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 (GOLSEEK-4)

Phase 3

Not yet recruiting

• Conditions: Follicular Lymphoma
• Interventions: Drug: Golcadomide; Drug: Rituximab; Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone/Prednisolone; Drug: Bendamustine

• Registration Number: NCT06911502
• Lead Sponsor: Celgene

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Study First Posted: 2025-04-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Study Start: 2025-07-08
• Primary Completion: 2030-07-31
• Study Completion: 2030-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Participant has histologically confirmed FL (Grade 1, 2, or 3a) 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 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) ≥ 40% 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.

• Participants who are refractory to both chemotherapies as well as lenalidomide, defined as:

  1. SD/progressive disease as best response to CHOP and Bendamustine based immunochemotherapy or a response to CHOP and Bendamustine based immunochemotherapy that lasted less than 6 months AND
  2. SD/progressive disease as best response to lenalidomide based regimen or a response to lenalidomide based regimen that lasted less than 6 months.

• Other protocol-defined Inclusion/Exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Golcadomide + Rituximab	Golcadomide	-
Golcadomide + Rituximab	Rituximab	-
Rituximab + Lenalidomide/Chemotherapy	Rituximab	Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine
Rituximab + Lenalidomide/Chemotherapy	Lenalidomide	Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine
Rituximab + Lenalidomide/Chemotherapy	Cyclophosphamide	Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine
Rituximab + Lenalidomide/Chemotherapy	Doxorubicin	Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine
Rituximab + Lenalidomide/Chemotherapy	Vincristine	Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine
Rituximab + Lenalidomide/Chemotherapy	Prednisone/Prednisolone	Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine
Rituximab + Lenalidomide/Chemotherapy	Bendamustine	Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)	Up to approximately 32 Months

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR) assessed by IRAC	Up to approximately 32 Months
Overall survival (OS)	Up to approximately 83 Months
PFS as assessed by investigator	Up to approximately 32 Months
ORR as assessed by investigator	Up to approximately 32 Months
Number of participants who achieve complete metabolic response (CMR)	Up to approximately 32 Months
Duration of Response (DoR)	Up to approximately 32 Months
Event free survival (EFS)	Up to approximately 32 Months
Time to next anti-lymphoma treatment (TTNT)	Up to approximately 32 Months
PFS on next anti-lymphoma treatment (PFS2)	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	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	Up to approximately 32 Months
Minimal residual disease (MRD) negativity	Up to approximately 32 Months

Trial Locations

Locations (117)

Local Institution - 0214; 🇺🇸 Tampa, Florida, United States

Local Institution - 0189; 🇵🇱 Łódź, Łódzkie, Poland

Local Institution - 0008; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0089; 🇧🇷 Rio de Janeiro, Brazil

Local Institution - 0014; 🇺🇸 Mobile, Alabama, United States

Local Institution - 0074; 🇺🇸 Anchorage, Alaska, United States

Local Institution - 0215; 🇺🇸 Little Rock, Arkansas, United States

Local Institution - 0072; 🇺🇸 Duarte, California, United States

Local Institution - 0119; 🇺🇸 San Francisco, California, United States

Local Institution - 0066; 🇧🇷 São Paulo, Brazil

Local Institution - 0217; 🇺🇸 Tampa, Florida, United States

Local Institution - 0021; 🇺🇸 Marietta, Georgia, United States

Local Institution - 0245; 🇺🇸 Newnan, Georgia, United States

Local Institution - 0240; 🇺🇸 Arlington Heights, Illinois, United States

Local Institution - 0218; 🇺🇸 Lexington, Kentucky, United States

Local Institution - 0023; 🇺🇸 Baltimore, Maryland, United States

Local Institution - 0010; 🇺🇸 Towson, Maryland, United States

Local Institution - 0145; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0013; 🇺🇸 Hattiesburg, Mississippi, United States

Local Institution - 0144; 🇺🇸 Providence, Rhode Island, United States

Local Institution - 0212; 🇺🇸 Fort Worth, Texas, United States

Local Institution - 0030; 🇺🇸 Fredericksburg, Virginia, United States

Local Institution - 0146; 🇺🇸 Roanoke, Virginia, United States

Local Institution - 0143; 🇺🇸 Vancouver, Washington, United States

Local Institution - 0134; 🇦🇺 Westmead, New South Wales, Australia

Local Institution - 0132; 🇦🇺 Adelaide, South Australia, Australia

Local Institution - 0131; 🇦🇺 Hobart, Tasmania, Australia

Local Institution - 0128; 🇦🇺 Heidelberg, Victoria, Australia

Local Institution - 0198; 🇦🇺 Malvern, Victoria, Australia

Local Institution - 0127; 🇦🇺 Perth, Western Australia, Australia

Local Institution - 0224; 🇦🇺 Perth, Western Australia, Australia

Local Institution - 0159; 🇧🇷 Vitoria, Espírito Santo, Brazil

Local Institution - 0088; 🇧🇷 Niterói, Rio De Janeiro, Brazil

Local Institution - 0087; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Local Institution - 0079; 🇧🇷 Sao Paulo, São Paulo, Brazil

Local Institution - 0092; 🇧🇷 São Paulo, Brazil

Local Institution - 0200; 🇨🇦 Victoria, British Columbia, Canada

Local Institution - 0035; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0192; 🇨🇦 Sherbrooke, Quebec, Canada

Local Institution - 0226; 🇨🇦 Sherbrooke, Quebec, Canada

Local Institution - 0154; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0155; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0153; 🇨🇱 Santiago, Región Metropolitana De Santiago, Chile

