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NCT06911502PHASE3Recruiting

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)

Celgene

Start Date

7/28/2025

Completion Date

7/31/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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: i) Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy. ii) 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: i) 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). Exclusion Criteria: * 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. * 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.

Interventions

DRUG

Golcadomide

DRUG

Rituximab

DRUG

Lenalidomide

DRUG

Cyclophosphamide

DRUG

Doxorubicin

DRUG

Vincristine

DRUG

Prednisone/Prednisolone

DRUG

Bendamustine

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Conditions

Follicular Lymphoma

Locations

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