At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Golcadomide (drug), Rituximab (drug), Lenalidomide (drug), Cyclophosphamide (drug)
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- Golcadomide — drug: Specified dose on specified days · Rituximab — drug: Specified dose on specified days · Lenalidomide — drug: Specified dose on specified days · Cyclophosphamide — drug: Specified dose on specified days · Doxorubicin — drug: Specified dose on specified days · Vincristine — drug: Specified dose on specified days · Prednisone/Prednisolone — drug: Specified dose on specified days · Bendamustine — drug: Specified dose on specified days
- Patient visit burden
- Not specified by the sponsor
In plain English
This study (GOLSEEK-4) looks at follicular lymphoma, a type of blood cancer, that has come back (relapsed) or has not responded to treatment (refractory) after at least one previous course of systemic (whole-body) therapy. It compares a new drug combination called golcadomide plus rituximab against a treatment chosen by the doctor running the study (the investigator's choice). The sponsor is Celgene.
Who can take part
- Confirmed follicular lymphoma (Grade 1, 2, 3a or classic type) based on a tissue sample; a biopsy from the latest relapse is required if available
- Disease that has come back after a previous response, or did not respond well or lasted under 6 months after the most recent treatment
- Able to carry out day-to-day activities (performance status 0–2; 3 allowed only if caused by the lymphoma itself)
- Disease that shows up on a PET (positron emission tomography) scan and can be measured on a CT scan
- A doctor has decided anti-lymphoma treatment is needed, based on set criteria (GELF)
- At least one previous course of whole-body treatment that included an anti-CD20 antibody medicine (such as rituximab or obinutuzumab) plus an alkylating chemotherapy medicine (such as cyclophosphamide or bendamustine); radiotherapy alone does not count
- Healthy enough blood counts, kidney function and liver blood tests within set limits
- For those due to have anthracycline chemotherapy, adequate heart function shown on a heart scan
Who may not be able to
- Signs or history of a mixed lymphoma including diffuse large B-cell lymphoma, or lymphoma that has changed (transformed) into a faster-growing type
- Grade 3b follicular lymphoma or a rare type called duodenal-type follicular lymphoma
- Any other type of lymphoma
- Lymphoma in or around the brain or spinal cord (central nervous system)
- Stroke or bleeding in the brain within 6 months before joining
- Blood clot in a vein (DVT) or lung (pulmonary embolism) within 1 month before joining
- A history of progressive multifocal leukoencephalopathy (a rare brain infection)
- Ongoing diarrhoea or problems absorbing food (grade 2 or worse) despite treatment
- Another cancer that has not been in remission for at least 3 years (some non-invasive cancers allowed)
- Any other medical condition, abnormal test result or mental illness that, in the judgement of the study doctor or sponsor, would stop the person taking part properly or affect the study results
What taking part involves
- • Being given golcadomide together with rituximab, or a treatment chosen by the study doctor — not stated exactly which treatments count as the investigator's choice, so ask the trial team
- • Treatment details such as how the drugs are given, how often, and for how long are not stated — ask the trial team
Time commitment: Visits, duration and what taking part day-to-day involves are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 400
- Started
- 2025-07-28
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for follicular lymphoma
- • Phase3 - 400 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with follicular lymphoma
Where?
- • Cringleford - Norfolk and Norwich University Hospitals NHS Foundation Trust
- • Canterbury - Kent and Canterbury Hospital
- • London - Local Institution - 0213
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 3 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ radiation therapy does not count as a line of therapy f
What the study is looking for
- ✓\- Relapsed or refractory disease: i) Relapsed FL is defined as relapse after an initial response of CR or PR to the...
- ✓ii) Refractory FL is defined as best response of SD or PD or a response that lasted less than 6 months to the most...
- ✓activity scale (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not other health conditions).
- ✓Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe...
- ✓Lab parameters:
Who cannot take part
- ✗Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th...
- ✗Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or...
- ✗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/lung embolism within 1 month prior to enrollment.
See the full criteria
Where Is This Study? (4 UK sites)
Norfolk and Norwich University Hospitals NHS Foundation Trust
Cringleford NR4 7UY, United Kingdom
Kent and Canterbury Hospital
Canterbury CT1 3NG, United Kingdom
Local Institution - 0213
London W12 0HS, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Sponsor contactCONTACT
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