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RECRUITING

NCT06911502

PHASE3

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)

Sponsor: Celgene

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-07-28

Completion Date

2030-07-31

Last Updated

2025-12-05

Healthy Volunteers

No

Conditions

Follicular Lymphoma

Interventions

DRUG

Golcadomide

Specified dose on specified days

DRUG

Rituximab

Specified dose on specified days

DRUG

Lenalidomide

Specified dose on specified days

DRUG

Cyclophosphamide

Specified dose on specified days

DRUG

Doxorubicin

Specified dose on specified days

DRUG

Vincristine

Specified dose on specified days

DRUG

Prednisone/Prednisolone

Specified dose on specified days

DRUG

Bendamustine

Specified dose on specified days

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.

Locations (160)

Local Institution - 0225

Birmingham, Alabama, United States

Infirmary Cancer Care

Mobile, Alabama, United States

Alaska Oncology and Hematology

Anchorage, Alaska, United States

Local Institution - 0215

Little Rock, Arkansas, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, United States

Local Institution - 0008

Jacksonville, Florida, United States

Local Institution - 0214

Tampa, Florida, United States

Local Institution - 0217

Tampa, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, United States

Southeastern Regional Medical Center

Newnan, Georgia, United States

Local Institution - 0240

Arlington Heights, Illinois, United States

Local Institution - 0253

Iowa City, Iowa, United States

Local Institution - 0243

Waukee, Iowa, United States

Local Institution - 0216

Westwood, Kansas, United States

Local Institution - 0218

Lexington, Kentucky, United States

Local Institution - 0023

Baltimore, Maryland, United States

Greater Baltimore Medical Center

Towson, Maryland, United States

Local Institution - 0145

Boston, Massachusetts, United States

Local Institution - 0244

Boston, Massachusetts, United States

Local Institution - 0247

Boston, Massachusetts, United States

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, United States

Local Institution - 0144

Providence, Rhode Island, United States

Texas Oncology - Central/South Texas

Austin, Texas, United States

Local Institution - 0212

Fort Worth, Texas, United States

Local Institution - 0230

San Antonio, Texas, United States

Texas Oncology - Northeast Texas

Tyler, Texas, United States

Local Institution - 0238

Fairfax, Virginia, United States

Hematology Oncology Associates of Fredericksburg

Fredericksburg, Virginia, United States

Blue Ridge Cancer Care

Roanoke, Virginia, United States

Local Institution - 0143

Vancouver, Washington, United States

Westmead Hospital

Westmead, New South Wales, Australia

Local Institution - 0132

Adelaide, South Australia, Australia

Local Institution - 0131

Hobart, Tasmania, Australia

Local Institution - 0128

Heidelberg, Victoria, Australia

Cabrini Hospital - Malvern

Malvern, Victoria, Australia

Local Institution - 0127

Perth, Western Australia, Australia

Local Institution - 0224

Perth, Western Australia, Australia

Local Institution - 0159

Vitória, Espírito Santo, Brazil

Local Institution - 0088

Niterói, Rio de Janeiro, Brazil

Local Institution - 0087

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0079

São Paulo, São Paulo, Brazil

Local Institution - 0089

Rio de Janeiro, Brazil

Local Institution - 0066

São Paulo, Brazil

Local Institution - 0092

São Paulo, Brazil

Local Institution - 0200

Victoria, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Local Institution - 0250

Québec, Quebec, Canada

Local Institution - 0192

Sherbrooke, Quebec, Canada

Local Institution - 0226

Sherbrooke, Quebec, Canada

Local Institution - 0154

Santiago, Santiago Metropolitan, Chile

Local Institution - 0155

Santiago, Santiago Metropolitan, Chile

Local Institution - 0153

Santiago, Santiago Metropolitan, Chile

Local Institution - 0246

Beijing, Beijing Municipality, China

Beijing Cancer hospital

Beijing, Beijing Municipality, China

Local Institution - 0172

Fuzhou Fujian, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Local Institution - 0241

Harbin, Heilongjiang, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Local Institution - 0175

