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)
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
3 other identifiers
interventional
400
21 countries
160
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2025
Longer than P75 for phase_3
160 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2025
CompletedFirst Posted
Study publicly available on registry
April 4, 2025
CompletedStudy Start
First participant enrolled
July 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
December 5, 2025
December 1, 2025
2.7 years
March 28, 2025
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)
Up to approximately 32 Months
Secondary Outcomes (12)
Overall response rate (ORR) assessed by IRAC
Up to approximately 32 Months
Overall survival (OS)
Up to approximately 83 Months
PFS as assessed by investigator
Up to approximately 32 Months
ORR as assessed by investigator
Up to approximately 32 Months
Number of participants who achieve complete metabolic response (CMR)
Up to approximately 32 Months
- +7 more secondary outcomes
Study Arms (2)
Golcadomide + Rituximab
EXPERIMENTALRituximab + Lenalidomide/Chemotherapy
ACTIVE COMPARATORRituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine
Interventions
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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:
- Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.
- 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:
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L),
- PLT count ≥ 75,000 cells/mm3 (75 x 109 /L)
- 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
- +1 more criteria
You may not qualify if:
- Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL or of transformed Non-Hodgkin Lymphoma (NHL) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (160)
Local Institution - 0225
Birmingham, Alabama, 35205, United States
Infirmary Cancer Care
Mobile, Alabama, 36607, United States
Alaska Oncology and Hematology
Anchorage, Alaska, 99508, United States
Local Institution - 0215
Little Rock, Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143, United States
Local Institution - 0008
Jacksonville, Florida, 32256, United States
Local Institution - 0214
Tampa, Florida, 33606, United States
Local Institution - 0217
Tampa, Florida, 33612, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060, United States
Southeastern Regional Medical Center
Newnan, Georgia, 30265, United States
Local Institution - 0240
Arlington Heights, Illinois, 60005, United States
Local Institution - 0253
Iowa City, Iowa, 52242, United States
Local Institution - 0243
Waukee, Iowa, 50309, United States
Local Institution - 0216
Westwood, Kansas, 66205, United States
Local Institution - 0218
Lexington, Kentucky, 40536, United States
Local Institution - 0023
Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center
Towson, Maryland, 21204, United States
Local Institution - 0145
Boston, Massachusetts, 02114, United States
Local Institution - 0244
Boston, Massachusetts, 02215, United States
Local Institution - 0247
Boston, Massachusetts, 02215, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401-7233, United States
Local Institution - 0144
Providence, Rhode Island, 02903, United States
Texas Oncology - Central/South Texas
Austin, Texas, 78705, United States
Local Institution - 0212
Fort Worth, Texas, 76104, United States
Local Institution - 0230
San Antonio, Texas, 78240, United States
Texas Oncology - Northeast Texas
Tyler, Texas, 75702, United States
Local Institution - 0238
Fairfax, Virginia, 22304, United States
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, 22408, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Local Institution - 0143
Vancouver, Washington, 98684, United States
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Local Institution - 0132
Adelaide, South Australia, 5042, Australia
Local Institution - 0131
Hobart, Tasmania, 7000, Australia
Local Institution - 0128
Heidelberg, Victoria, 3084, Australia
Cabrini Hospital - Malvern
Malvern, Victoria, 3144, Australia
Local Institution - 0127
Perth, Western Australia, 6000, Australia
Local Institution - 0224
Perth, Western Australia, 6000, Australia
Local Institution - 0159
Vitória, Espírito Santo, 29041-295, Brazil
Local Institution - 0088
Niterói, Rio de Janeiro, 24220-070, Brazil
Local Institution - 0087
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Local Institution - 0079
São Paulo, São Paulo, 04543-000, Brazil
Local Institution - 0089
Rio de Janeiro, 22250-905, Brazil
Local Institution - 0066
São Paulo, 01246-000, Brazil
Local Institution - 0092
São Paulo, 05652-900, Brazil
Local Institution - 0200
Victoria, British Columbia, V8R 6V5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Local Institution - 0250
Québec, Quebec, G1J 1Z4, Canada
Local Institution - 0192
Sherbrooke, Quebec, J1H 5N4, Canada
Local Institution - 0226
Sherbrooke, Quebec, J1H 5N4, Canada
Local Institution - 0154
Santiago, Santiago Metropolitan, 7580206, Chile
Local Institution - 0155
Santiago, Santiago Metropolitan, 8320325, Chile
Local Institution - 0153
Santiago, Santiago Metropolitan, 8420383, Chile
Local Institution - 0246
Beijing, Beijing Municipality, 100038, China
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142, China
Local Institution - 0172
Fuzhou Fujian, Fujian, 350001, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Local Institution - 0241
Harbin, Heilongjiang, 150081, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Local Institution - 0175
Changsha, Hunan, 410008, China
Inner Mongolia Cancer Hospital
Hohhot, Inner Mongolia, 010020, China
Local Institution - 0233
Suzhou, Jiangsu, 215006, China
Local Institution - 0178
Nanchang, Jiangxi, 330006, China
Local Institution - 0239
Changchun, Jilin, 130000, China
Local Institution - 0177
Changchun, Jilin, 130021, China
Local Institution - 0179
Shenyang, Liaoning, 110004, China
Local Institution - 0242
Shenyang, Liaoning, 110042, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Local Institution - 0181
Shanghai, Shanghai Municipality, 200032, China
Local Institution - 0249
Shanghai, Shanghai Municipality, 200065, China
Local Institution - 0234
Sichuan, Sichuan, 646000, China
Local Institution - 0182
Tianjin, Tianjin Municipality, 300060, China
Tianjin People' s Hospital
Tianjin, Tianjin Municipality, 300121, China
Local Institution - 0248
Kunming, Yunnan, 650118, China
Local Institution - 0184
Hangzhou, Zhejiang, 310022, China
Local Institution - 0174
Zhengzhou, 450008, China
Local Institution - 0151
Oulu, North Ostrobothnia, 90220, Finland
Local Institution - 0152
Turku, Southwest Finland, 20521, Finland
Local Institution - 0150
Helsinki, 00029, Finland
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33600, France
Local Institution - 0044
Saint-Cloud, Hauts-de-Seine, 92210, France
Chu Saint Eloi
Montpellier, Languedoc-Roussillon, 34295, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, 44093 Cedex 1, France
Hopital Claude Huriez - CHU de Lille
Lille, Nord, 59037, France
Local Institution - 0042
Pierre-Bénite, Rhône, 69310, France
Local Institution - 0191
Paris, 75010, France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, 31100, France
Local Institution - 0163
Ulm, Baden-Wurttemberg, 89081, Germany
Klinikum Augsburg
Augsburg, Bavaria, 86156, Germany
Local Institution - 0220
Göttingen, Lower Saxony, 37075, Germany
GEFOS Gesellschaft f. onkologische Studien
Dortmund, North Rhine-Westphalia, 44263, Germany
Local Institution - 0193
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Local Institution - 0231
Münster, North Rhine-Westphalia, 48153, Germany
Local Institution - 0232
Münster, North Rhine-Westphalia, 48153, Germany
Universitaetsklinikum des Saarlandes
Homburg, Saarland, 66424, Germany
HELIOS Klinikum Erfurt
Erfurt, Thuringia, 99089, Germany
Universitätsklinikum Jena
Jena, Thuringia, 07747, Germany
Klinikum Chemnitz Ggmbh
Chemnitz, 09116, Germany
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden, 01307, Germany
Local Institution - 0162
München, 81337, Germany
Local Institution - 0221
Würzburg, 97080, Germany
Local Institution - 0111
Alexandroupoli, Anatolikí Makedonía Kai Thráki, 681 00, Greece
Evangelismos General Hospital of Athens
Athens, Attikí, 106 76, Greece
General Hospital of Athens "Laiko"
Αthens, Attikí, 11526, Greece
Local Institution - 0110
Thessaloniki, Thessaloníki, 570 10, Greece
Local Institution - 0197
Thessaloniki, Thessaloníki, 570 10, Greece
Local Institution - 0108
Ioannina, Ípeiros, 455 00, Greece
Local Institution - 0139
Bengaluru, Karnataka, 560099, India
Local Institution - 0141
Mumbai, Maharashtra, 400 057, India
Local Institution - 0142
New Delhi, National Capital Territory of Delhi, 110029, India
Local Institution - 0140
Hyderabad, Telangana, 500033, India
Local Institution - 0138
Hyderabad, Telangana, 500082, India
Local Institution - 0104
Bologna, Emilia-Romagna, 40138, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, 47014, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126, Italy
Local Institution - 0102
Alessandria, 15121, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131, Italy
Local Institution - 0157
Torino, 10126, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Aiiku Hospital
Sapporo, Hokkaido, 064-0804, Japan
Japanease Red Cross Society Himeji Hospital
Himeji, Hyōgo, 670-8540, Japan
Iwate Prefectural Central Hospital
Morioka, Iwate, 020-0066, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Nihon University Itabashi Hospital
Itabashiku, Tokyo, 173-8610, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, 730-0052, Japan
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, 1081 HV, Netherlands
Local Institution - 0046
Groningen, 9713 GZ, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
AIDPORT Sp. z o.o.
Skórzewo, Greater Poland Voivodeship, 60-185, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship, 02-781, Poland
Local Institution - 0190
Gdynia, Pomeranian Voivodeship, 81-519, Poland
Local Institution - 0189
Lodz, Łódź Voivodeship, 93-513, Poland
Local Institution - 0099
Dammam, Eastern Province, 31444, Saudi Arabia
Local Institution - 0054
Riyadh, 11426, Saudi Arabia
Local Institution - 0052
Riyadh, 12713, Saudi Arabia
Local Institution - 0059
Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Local Institution - 0060
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Local Institution - 0061
Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Local Institution - 0058
Seoul, 07345, South Korea
Hospital Universitari Parc Tauli
Sabadell, Barcelona [Barcelona], 08208, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Infanta Leonor
Madrid, Madrid, Comunidad de, 28031, Spain
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010, Spain
Hospital Universitario Virgen Nieves
Granada, 18012, Spain
Local Institution - 0123
Madrid, 28040, Spain
Local Institution - 0195
Istanbul- Fatih, Istanbul, 34098, Turkey (Türkiye)
Local Institution - 0194
Ankara, 06100, Turkey (Türkiye)
Local Institution - 0196
Antalya, 07059, Turkey (Türkiye)
Local Institution - 0223
Mersin, 33343, Turkey (Türkiye)
Local Institution - 0251
Abu Dhabi, Abu Dhabi Emirate, 11001, United Arab Emirates
Local Institution - 0252
Abu Dhabi, Abu Dhabi Emirate, 92510, United Arab Emirates
Norfolk and Norwich University Hospitals NHS Foundation Trust
Cringleford, England, NR4 7UY, United Kingdom
Kent and Canterbury Hospital
Canterbury, Kent, CT1 3NG, United Kingdom
Local Institution - 0213
London, London, City of, W12 0HS, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain the NCT# and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2025
First Posted
April 4, 2025
Study Start
July 28, 2025
Primary Completion (Estimated)
April 24, 2028
Study Completion (Estimated)
July 31, 2030
Last Updated
December 5, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See 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