Follicular LymphomaPhase 3NCT06911502
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 study testing Golcadomide, Rituximab and Lenalidomide in people with Follicular Lymphoma, run by Celgene at 160 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Golcadomide, Rituximab and Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 160 sitesin 21 countries
- Study dates
- 28 Jul 2025to 31 Jul 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- 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), 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
160 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain the NCT# and Site #. contact
160 sites in 21 countries
United States31 sites, 31 recruiting
- Recruiting
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
Steven Liu, Site 0074, 907-257-9851
- Not yet recruiting
Local Institution - 0240
Arlington Heights, Illinois, 60005
Site 0240
- Recruiting
Texas Oncology - Central/South Texas
Austin, Texas, 78705
Jason Melear, Site 0237, 512-427-9400
- Not yet recruiting
Local Institution - 0023
Baltimore, Maryland, 21201
Site 0023
- Not yet recruiting
Local Institution - 0225
Birmingham, Alabama, 35205
Site 0225
- Not yet recruiting
Local Institution - 0145
Boston, Massachusetts, 02114
Site 0145
- Not yet recruiting
Local Institution - 0244
Boston, Massachusetts, 02215
Site 0244
- Not yet recruiting
Local Institution - 0247
Boston, Massachusetts, 02215
Site 0247
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Alex Herrera, Site 0072, 626-218-2405
- Not yet recruiting
Local Institution - 0238
Fairfax, Virginia, 22304
Site 0238
- Not yet recruiting
Local Institution - 0212
Fort Worth, Texas, 76104
Site 0212
- Recruiting
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, 22408
Christopher Vaughn, Site 0030, 540-371-0079
- Recruiting
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401-7233
John Hrom, Site 0013, 601-261-1700
- Not yet recruiting
Local Institution - 0253
Iowa City, Iowa, 52242
Site 0253
- Not yet recruiting
Local Institution - 0008
Jacksonville, Florida, 32256
Site 0008
- Not yet recruiting
Local Institution - 0218
Lexington, Kentucky, 40536
Site 0218
- Not yet recruiting
Local Institution - 0215
Little Rock, Arkansas, 72205
Site 0215
- Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
Dean Kirkel, Site 0021, 770-281-5100
- Recruiting
Infirmary Cancer Care
Mobile, Alabama, 36607
Furhan Yunus, Site 0014, 901-634-5546
- Recruiting
Southeastern Regional Medical Center
Newnan, Georgia, 30265
Sabarish Ayyappan, Site 0245, 000-000-0000
- Not yet recruiting
Local Institution - 0144
Providence, Rhode Island, 02903
Site 0144
- Recruiting
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
Amanda Gillespie-Twardy, Site 0146, 540-982-0237
- Not yet recruiting
Local Institution - 0230
San Antonio, Texas, 78240
Site 0230
- Recruiting
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143
Charalambos Andreadis, Site 0119, 415-238-1909
- Not yet recruiting
Local Institution - 0214
Tampa, Florida, 33606
Site 0214
- Not yet recruiting
Local Institution - 0217
Tampa, Florida, 33612
Site 0217
- Recruiting
Greater Baltimore Medical Center
Towson, Maryland, 21204
Zhuoyan Li, Site 0010, 443-849-3051
- Recruiting
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Habte Yimer, Site 0236, 903-579-9800
- Not yet recruiting
Local Institution - 0143