Changsha, Hunan, China

Inner Mongolia Cancer Hospital

Hohhot, Inner Mongolia, China

Local Institution - 0233

Suzhou, Jiangsu, China

Local Institution - 0178

Nanchang, Jiangxi, China

Local Institution - 0239

Changchun, Jilin, China

Local Institution - 0177

Changchun, Jilin, China

Local Institution - 0179

Shenyang, Liaoning, China

Local Institution - 0242

Shenyang, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

Local Institution - 0181

Shanghai, Shanghai Municipality, China

Local Institution - 0249

Shanghai, Shanghai Municipality, China

Local Institution - 0234

Sichuan, Sichuan, China

Local Institution - 0182

Tianjin, Tianjin Municipality, China

Tianjin People' s Hospital

Tianjin, Tianjin Municipality, China

Local Institution - 0248

Kunming, Yunnan, China

Local Institution - 0184

Hangzhou, Zhejiang, China

Local Institution - 0174

Zhengzhou, China

Local Institution - 0151

Oulu, North Ostrobothnia, Finland

Local Institution - 0152

Turku, Southwest Finland, Finland

Local Institution - 0150

Helsinki, Finland

CHU Bordeaux Haut-Leveque

Pessac, Aquitaine, France

Local Institution - 0044

Saint-Cloud, Hauts-de-Seine, France

Chu Saint Eloi

Montpellier, Languedoc-Roussillon, France

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, Loire-Atlantique, France

Hopital Claude Huriez - CHU de Lille

Lille, Nord, France

Local Institution - 0042

Pierre-Bénite, Rhône, France

Local Institution - 0191

Paris, France

Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

Toulouse, France

Local Institution - 0163

Ulm, Baden-Wurttemberg, Germany

Klinikum Augsburg

Augsburg, Bavaria, Germany

Local Institution - 0220

Göttingen, Lower Saxony, Germany

GEFOS Gesellschaft f. onkologische Studien

Dortmund, North Rhine-Westphalia, Germany

Local Institution - 0193

Düsseldorf, North Rhine-Westphalia, Germany

Local Institution - 0231

Münster, North Rhine-Westphalia, Germany

Local Institution - 0232

Münster, North Rhine-Westphalia, Germany

Universitaetsklinikum des Saarlandes

Homburg, Saarland, Germany

HELIOS Klinikum Erfurt

Erfurt, Thuringia, Germany

Universitätsklinikum Jena

Jena, Thuringia, Germany

Klinikum Chemnitz Ggmbh

Chemnitz, Germany

Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf

Dresden, Germany

Local Institution - 0162

München, Germany

Local Institution - 0221

Würzburg, Germany

Local Institution - 0111

Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece

Evangelismos General Hospital of Athens

Athens, Attikí, Greece

General Hospital of Athens "Laiko"

Αthens, Attikí, Greece

Local Institution - 0110

Thessaloniki, Thessaloníki, Greece

Local Institution - 0197

Thessaloniki, Thessaloníki, Greece

Local Institution - 0108

Ioannina, Ípeiros, Greece

Local Institution - 0139

Bengaluru, Karnataka, India

Local Institution - 0141

Mumbai, Maharashtra, India

Local Institution - 0142

New Delhi, National Capital Territory of Delhi, India

Local Institution - 0140

Hyderabad, Telangana, India

Local Institution - 0138

Hyderabad, Telangana, India

Local Institution - 0104

Bologna, Emilia-Romagna, Italy

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Emilia-Romagna, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Local Institution - 0102

Alessandria, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Naples, Italy

Local Institution - 0157

Torino, Italy

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Aiiku Hospital

Sapporo, Hokkaido, Japan

Japanease Red Cross Society Himeji Hospital

Himeji, Hyōgo, Japan

Iwate Prefectural Central Hospital

Morioka, Iwate, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Nihon University Itabashi Hospital

Itabashiku, Tokyo, Japan

University of Yamanashi Hospital

Chūō, Yamanashi, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Japan

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, Japan

Amsterdam UMC, locatie VUmc

Amsterdam, North Holland, Netherlands

Local Institution - 0046

Groningen, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

AIDPORT Sp. z o.o.

Skórzewo, Greater Poland Voivodeship, Poland

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0190

Gdynia, Pomeranian Voivodeship, Poland

Local Institution - 0189

Lodz, Łódź Voivodeship, Poland

Local Institution - 0099

Dammam, Eastern Province, Saudi Arabia

Local Institution - 0054

Riyadh, Saudi Arabia

Local Institution - 0052

Riyadh, Saudi Arabia

Local Institution - 0059

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0060

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0061

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0058

Seoul, South Korea

Hospital Universitari Parc Tauli

Sabadell, Barcelona [Barcelona], Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Infanta Leonor

Madrid, Madrid, Comunidad de, Spain

Hospital Clinico de Valencia

Valencia, Valenciana, Comunitat, Spain

Hospital Universitario Virgen Nieves

Granada, Spain

Local Institution - 0123

Madrid, Spain

Local Institution - 0195

Istanbul- Fatih, Istanbul, Turkey (Türkiye)

Local Institution - 0194

Ankara, Turkey (Türkiye)

Local Institution - 0196

Antalya, Turkey (Türkiye)

Local Institution - 0223

Mersin, Turkey (Türkiye)

Local Institution - 0251

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Local Institution - 0252

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Norfolk and Norwich University Hospitals NHS Foundation Trust

Cringleford, England, United Kingdom

Kent and Canterbury Hospital

Canterbury, Kent, United Kingdom

Local Institution - 0213

London, London, City of, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom