New hope for lymphoma: golcadomide combo enters phase 3 trial

NCT ID NCT06911502

Disease control Sponsor: Celgene Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial compares a new drug combination (golcadomide plus rituximab) against standard treatments for people with follicular lymphoma that has come back or stopped responding to at least one prior therapy. About 400 participants will be randomly assigned to receive either the new combo or one of several standard options. The main goal is to see if the new combo delays cancer progression better than current choices.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: golcadomide (a targeted drug) combined with rituximab (an antibody)
What this could lead to: If successful, this combination could offer a new, more effective treatment option for people with follicular lymphoma that has returned or not responded to prior therapy.
What could go wrong: This is a Phase 3 trial, but the new drug combination may not prove better than existing treatments. Side effects from the drugs are possible, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

follicular lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Follicular lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

157 sites in 21 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AIDPORT Sp. z o.o.
RECRUITING

Skórzewo, Greater Poland Voivodeship, 60-185, Poland
Aiiku Hospital
RECRUITING

Sapporo, Hokkaido, 064-0804, Japan
Alaska Oncology and Hematology
RECRUITING

Anchorage, Alaska, 99508, United States
Amsterdam UMC, locatie VUmc
RECRUITING

Amsterdam, North Holland, 1081 HV, Netherlands
Azienda Ospedaliero Universitaria Pisana
RECRUITING

Pisa, Tuscany, 56126, Italy
Beijing Cancer hospital
RECRUITING

Beijing, Beijing Municipality, 100142, China
Blue Ridge Cancer Care
RECRUITING

Roanoke, Virginia, 24014, United States
CHU Bordeaux Haut-Leveque
RECRUITING

Pessac, Aquitaine, 33600, France
Cabrini Hospital - Malvern
RECRUITING

Malvern, Victoria, 3144, Australia
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
RECRUITING

Nantes, Loire-Atlantique, 44093 Cedex 1, France
Chu Saint Eloi
RECRUITING

Montpellier, Languedoc-Roussillon, 34295, France
City of Hope Comprehensive Cancer Center
RECRUITING

Duarte, California, 91010, United States
Evangelismos General Hospital of Athens
RECRUITING

Athens, Attikí, 106 76, Greece
GEFOS Gesellschaft f. onkologische Studien
RECRUITING

Dortmund, North Rhine-Westphalia, 44263, Germany
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
RECRUITING

Dresden, 01307, Germany
General Hospital of Athens "Laiko"
RECRUITING

Αthens, Attikí, 11526, Greece
Greater Baltimore Medical Center
RECRUITING

Towson, Maryland, 21204, United States
HELIOS Klinikum Erfurt
RECRUITING

Erfurt, Thuringia, 99089, Germany
Hattiesburg Clinic Hematology/Oncology
RECRUITING

Hattiesburg, Mississippi, 39401-7233, United States
Hematology Oncology Associates of Fredericksburg
RECRUITING

Fredericksburg, Virginia, 22408, United States
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
RECRUITING

Hiroshima, 730-0052, Japan
Hopital Claude Huriez - CHU de Lille
RECRUITING

Lille, Nord, 59037, France
Hospital Clinico de Valencia
RECRUITING

Valencia, Valenciana, Comunitat, 46010, Spain
Hospital Universitari Parc Tauli
RECRUITING

Sabadell, Barcelona [Barcelona], 08208, Spain
Hospital Universitario Infanta Leonor
RECRUITING

Madrid, Madrid, Comunidad de, 28031, Spain
Hospital Universitario Marqués de Valdecilla
RECRUITING

Santander, Cantabria, 39008, Spain
Hospital Universitario Virgen Nieves
RECRUITING

Granada, 18012, Spain
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
RECRUITING

Meldola, Emilia-Romagna, 47014, Italy
Infirmary Cancer Care
RECRUITING

Mobile, Alabama, 36607, United States
Inner Mongolia Cancer Hospital
RECRUITING

Hohhot, Inner Mongolia, 010020, China
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
RECRUITING

Toulouse, 31100, France
Istituto Clinico Humanitas
RECRUITING

Rozzano, Milano, 20089, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
RECRUITING

Naples, 80131, Italy
Iwate Prefectural Central Hospital
RECRUITING

Morioka, Iwate, 020-0066, Japan
Japanease Red Cross Society Himeji Hospital
RECRUITING