Vancouver, Washington, 98684
Site 0143
- Not yet recruiting
Local Institution - 0243
Waukee, Iowa, 50309
Site 0243
- Not yet recruiting
Local Institution - 0216
Westwood, Kansas, 66205
Site 0216
China23 sites, 23 recruiting
- Not yet recruiting
Local Institution - 0246
Beijing, Beijing Municipality, 100038
Site 0246
- Recruiting
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142
Yuqin Song, Site 0171, 13683398726
- Not yet recruiting
Local Institution - 0239
Changchun, Jilin, 130000
Site 0239
- Not yet recruiting
Local Institution - 0177
Changchun, Jilin, 130021
Site 0177
- Not yet recruiting
Local Institution - 0175
Changsha, Hunan, 410008
Site 0175
- Not yet recruiting
Local Institution - 0172
Fuzhou Fujian, Fujian, 350001
Site 0172
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhiming Li, Site 0173, +8613719189172
- Not yet recruiting
Local Institution - 0184
Hangzhou, Zhejiang, 310022
Site 0184
- Not yet recruiting
Local Institution - 0241
Harbin, Heilongjiang, 150081
Site 0241
- Recruiting
Inner Mongolia Cancer Hospital
Hohhot, Inner Mongolia, 010020
Ping Lingyan, Site 0235, 13520201279
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Zengjun Li, Site 0180, +8613642138692
- Not yet recruiting
Local Institution - 0248
Kunming, Yunnan, 650118
Site 0248
- Not yet recruiting
Local Institution - 0178
Nanchang, Jiangxi, 330006
Site 0178
- Not yet recruiting
Local Institution - 0181
Shanghai, Shanghai Municipality, 200032
Site 0181
- Not yet recruiting
Local Institution - 0249
Shanghai, Shanghai Municipality, 200065
Site 0249
- Not yet recruiting
Local Institution - 0179
Shenyang, Liaoning, 110004
Site 0179
- Not yet recruiting
Local Institution - 0242
Shenyang, Liaoning, 110042
Site 0242
- Not yet recruiting
Local Institution - 0234
Sichuan, Sichuan, 646000
Site 0234
- Not yet recruiting
Local Institution - 0233
Suzhou, Jiangsu, 215006
Site 0233
- Not yet recruiting
Local Institution - 0182
Tianjin, Tianjin Municipality, 300060
Site 0182
- Recruiting
Tianjin People' s Hospital
Tianjin, Tianjin Municipality, 300121
Xingli Zhao, Site 0227, 13752255454
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Liling Zhang, Site 0176, 15871725926
- Not yet recruiting
Local Institution - 0174
Zhengzhou, 450008
Site 0174
Germany14 sites, 13 recruiting
- Recruiting
Klinikum Augsburg
Augsburg, Bavaria, 86156
Rainer Claus, Site 0161, +491791098382
- Recruiting
Klinikum Chemnitz Ggmbh
Chemnitz, 09116
Mathias Haenel, Site 0165, 4937133344500
- Recruiting
GEFOS Gesellschaft f. onkologische Studien
Dortmund, North Rhine-Westphalia, 44263
Sandra Ketzler-Henkel, Site 0166, 02312069011
- Recruiting
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden, 01307
Thomas Illmer, Site 0187, 00493514400022
- Not yet recruiting
Local Institution - 0193
Düsseldorf, North Rhine-Westphalia, 40225
Site 0193
- Recruiting
HELIOS Klinikum Erfurt
Erfurt, Thuringia, 99089
Sebastian Scholl, Site 0222, +493617812476
- Not yet recruiting
Local Institution - 0220
Göttingen, Lower Saxony, 37075
Site 0220
- Recruiting
Universitaetsklinikum des Saarlandes
Homburg, Saarland, 66424
Konstantinos Christofyllakis, Site 0164, +68411615358
- Recruiting
Universitätsklinikum Jena
Jena, Thuringia, 07747
Ulf Schnetzke, Site 0167, 036419327113
- Not yet recruiting
Local Institution - 0162
München, 81337
Site 0162
- Withdrawn
Local Institution - 0231
Münster, North Rhine-Westphalia, 48153
- Not yet recruiting
Local Institution - 0232
Münster, North Rhine-Westphalia, 48153
Site 0232
- Not yet recruiting
Local Institution - 0163
Ulm, Baden-Wurttemberg, 89081
Site 0163
- Not yet recruiting
Local Institution - 0221
Würzburg, 97080
Site 0221
Japan10 sites, 10 recruiting
- Recruiting
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898
Ichiro Kawashima, Site 0210, 0552731111
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Suguru Fukuhara, Site 0229, 81335422511
- Recruiting
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563
Ken Takase, Site 0209, 81928520700
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
Kohta Miyawaki, Site 0208, 81926425230
- Recruiting
Japanease Red Cross Society Himeji Hospital
Himeji, Hyōgo, 670-8540
Takeru Asano, Site 0211, +81-79-294-2251
- Recruiting
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, 730-0052
Tsuyoshi Muta, Site 0204, 81822413111
- Recruiting
Nihon University Itabashi Hospital
Itabashiku, Tokyo, 173-8610
Katsuhiro Miura, Site 0207, +81-(0)3-3972-8111
- Recruiting
Iwate Prefectural Central Hospital
Morioka, Iwate, 020-0066
Kazunori Murai, Site 0201
- Recruiting
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Kazuyuki Shimada, Site 0205, 81527442141
- Recruiting
Aiiku Hospital
Sapporo, Hokkaido, 064-0804
Koh Izumiyama, Site 0202, 81115632211
France8 sites, 8 recruiting
- Recruiting
Hopital Claude Huriez - CHU de Lille
Lille, Nord, 59037
Franck Morschhauser, Site 0048, 33320445713
- Recruiting
Chu Saint Eloi
Montpellier, Languedoc-Roussillon, 34295
Guillaume Cartron, Site 0047, +33675926918
- Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, 44093 Cedex 1
Thomas Gastinne, Site 0120, 33240083271
- Not yet recruiting
Local Institution - 0191
Paris, 75010
Site 0191
- Recruiting
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33600
Francois-Xavier Gros, Site 0100, 33557656511
- Not yet recruiting
Local Institution - 0042
Pierre-Bénite, Rhône, 69310
Site 0042
- Not yet recruiting
Local Institution - 0044
Saint-Cloud, Hauts-de-Seine, 92210
Site 0044
- Recruiting
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, 31100
Loïc Ysebaert, Site 0121, 33531156351
Australia7 sites, 6 recruiting
- Not yet recruiting
Local Institution - 0132
Adelaide, South Australia, 5042
Site 0132
- Not yet recruiting
Local Institution - 0128
Heidelberg, Victoria, 3084
Site 0128
- Not yet recruiting
Local Institution - 0131
Hobart, Tasmania, 7000
Site 0131
- Recruiting
Cabrini Hospital - Malvern
Malvern, Victoria, 3144
Adrian Minson, Site 0198, 85595000
- Not yet recruiting
Local Institution - 0127
Perth, Western Australia, 6000
Site 0127
- Withdrawn
Local Institution - 0224
Perth, Western Australia, 6000
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Amanda Johnston, Site 0134, 61288906352
Brazil7 sites, 7 recruiting
- Not yet recruiting
Local Institution - 0088
Niterói, Rio de Janeiro, 24220-070
Site 0088
- Not yet recruiting
Local Institution - 0087
Porto Alegre, Rio Grande do Sul, 90110-270
Site 0087
- Not yet recruiting
Local Institution - 0089
Rio de Janeiro, 22250-905
Site 0089
- Not yet recruiting
Local Institution - 0079
São Paulo, São Paulo, 04543-000
Site 0079
- Not yet recruiting
Local Institution - 0066
São Paulo, 01246-000
Site 0066
- Not yet recruiting
Local Institution - 0092
São Paulo, 05652-900
