← Back to searchRecruitingRecruiting
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)
NCT06911502 · Celgene
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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.
Eligibility criteria
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:
1. Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.
2. 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:
1. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L),
2. PLT count ≥ 75,000 cells/mm3 (75 x 109 /L)
3. 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) 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 design
Enrollment target: 400 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-28
Estimated completion: 2030-07-31
Last updated: 2025-12-05
Interventions
Drug: GolcadomideDrug: RituximabDrug: LenalidomideDrug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: Prednisone/PrednisoloneDrug: Bendamustine
Primary outcomes
- • Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC) (Up to approximately 32 Months)
Sponsor
Celgene · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 8559073286
ContactFirst line of the email MUST contain the NCT# and Site #. · contact
InvestigatorBristol Myers Squibb · study_director, Bristol-Myers Squibb
All locations (160)
Local Institution - 0225Not Yet Recruiting
Birmingham, Alabama, United States
Infirmary Cancer CareRecruiting
Mobile, Alabama, United States
Alaska Oncology and HematologyRecruiting
Anchorage, Alaska, United States
Local Institution - 0215Not Yet Recruiting
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer CenterRecruiting
Duarte, California, United States
UCSF Helen Diller Medical Center at Parnassus HeightsRecruiting
San Francisco, California, United States
Local Institution - 0008Not Yet Recruiting
Jacksonville, Florida, United States
Local Institution - 0214Not Yet Recruiting
Tampa, Florida, United States
Local Institution - 0217Not Yet Recruiting
Tampa, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalRecruiting
Marietta, Georgia, United States
Southeastern Regional Medical CenterRecruiting
Newnan, Georgia, United States
Local Institution - 0240Not Yet Recruiting
Arlington Heights, Illinois, United States
Local Institution - 0253Not Yet Recruiting
Iowa City, Iowa, United States
Local Institution - 0243Not Yet Recruiting
Waukee, Iowa, United States
Local Institution - 0216Not Yet Recruiting
Westwood, Kansas, United States
Local Institution - 0218Not Yet Recruiting
Lexington, Kentucky, United States
Local Institution - 0023Not Yet Recruiting
Baltimore, Maryland, United States
Greater Baltimore Medical CenterRecruiting
Towson, Maryland, United States
Local Institution - 0145Not Yet Recruiting
Boston, Massachusetts, United States
Local Institution - 0244Not Yet Recruiting
Boston, Massachusetts, United States
Local Institution - 0247Not Yet Recruiting
Boston, Massachusetts, United States
Hattiesburg Clinic Hematology/OncologyRecruiting
Hattiesburg, Mississippi, United States
Local Institution - 0144Not Yet Recruiting
Providence, Rhode Island, United States
Texas Oncology - Central/South TexasRecruiting
Austin, Texas, United States
Local Institution - 0212Not Yet Recruiting
Fort Worth, Texas, United States
Local Institution - 0230Not Yet Recruiting
San Antonio, Texas, United States
Texas Oncology - Northeast TexasRecruiting
Tyler, Texas, United States
Local Institution - 0238Not Yet Recruiting
Fairfax, Virginia, United States
Hematology Oncology Associates of FredericksburgRecruiting
Fredericksburg, Virginia, United States
Blue Ridge Cancer CareRecruiting
Roanoke, Virginia, United States
Local Institution - 0143Not Yet Recruiting
Vancouver, Washington, United States
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Local Institution - 0132Not Yet Recruiting
Adelaide, South Australia, Australia
Local Institution - 0131Not Yet Recruiting
Hobart, Tasmania, Australia
Local Institution - 0128Not Yet Recruiting
Heidelberg, Victoria, Australia
Cabrini Hospital - MalvernRecruiting
Malvern, Victoria, Australia
Local Institution - 0127Not Yet Recruiting
Perth, Western Australia, Australia
Local Institution - 0224Withdrawn
Perth, Western Australia, Australia
Local Institution - 0159Not Yet Recruiting
