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Clinical Trials in the UK / NCT06911502
Recruiting Phase 3

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)

NCT06911502 · tracked via the Priya Life Science UK tracker
Sponsor
Celgene
Phase
Phase 3
Started
2025-07-28
Last updated
2026-05-20

Condition(s) studied

Follicular Lymphoma

Investigational drug(s) / intervention(s)

GolcadomideRituximabLenalidomideCyclophosphamideDoxorubicinVincristinePrednisone/PrednisoloneBendamustine

Golcadomide: Specified dose on specified days

Rituximab: Specified dose on specified days

Lenalidomide: Specified dose on specified days

Cyclophosphamide: Specified dose on specified days

Doxorubicin: Specified dose on specified days

Vincristine: Specified dose on specified days

Prednisone/Prednisolone: Specified dose on specified days

Bendamustine: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (160)

FacilityCityRegionStatus
Local Institution - 0225 Birmingham Alabama Not Yet Recruiting
Infirmary Cancer Care Mobile Alabama Recruiting
Alaska Oncology and Hematology Anchorage Alaska Recruiting
Local Institution - 0215 Little Rock Arkansas Not Yet Recruiting
City of Hope Comprehensive Cancer Center Duarte California Recruiting
UCSF Helen Diller Medical Center at Parnassus Heights San Francisco California Recruiting
Local Institution - 0008 Jacksonville Florida Not Yet Recruiting
Local Institution - 0214 Tampa Florida Not Yet Recruiting
Local Institution - 0217 Tampa Florida Not Yet Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital Marietta Georgia Recruiting
Southeastern Regional Medical Center Newnan Georgia Recruiting
Local Institution - 0240 Arlington Heights Illinois Not Yet Recruiting
Local Institution - 0253 Iowa City Iowa Not Yet Recruiting
Local Institution - 0243 Waukee Iowa Not Yet Recruiting
Local Institution - 0216 Westwood Kansas Not Yet Recruiting
Local Institution - 0218 Lexington Kentucky Not Yet Recruiting
Local Institution - 0023 Baltimore Maryland Not Yet Recruiting
Greater Baltimore Medical Center Towson Maryland Recruiting
Local Institution - 0145 Boston Massachusetts Not Yet Recruiting
Local Institution - 0244 Boston Massachusetts Not Yet Recruiting
Local Institution - 0247 Boston Massachusetts Not Yet Recruiting
Hattiesburg Clinic Hematology/Oncology Hattiesburg Mississippi Recruiting
Local Institution - 0144 Providence Rhode Island Not Yet Recruiting
Texas Oncology - Central/South Texas Austin Texas Recruiting
Local Institution - 0212 Fort Worth Texas Not Yet Recruiting
Local Institution - 0230 San Antonio Texas Not Yet Recruiting
Texas Oncology - Northeast Texas Tyler Texas Recruiting
Local Institution - 0238 Fairfax Virginia Not Yet Recruiting
Hematology Oncology Associates of Fredericksburg Fredericksburg Virginia Recruiting
Blue Ridge Cancer Care Roanoke Virginia Recruiting
Local Institution - 0143 Vancouver Washington Not Yet Recruiting
Westmead Hospital Westmead New South Wales Recruiting
Local Institution - 0132 Adelaide South Australia Not Yet Recruiting
Local Institution - 0131 Hobart Tasmania Not Yet Recruiting
Local Institution - 0128 Heidelberg Victoria Not Yet Recruiting
Cabrini Hospital - Malvern Malvern Victoria Recruiting
Local Institution - 0127 Perth Western Australia Not Yet Recruiting
Local Institution - 0224 Perth Western Australia Withdrawn
Local Institution - 0159 Vitória Espírito Santo Not Yet Recruiting
Local Institution - 0088 Niterói Rio de Janeiro Not Yet Recruiting

+ 120 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile → 📄 Revlimid (lenalidomide) drug profile →

More Celgene trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06911502 on ClinicalTrials.gov ↗ ← All trials in the UK