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Looking for participantsPhase3

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

NCT ID: NCT06911502

View on ClinicalTrials.gov ↗

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.

Follicular Lymphoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

PRCD20eGFR

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
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.

Where Is This Study? (4 UK sites)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Cringleford NR4 7UY, United Kingdom

Recruiting
Site contact (verified)
Joel Cunningham, Site 014801603 286286

Kent and Canterbury Hospital

Canterbury CT1 3NG, United Kingdom

Recruiting
Site contact (verified)
Moya Young, Site 014701227 766877

Local Institution - 0213

London W12 0HS, United Kingdom

NOT_YET_RECRUITING

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Kim Linton, Site 014901614 463000

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

8559073286 Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-05