Himeji, Hyōgo, 670-8540, Japan
Kent and Canterbury Hospital
RECRUITING

Canterbury, Kent, CT1 3NG, United Kingdom
Klinikum Augsburg
RECRUITING

Augsburg, Bavaria, 86156, Germany
Klinikum Chemnitz Ggmbh
RECRUITING

Chemnitz, 09116, Germany
Kyushu University Hospital
RECRUITING

Fukuoka, 812-8582, Japan
Local Institution - 0008
NOT_YET_RECRUITING

Jacksonville, Florida, 32256, United States
Local Institution - 0023
NOT_YET_RECRUITING

Baltimore, Maryland, 21201, United States
Local Institution - 0042
NOT_YET_RECRUITING

Pierre-Bénite, Rhône, 69310, France
Local Institution - 0044
NOT_YET_RECRUITING

Saint-Cloud, Hauts-de-Seine, 92210, France
Local Institution - 0046
NOT_YET_RECRUITING

Groningen, 9713 GZ, Netherlands
Local Institution - 0052
NOT_YET_RECRUITING

Riyadh, 12713, Saudi Arabia
Local Institution - 0054
NOT_YET_RECRUITING

Riyadh, 11426, Saudi Arabia
Local Institution - 0058
NOT_YET_RECRUITING

Seoul, 07345, South Korea
Local Institution - 0059
NOT_YET_RECRUITING

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Local Institution - 0060
NOT_YET_RECRUITING

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Local Institution - 0061
NOT_YET_RECRUITING

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Local Institution - 0066
NOT_YET_RECRUITING

São Paulo, 01246-000, Brazil
Local Institution - 0079
NOT_YET_RECRUITING

São Paulo, São Paulo, 04543-000, Brazil
Local Institution - 0087
NOT_YET_RECRUITING

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Local Institution - 0088
NOT_YET_RECRUITING

Niterói, Rio de Janeiro, 24220-070, Brazil
Local Institution - 0089
NOT_YET_RECRUITING

Rio de Janeiro, 22250-905, Brazil
Local Institution - 0092
NOT_YET_RECRUITING

São Paulo, 05652-900, Brazil
Local Institution - 0099
NOT_YET_RECRUITING

Dammam, Eastern Province, 31444, Saudi Arabia
Local Institution - 0102
NOT_YET_RECRUITING

Alessandria, 15121, Italy
Local Institution - 0104
NOT_YET_RECRUITING

Bologna, Emilia-Romagna, 40138, Italy
Local Institution - 0108
NOT_YET_RECRUITING

Ioannina, Ípeiros, 455 00, Greece
Local Institution - 0110
NOT_YET_RECRUITING

Thessaloniki, Thessaloníki, 570 10, Greece
Local Institution - 0111
NOT_YET_RECRUITING

Alexandroupoli, Anatolikí Makedonía Kai Thráki, 681 00, Greece
Local Institution - 0123
NOT_YET_RECRUITING

Madrid, 28040, Spain
Local Institution - 0127
NOT_YET_RECRUITING

Perth, Western Australia, 6000, Australia
Local Institution - 0128
NOT_YET_RECRUITING

Heidelberg, Victoria, 3084, Australia
Local Institution - 0131
NOT_YET_RECRUITING

Hobart, Tasmania, 7000, Australia
Local Institution - 0132
NOT_YET_RECRUITING

Adelaide, South Australia, 5042, Australia
Local Institution - 0138
NOT_YET_RECRUITING

Hyderabad, Telangana, 500082, India
Local Institution - 0139
NOT_YET_RECRUITING

Bengaluru, Karnataka, 560099, India
Local Institution - 0140
NOT_YET_RECRUITING

Hyderabad, Telangana, 500033, India
Local Institution - 0141
NOT_YET_RECRUITING

Mumbai, Maharashtra, 400 057, India
Local Institution - 0142
NOT_YET_RECRUITING

New Delhi, National Capital Territory of Delhi, 110029, India
Local Institution - 0143
NOT_YET_RECRUITING

Vancouver, Washington, 98684, United States
Local Institution - 0144
NOT_YET_RECRUITING

Providence, Rhode Island, 02903, United States
Local Institution - 0145
NOT_YET_RECRUITING

Boston, Massachusetts, 02114, United States
Local Institution - 0150
NOT_YET_RECRUITING