Site 0092
- Not yet recruiting
Local Institution - 0159
Vitória, Espírito Santo, 29041-295
Site 0159
Italy7 sites, 7 recruiting
- Not yet recruiting
Local Institution - 0102
Alessandria, 15121
Site 0102
- Not yet recruiting
Local Institution - 0104
Bologna, Emilia-Romagna, 40138
Site 0104
- Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, 47014
Gerardo Musuraca, Site 0101, +390543739292
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131
Antonio Pinto, Site 0105, 390815903382
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126
Sara Galimberti, Site 0106, +393470038656
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Armando Santoro, Site 0103, 390282244080
- Not yet recruiting
Local Institution - 0157
Torino, 10126
Site 0157
Greece6 sites, 6 recruiting
- Not yet recruiting
Local Institution - 0111
Alexandroupoli, Anatolikí Makedonía Kai Thráki, 681 00
Site 0111
- Recruiting
Evangelismos General Hospital of Athens
Athens, Attikí, 106 76
Maria Bouzani, Site 0109, +302132041721
- Not yet recruiting
Local Institution - 0108
Ioannina, Ípeiros, 455 00
Site 0108
- Not yet recruiting
Local Institution - 0110
Thessaloniki, Thessaloníki, 570 10
Site 0110
- Not yet recruiting
Local Institution - 0197
Thessaloniki, Thessaloníki, 570 10
Site 0197
- Recruiting
General Hospital of Athens "Laiko"
Αthens, Attikí, 11526
Theodoros Vassilakopoulos, Site 0107, 302132061702
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitario Virgen Nieves
Granada, 18012
Jose Puerta Puerta, Site 0126, 0034958020013
- Recruiting
Hospital Universitario Infanta Leonor
Madrid, Madrid, Comunidad de, 28031
Jose Angel Hernandez Rivas, Site 0124, 34619249275
- Not yet recruiting
Local Institution - 0123
Madrid, 28040
Site 0123
- Recruiting
Hospital Universitari Parc Tauli
Sabadell, Barcelona [Barcelona], 08208
Xavier Vilaseca Creus, Site 0158, +34937231010
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Sonia Gonzalez de Villambrosia, Site 0122, 942292529Ext73188
- Recruiting
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, 46010
Blanca Ferrer Lores, Site 0125, 34963987649
Canada5 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0250
Québec, Quebec, G1J 1Z4
Site 0250
- Not yet recruiting
Local Institution - 0192
Sherbrooke, Quebec, J1H 5N4
Site 0192
- Withdrawn
Local Institution - 0226
Sherbrooke, Quebec, J1H 5N4
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Robert Kridel, Site 0035, 41694645012243
- Not yet recruiting
Local Institution - 0200
Victoria, British Columbia, V8R 6V5
Site 0200
India5 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0139
Bengaluru, Karnataka, 560099
Site 0139
- Not yet recruiting
Local Institution - 0140
Hyderabad, Telangana, 500033
Site 0140
- Not yet recruiting
Local Institution - 0138
Hyderabad, Telangana, 500082
Site 0138
- Not yet recruiting
Local Institution - 0141
Mumbai, Maharashtra, 400 057
Site 0141
- Not yet recruiting
Local Institution - 0142
New Delhi, National Capital Territory of Delhi, 110029
Site 0142
Poland5 sites, 5 recruiting
- Not yet recruiting
Local Institution - 0190
Gdynia, Pomeranian Voivodeship, 81-519
Site 0190
- Recruiting
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, 30-727
Wojciech Jurczak, Site 0186, +48602338290
- Not yet recruiting
Local Institution - 0189
Lodz, Łódź Voivodeship, 93-513
Site 0189
- Recruiting
AIDPORT Sp. z o.o.