Vitória, Espírito Santo, Brazil
Local Institution - 0088Not Yet Recruiting
Niterói, Rio de Janeiro, Brazil
Local Institution - 0087Not Yet Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0079Not Yet Recruiting
São Paulo, São Paulo, Brazil
Local Institution - 0089Not Yet Recruiting
Rio de Janeiro, Brazil
Local Institution - 0066Not Yet Recruiting
São Paulo, Brazil
Local Institution - 0092Not Yet Recruiting
São Paulo, Brazil
Local Institution - 0200Not Yet Recruiting
Victoria, British Columbia, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Local Institution - 0250Not Yet Recruiting
Québec, Quebec, Canada
Local Institution - 0192Not Yet Recruiting
Sherbrooke, Quebec, Canada
Local Institution - 0226Withdrawn
Sherbrooke, Quebec, Canada
Local Institution - 0154Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0155Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0153Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 0246Not Yet Recruiting
Beijing, Beijing Municipality, China
Beijing Cancer hospitalRecruiting
Beijing, Beijing Municipality, China
Local Institution - 0172Not Yet Recruiting
Fuzhou Fujian, Fujian, China
Sun Yat-sen University Cancer CenterRecruiting
Guangzhou, Guangdong, China
Local Institution - 0241Not Yet Recruiting
Harbin, Heilongjiang, China
Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
Local Institution - 0175Not Yet Recruiting
Changsha, Hunan, China
Inner Mongolia Cancer HospitalRecruiting
Hohhot, Inner Mongolia, China
Local Institution - 0233Not Yet Recruiting
Suzhou, Jiangsu, China
Local Institution - 0178Not Yet Recruiting
Nanchang, Jiangxi, China
Local Institution - 0239Not Yet Recruiting
Changchun, Jilin, China
Local Institution - 0177Not Yet Recruiting
Changchun, Jilin, China
Local Institution - 0179Not Yet Recruiting
Shenyang, Liaoning, China
Local Institution - 0242Not Yet Recruiting
Shenyang, Liaoning, China
Shandong Cancer HospitalRecruiting
Jinan, Shandong, China
Local Institution - 0181Not Yet Recruiting
Shanghai, Shanghai Municipality, China
Local Institution - 0249Not Yet Recruiting
Shanghai, Shanghai Municipality, China
Local Institution - 0234Not Yet Recruiting
Sichuan, Sichuan, China
Local Institution - 0182Not Yet Recruiting
Tianjin, Tianjin Municipality, China
Tianjin People' s HospitalRecruiting
Tianjin, Tianjin Municipality, China
Local Institution - 0248Not Yet Recruiting
Kunming, Yunnan, China
Local Institution - 0184Not Yet Recruiting
Hangzhou, Zhejiang, China
Local Institution - 0174Not Yet Recruiting
Zhengzhou, China
Local Institution - 0151Not Yet Recruiting
Oulu, North Ostrobothnia, Finland
Local Institution - 0152Not Yet Recruiting
Turku, Southwest Finland, Finland
Local Institution - 0150Not Yet Recruiting
Helsinki, Finland
CHU Bordeaux Haut-LevequeRecruiting
Pessac, Aquitaine, France
Local Institution - 0044Not Yet Recruiting
Saint-Cloud, Hauts-de-Seine, France
Chu Saint EloiRecruiting
Montpellier, Languedoc-Roussillon, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting
Nantes, Loire-Atlantique, France
Hopital Claude Huriez - CHU de LilleRecruiting
Lille, Nord, France
Local Institution - 0042Not Yet Recruiting
Pierre-Bénite, Rhône, France
Local Institution - 0191Not Yet Recruiting
Paris, France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSERecruiting
Toulouse, France
Local Institution - 0163Not Yet Recruiting
Ulm, Baden-Wurttemberg, Germany
Klinikum AugsburgRecruiting
Augsburg, Bavaria, Germany
Local Institution - 0220Not Yet Recruiting
Göttingen, Lower Saxony, Germany
GEFOS Gesellschaft f. onkologische StudienRecruiting
Dortmund, North Rhine-Westphalia, Germany
Local Institution - 0193Not Yet Recruiting
Düsseldorf, North Rhine-Westphalia, Germany
Local Institution - 0231Withdrawn
Münster, North Rhine-Westphalia, Germany
Local Institution - 0232Not Yet Recruiting
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum des SaarlandesRecruiting
Homburg, Saarland, Germany
HELIOS Klinikum ErfurtRecruiting
Erfurt, Thuringia, Germany
Universitätsklinikum JenaRecruiting
Jena, Thuringia, Germany
Klinikum Chemnitz GgmbhRecruiting
Chemnitz, Germany
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, WolfRecruiting
Dresden, Germany
Local Institution - 0162Not Yet Recruiting
München, Germany