Local Institution - 0171; 🇨🇳 Beijing, Beijing, China

Local Institution - 0173; 🇨🇳 Guangzhou, Guangdong, China

Local Institution - 0176; 🇨🇳 Wuhan, Hubei, China

Local Institution - 0151; 🇫🇮 Oulu, Pohjois-Pohjanmaa, Finland

Local Institution - 0152; 🇫🇮 Turku, Varsinais-Suomi, Finland

Local Institution - 0150; 🇫🇮 Helsinki, Finland

Local Institution - 0100; 🇫🇷 Pessac, Aquitaine, France

Local Institution - 0121; 🇫🇷 Toulouse, Haute-Garonne, France

Local Institution - 0044; 🇫🇷 Saint-Cloud, Hauts-de-Seine, France

Local Institution - 0047; 🇫🇷 Montpellier, Hérault, France

Local Institution - 0120; 🇫🇷 Nantes, Loire-Atlantique, France

Local Institution - 0048; 🇫🇷 Lille, Nord, France

Local Institution - 0042; 🇫🇷 Pierre-Bénite, Rhône, France

Local Institution - 0191; 🇫🇷 Paris, France

Local Institution - 0163; 🇩🇪 Ulm, Baden-Württemberg, Germany

Local Institution - 0161; 🇩🇪 Augsburg, Bayern, Germany

Local Institution - 0220; 🇩🇪 Göttingen, Niedersachsen, Germany

Local Institution - 0102; 🇮🇹 Alessandria, Italy

Local Institution - 0166; 🇩🇪 Dortmund, Nordrhein-Westfalen, Germany

Local Institution - 0193; 🇩🇪 Düsseldorf, Nordrhein-Westfalen, Germany

Local Institution - 0231; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Local Institution - 0232; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Local Institution - 0164; 🇩🇪 Homburg, Saarland, Germany

Local Institution - 0165; 🇩🇪 Chemnitz, Sachsen, Germany

Local Institution - 0222; 🇩🇪 Erfurt, Thüringen, Germany

Local Institution - 0167; 🇩🇪 Jena, Thüringen, Germany

Local Institution - 0187; 🇩🇪 Dresden, Germany

Local Institution - 0162; 🇩🇪 München, Germany

Local Institution - 0221; 🇩🇪 Wuerzburg, Germany

Local Institution - 0109; 🇬🇷 Athens, Attikí, Greece

Local Institution - 0107; 🇬🇷 Αthens, Attikí, Greece

Local Institution - 0110; 🇬🇷 Thessaloniki, Thessaloníki, Greece

Local Institution - 0197; 🇬🇷 Thessaloniki, Thessaloníki, Greece

Local Institution - 0111; 🇬🇷 Alexandroupolis, Greece

Local Institution - 0108; 🇬🇷 Ioannina, Ípeiros, Greece

Local Institution - 0142; 🇮🇳 New Delhi, Delhi, India

Local Institution - 0139; 🇮🇳 Bengaluru, Karnataka, India

Local Institution - 0141; 🇮🇳 Mumbai, Maharashtra, India

Local Institution - 0140; 🇮🇳 Hyderabad, Telangana, India

Local Institution - 0138; 🇮🇳 Hyderabad, Telangana, India

Local Institution - 0104; 🇮🇹 Bologna, Emilia-Romagna, Italy

Local Institution - 0101; 🇮🇹 Meldola, Emilia-Romagna, Italy

Local Institution - 0103; 🇮🇹 Rozzano, Milano, Italy

Local Institution - 0106; 🇮🇹 Pisa, Toscana, Italy

Local Institution - 0105; 🇮🇹 Napoli, Italy

Local Institution - 0157; 🇮🇹 Torino, Italy

Local Institution - 0059; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0060; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0061; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0058; 🇰🇷 Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of

Local Institution - 0050; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Local Institution - 0046; 🇳🇱 Groningen, Netherlands

Local Institution - 0053; 🇳🇱 Utrecht, Netherlands

Local Institution - 0188; 🇵🇱 Warszawa, Mazowieckie, Poland

Local Institution - 0186; 🇵🇱 Kraków, Małopolskie, Poland

Local Institution - 0190; 🇵🇱 Gdynia, Pomorskie, Poland

Local Institution - 0185; 🇵🇱 Skórzewo, Wielkopolskie, Poland

Local Institution - 0099; 🇸🇦 Dammam, Ash Sharqīyah, Saudi Arabia

Local Institution - 0054; 🇸🇦 Riyadh, Saudi Arabia

Local Institution - 0052; 🇸🇦 Riyadh, Saudi Arabia

Local Institution - 0158; 🇪🇸 Sabadell, Barcelona [Barcelona], Spain

Local Institution - 0122; 🇪🇸 Santander, Cantabria, Spain

Local Institution - 0124; 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Local Institution - 0125; 🇪🇸 Valencia, Valenciana, Comunitat, Spain

Local Institution - 0126; 🇪🇸 Granada, Spain

Local Institution - 0123; 🇪🇸 Madrid, Spain

Local Institution - 0195; 🇹🇷 Istanbul- Fatih, İstanbul, Turkey

Local Institution - 0194; 🇹🇷 Ankara, Turkey

Local Institution - 0196; 🇹🇷 Antalya, Turkey

Local Institution - 0223; 🇹🇷 Mersin, Turkey

Local Institution - 0148; 🇬🇧 Cringleford, England, United Kingdom

Local Institution - 0147; 🇬🇧 Canterbury, Kent, United Kingdom

Local Institution - 0213; 🇬🇧 London, London, City Of, United Kingdom

Local Institution - 0149; 🇬🇧 Manchester, United Kingdom