Skórzewo, Greater Poland Voivodeship, 60-185
Michal Kwiatek, Site 0185, +48793602210
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship, 02-781
Ewa Paszkiewicz-Kozik, Site 0188, 48225462366
South Korea4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0059
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Site 0059
- Not yet recruiting
Local Institution - 0060
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Site 0060
- Not yet recruiting
Local Institution - 0061
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Site 0061
- Not yet recruiting
Local Institution - 0058
Seoul, 07345
Site 0058
Turkey (Türkiye)4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 0194
Ankara, 06100
Site 0194
- Not yet recruiting
Local Institution - 0196
Antalya, 07059
Site 0196
- Not yet recruiting
Local Institution - 0195
Istanbul- Fatih, Istanbul, 34098
Site 0195
- Not yet recruiting
Local Institution - 0223
Mersin, 33343
Site 0223
United Kingdom4 sites, 4 recruiting
- Recruiting
Kent and Canterbury Hospital
Canterbury, Kent, CT1 3NG
Moya Young, Site 0147, 01227 766877
- Recruiting
Norfolk and Norwich University Hospitals NHS Foundation Trust
Cringleford, England, NR4 7UY
Joel Cunningham, Site 0148, 01603 286286
- Not yet recruiting
Local Institution - 0213
London, London, City of, W12 0HS
Site 0213
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Kim Linton, Site 0149, 01614 463000
Chile3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0154
Santiago, Santiago Metropolitan, 7580206
Site 0154
- Not yet recruiting
Local Institution - 0155
Santiago, Santiago Metropolitan, 8320325
Site 0155
- Not yet recruiting
Local Institution - 0153
Santiago, Santiago Metropolitan, 8420383
Site 0153, +358 8 669 9500
Finland3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0150
Helsinki, 00029
Site 0150, +358 9 4711
- Not yet recruiting
Local Institution - 0151
Oulu, North Ostrobothnia, 90220
Site 0151, +358 8 669 9500
- Not yet recruiting
Local Institution - 0152
Turku, Southwest Finland, 20521
Site 0152, +358 2 3130000
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, 1081 HV
Sanne Tonino, Site 0050, +31-20-5669111
- Not yet recruiting
Local Institution - 0046
Groningen, 9713 GZ
Site 0046
- Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Margot Jak, Site 0053, +31887555878
Saudi Arabia3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0099
Dammam, Eastern Province, 31444
Site 0099
- Not yet recruiting
Local Institution - 0054
Riyadh, 11426
Site 0054
- Not yet recruiting
Local Institution - 0052
Riyadh, 12713
Site 0052
United Arab Emirates2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0251
Abu Dhabi, Abu Dhabi Emirate, 11001
Site 0251
- Not yet recruiting
Local Institution - 0252
Abu Dhabi, Abu Dhabi Emirate, 92510
Site 0252
About this study
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
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
- Follicular Lymphoma
- Being tested
- Golcadomide, Rituximab, Lenalidomide, Cyclophosphamide, Doxorubicin
- Keywords
- Follicular Lymphoma, Second Line Follicular Lymphoma, Third Line Follicular Lymphoma, Relapsed/refractory follicular lymphoma
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolcadomideDrug
Also called CC-99282, BMS-986369
Specified dose on specified days
RituximabDrug
Specified dose on specified days
LenalidomideDrug
Specified dose on specified days
CyclophosphamideDrug
Specified dose on specified days
DoxorubicinDrug
Specified dose on specified days
VincristineDrug
Specified dose on specified days
Prednisone/PrednisoloneDrug
Specified dose on specified days
BendamustineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Golcadomide + Rituximab | Experimental | Not described Receives: Drug: Golcadomide; Drug: Rituximab |
| Rituximab + Lenalidomide/Chemotherapy | Active comparator | Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine Receives: Drug: Rituximab; Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/Prednisolone; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)
Measured: Up to approximately 32 Months
Secondary outcomes (12)
Overall response rate (ORR) assessed by IRAC
Measured: Up to approximately 32 Months
Overall survival (OS)
Measured: Up to approximately 83 Months
PFS as assessed by investigator
Measured: Up to approximately 32 Months
ORR as assessed by investigator
Measured: Up to approximately 32 Months
Number of participants who achieve complete metabolic response (CMR)
Measured: Up to approximately 32 Months
Duration of Response (DoR)
Measured: Up to approximately 32 Months
Event free survival (EFS)
Measured: Up to approximately 32 Months
Time to next anti-lymphoma treatment (TTNT)
Measured: Up to approximately 32 Months
PFS on next anti-lymphoma treatment (PFS2)
Measured: 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
Measured: 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
Measured: Up to approximately 32 Months
Minimal residual disease (MRD) negativity
Measured: Up to approximately 32 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start28 Jul 2025
- Primary completion24 Apr 2028 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911502
- Sponsor's protocol ID
- CA073-1003
- Other IDs
- 2024-519152-82, U1111-1314-3909
- Status last verified
- May 2026
- First submitted
- 28 Mar 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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