet Recruiting
132
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
133
AIDPORT Sp. z o.o.
Skórzewo, Greater Poland Voivodeship, Poland, 60-185
Actively Recruiting
134
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, Poland, 30-727
Actively Recruiting
135
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
136
Local Institution - 0190
Gdynia, Pomeranian Voivodeship, Poland, 81-519
Not Yet Recruiting
137
Local Institution - 0189
Lodz, Łódź Voivodeship, Poland, 93-513
Not Yet Recruiting
138
Local Institution - 0099
Dammam, Eastern Province, Saudi Arabia, 31444
Not Yet Recruiting
139
Local Institution - 0054
Riyadh, Saudi Arabia, 11426
Not Yet Recruiting
140
Local Institution - 0052
Riyadh, Saudi Arabia, 12713
Not Yet Recruiting
141
Local Institution - 0059
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
Not Yet Recruiting
142
Local Institution - 0060
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
Not Yet Recruiting
143
Local Institution - 0061
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
Not Yet Recruiting
144
Local Institution - 0058
Seoul, South Korea, 07345
Not Yet Recruiting
145
Hospital Universitari Parc Tauli
Sabadell, Barcelona [Barcelona], Spain, 08208
Actively Recruiting
146
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
147
Hospital Universitario Infanta Leonor
Madrid, Madrid, Comunidad de, Spain, 28031
Actively Recruiting
148
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, Spain, 46010
Actively Recruiting
149
Hospital Universitario Virgen Nieves
Granada, Spain, 18012
Actively Recruiting
150
Local Institution - 0123
Madrid, Spain, 28040
Not Yet Recruiting
151
Local Institution - 0195
Istanbul- Fatih, Istanbul, Turkey (Türkiye), 34098
Not Yet Recruiting
152
Local Institution - 0194
Ankara, Turkey (Türkiye), 06100
Not Yet Recruiting
153
Local Institution - 0196
Antalya, Turkey (Türkiye), 07059
Not Yet Recruiting
154
Local Institution - 0223
Mersin, Turkey (Türkiye), 33343
Not Yet Recruiting
155
Local Institution - 0251
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 11001
Not Yet Recruiting
156
Local Institution - 0252
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 92510
Not Yet Recruiting
157
Norfolk and Norwich University Hospitals NHS Foundation Trust
Cringleford, England, United Kingdom, NR4 7UY
Actively Recruiting
158
Kent and Canterbury Hospital
Canterbury, Kent, United Kingdom, CT1 3NG
Actively Recruiting
159
Local Institution - 0213
London, London, City of, United Kingdom, W12 0HS
Not Yet Recruiting
160
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain the NCT# and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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