Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06911502

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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%
Not Eligible

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

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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

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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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