Helsinki, 00029, Finland
Local Institution - 0151
NOT_YET_RECRUITING

Oulu, North Ostrobothnia, 90220, Finland
Local Institution - 0152
NOT_YET_RECRUITING

Turku, Southwest Finland, 20521, Finland
Local Institution - 0153
NOT_YET_RECRUITING

Santiago, Santiago Metropolitan, 8420383, Chile
Local Institution - 0154
NOT_YET_RECRUITING

Santiago, Santiago Metropolitan, 7580206, Chile
Local Institution - 0155
NOT_YET_RECRUITING

Santiago, Santiago Metropolitan, 8320325, Chile
Local Institution - 0157
NOT_YET_RECRUITING

Torino, 10126, Italy
Local Institution - 0159
NOT_YET_RECRUITING

Vitória, Espírito Santo, 29041-295, Brazil
Local Institution - 0162
NOT_YET_RECRUITING

München, 81337, Germany
Local Institution - 0163
NOT_YET_RECRUITING

Ulm, Baden-Wurttemberg, 89081, Germany
Local Institution - 0172
NOT_YET_RECRUITING

Fuzhou Fujian, Fujian, 350001, China
Local Institution - 0174
NOT_YET_RECRUITING

Zhengzhou, 450008, China
Local Institution - 0175
NOT_YET_RECRUITING

Changsha, Hunan, 410008, China
Local Institution - 0177
NOT_YET_RECRUITING

Changchun, Jilin, 130021, China
Local Institution - 0178
NOT_YET_RECRUITING

Nanchang, Jiangxi, 330006, China
Local Institution - 0179
NOT_YET_RECRUITING

Shenyang, Liaoning, 110004, China
Local Institution - 0181
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200032, China
Local Institution - 0182
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300060, China
Local Institution - 0184
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310022, China
Local Institution - 0189
NOT_YET_RECRUITING

Lodz, Łódź Voivodeship, 93-513, Poland
Local Institution - 0190
NOT_YET_RECRUITING

Gdynia, Pomeranian Voivodeship, 81-519, Poland
Local Institution - 0191
NOT_YET_RECRUITING

Paris, 75010, France
Local Institution - 0192
NOT_YET_RECRUITING

Sherbrooke, Quebec, J1H 5N4, Canada
Local Institution - 0193
NOT_YET_RECRUITING

Düsseldorf, North Rhine-Westphalia, 40225, Germany
Local Institution - 0194
NOT_YET_RECRUITING

Ankara, 06100, Turkey (Türkiye)
Local Institution - 0195
NOT_YET_RECRUITING

Istanbul- Fatih, Istanbul, 34098, Turkey (Türkiye)
Local Institution - 0196
NOT_YET_RECRUITING

Antalya, 07059, Turkey (Türkiye)
Local Institution - 0197
NOT_YET_RECRUITING

Thessaloniki, Thessaloníki, 570 10, Greece
Local Institution - 0200
NOT_YET_RECRUITING

Victoria, British Columbia, V8R 6V5, Canada
Local Institution - 0212
NOT_YET_RECRUITING

Fort Worth, Texas, 76104, United States
Local Institution - 0213
NOT_YET_RECRUITING

London, London, City of, W12 0HS, United Kingdom
Local Institution - 0214
NOT_YET_RECRUITING

Tampa, Florida, 33606, United States
Local Institution - 0215
NOT_YET_RECRUITING

Little Rock, Arkansas, 72205, United States
Local Institution - 0216
NOT_YET_RECRUITING

Westwood, Kansas, 66205, United States
Local Institution - 0217
NOT_YET_RECRUITING

Tampa, Florida, 33612, United States
Local Institution - 0218
NOT_YET_RECRUITING

Lexington, Kentucky, 40536, United States
Local Institution - 0220
NOT_YET_RECRUITING

Göttingen, Lower Saxony, 37075, Germany
Local Institution - 0221
NOT_YET_RECRUITING

Würzburg, 97080, Germany
Local Institution - 0223
NOT_YET_RECRUITING

Mersin, 33343, Turkey (Türkiye)
Local Institution - 0224
WITHDRAWN

Perth, Western Australia, 6000, Australia
Local Institution - 0225
NOT_YET_RECRUITING

Birmingham, Alabama, 35205, United States
Local Institution - 0226
WITHDRAWN

Sherbrooke, Quebec, J1H 5N4, Canada
Local Institution - 0230
NOT_YET_RECRUITING

San Antonio, Texas, 78240, United States
Local Institution - 0231
WITHDRAWN

Münster, North Rhine-Westphalia, 48153, Germany
Local Institution - 0232
NOT_YET_RECRUITING