Local Institution - 0221Not Yet Recruiting
Würzburg, Germany
Local Institution - 0111Not Yet Recruiting
Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece
Evangelismos General Hospital of AthensRecruiting
Athens, Attikí, Greece
General Hospital of Athens "Laiko"Recruiting
Αthens, Attikí, Greece
Local Institution - 0110Not Yet Recruiting
Thessaloniki, Thessaloníki, Greece
Local Institution - 0197Not Yet Recruiting
Thessaloniki, Thessaloníki, Greece
Local Institution - 0108Not Yet Recruiting
Ioannina, Ípeiros, Greece
Local Institution - 0139Not Yet Recruiting
Bengaluru, Karnataka, India
Local Institution - 0141Not Yet Recruiting
Mumbai, Maharashtra, India
Local Institution - 0142Not Yet Recruiting
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0140Not Yet Recruiting
Hyderabad, Telangana, India
Local Institution - 0138Not Yet Recruiting
Hyderabad, Telangana, India
Local Institution - 0104Not Yet Recruiting
Bologna, Emilia-Romagna, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"Recruiting
Meldola, Emilia-Romagna, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria PisanaRecruiting
Pisa, Tuscany, Italy
Local Institution - 0102Not Yet Recruiting
Alessandria, Italy
Istituto Nazionale Tumori IRCCS Fondazione PascaleRecruiting
Naples, Italy
Local Institution - 0157Not Yet Recruiting
Torino, Italy
Nagoya University HospitalRecruiting
Nagoya, Aichi-ken, Japan
Aiiku HospitalRecruiting
Sapporo, Hokkaido, Japan
Japanease Red Cross Society Himeji HospitalRecruiting
Himeji, Hyōgo, Japan
Iwate Prefectural Central HospitalRecruiting
Morioka, Iwate, Japan
National Cancer Center HospitalRecruiting
Chuo-ku, Tokyo, Japan
Nihon University Itabashi HospitalRecruiting
Itabashiku, Tokyo, Japan
University of Yamanashi HospitalRecruiting
Chūō, Yamanashi, Japan
National Hospital Organization Kyushu Medical CenterRecruiting
Fukuoka, Japan
Kyushu University HospitalRecruiting
Fukuoka, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors HospitalRecruiting
Hiroshima, Japan
Amsterdam UMC, locatie VUmcRecruiting
Amsterdam, North Holland, Netherlands
Local Institution - 0046Not Yet Recruiting
Groningen, Netherlands
Universitair Medisch Centrum UtrechtRecruiting
Utrecht, Netherlands
AIDPORT Sp. z o.o.Recruiting
Skórzewo, Greater Poland Voivodeship, Poland
Pratia MCM KrakowRecruiting
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w WarszawieRecruiting
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0190Not Yet Recruiting
Gdynia, Pomeranian Voivodeship, Poland
Local Institution - 0189Not Yet Recruiting
Lodz, Łódź Voivodeship, Poland
Local Institution - 0099Not Yet Recruiting
Dammam, Eastern Province, Saudi Arabia
Local Institution - 0054Not Yet Recruiting
Riyadh, Saudi Arabia
Local Institution - 0052Not Yet Recruiting
Riyadh, Saudi Arabia
Local Institution - 0059Not Yet Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0060Not Yet Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0061Not Yet Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0058Not Yet Recruiting
Seoul, South Korea
Hospital Universitari Parc TauliRecruiting
Sabadell, Barcelona [Barcelona], Spain
Hospital Universitario Marqués de ValdecillaRecruiting
Santander, Cantabria, Spain
Hospital Universitario Infanta LeonorRecruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Clinico de ValenciaRecruiting
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Virgen NievesRecruiting
Granada, Spain
Local Institution - 0123Not Yet Recruiting
Madrid, Spain
Local Institution - 0195Not Yet Recruiting
Istanbul- Fatih, Istanbul, Turkey (Türkiye)
Local Institution - 0194Not Yet Recruiting
Ankara, Turkey (Türkiye)
Local Institution - 0196Not Yet Recruiting
Antalya, Turkey (Türkiye)
Local Institution - 0223Not Yet Recruiting
Mersin, Turkey (Türkiye)
Local Institution - 0251Not Yet Recruiting
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Local Institution - 0252Not Yet Recruiting
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Norfolk and Norwich University Hospitals NHS Foundation TrustRecruiting
Cringleford, England, United Kingdom
Kent and Canterbury HospitalRecruiting
Canterbury, Kent, United Kingdom
Local Institution - 0213Not Yet Recruiting
London, London, City of, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, United Kingdom