Münster, North Rhine-Westphalia, 48153, Germany
Local Institution - 0233
NOT_YET_RECRUITING

Suzhou, Jiangsu, 215006, China
Local Institution - 0234
NOT_YET_RECRUITING

Sichuan, Sichuan, 646000, China
Local Institution - 0238
NOT_YET_RECRUITING

Fairfax, Virginia, 22304, United States
Local Institution - 0239
NOT_YET_RECRUITING

Changchun, Jilin, 130000, China
Local Institution - 0240
NOT_YET_RECRUITING

Arlington Heights, Illinois, 60005, United States
Local Institution - 0241
NOT_YET_RECRUITING

Harbin, Heilongjiang, 150081, China
Local Institution - 0242
NOT_YET_RECRUITING

Shenyang, Liaoning, 110042, China
Local Institution - 0243
NOT_YET_RECRUITING

Waukee, Iowa, 50309, United States
Local Institution - 0244
NOT_YET_RECRUITING

Boston, Massachusetts, 02215, United States
Local Institution - 0246
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100038, China
Local Institution - 0247
NOT_YET_RECRUITING

Boston, Massachusetts, 02215, United States
Local Institution - 0248
NOT_YET_RECRUITING

Kunming, Yunnan, 650118, China
Local Institution - 0249
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200065, China
Local Institution - 0250
NOT_YET_RECRUITING

Québec, Quebec, G1J 1Z4, Canada
Local Institution - 0251
NOT_YET_RECRUITING

Abu Dhabi, Abu Dhabi Emirate, 11001, United Arab Emirates
Local Institution - 0252
NOT_YET_RECRUITING

Abu Dhabi, Abu Dhabi Emirate, 92510, United Arab Emirates
Local Institution - 0253
NOT_YET_RECRUITING

Iowa City, Iowa, 52242, United States
Nagoya University Hospital
RECRUITING

Nagoya, Aichi-ken, 466-8560, Japan
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
RECRUITING

Warsaw, Masovian Voivodeship, 02-781, Poland
National Cancer Center Hospital
RECRUITING

Chuo-ku, Tokyo, 104-0045, Japan
National Hospital Organization Kyushu Medical Center
RECRUITING

Fukuoka, 810-8563, Japan
Nihon University Itabashi Hospital
RECRUITING

Itabashiku, Tokyo, 173-8610, Japan
Norfolk and Norwich University Hospitals NHS Foundation Trust
RECRUITING

Cringleford, England, NR4 7UY, United Kingdom
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
RECRUITING

Marietta, Georgia, 30060, United States
Pratia MCM Krakow
RECRUITING

Krakow, Lesser Poland Voivodeship, 30-727, Poland
Princess Margaret Cancer Centre
RECRUITING

Toronto, Ontario, M5G 2M9, Canada
Shandong Cancer Hospital
RECRUITING

Jinan, Shandong, 250117, China
Southeastern Regional Medical Center
RECRUITING

Newnan, Georgia, 30265, United States
Sun Yat-sen University Cancer Center
RECRUITING

Guangzhou, Guangdong, 510060, China
Texas Oncology - Central/South Texas
RECRUITING

Austin, Texas, 78705, United States
Texas Oncology - Northeast Texas
RECRUITING

Tyler, Texas, 75702, United States
The Christie NHS Foundation Trust
RECRUITING

Manchester, M20 4BX, United Kingdom
Tianjin People' s Hospital
RECRUITING

Tianjin, Tianjin Municipality, 300121, China
UCSF Helen Diller Medical Center at Parnassus Heights
RECRUITING

San Francisco, California, 94143, United States
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING

Wuhan, Hubei, 430022, China
Universitaetsklinikum des Saarlandes
RECRUITING

Homburg, Saarland, 66424, Germany
Universitair Medisch Centrum Utrecht
RECRUITING

Utrecht, 3584 CX, Netherlands
University of Yamanashi Hospital
RECRUITING

Chūō, Yamanashi, 409-3898, Japan
Universitätsklinikum Jena
RECRUITING

Jena, Thuringia, 07747, Germany
Westmead Hospital
RECRUITING

Westmead, New South Wales, 2145, Australia

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