A Study of Golcadomide and Rituximab for Relapsed/Refractory Follicular Lymphoma
This study is looking at a new combination treatment for follicular lymphoma that has come back or not responded to previous treatments. It compares a drug called golcadomide given with rituximab to other standard treatments chosen by your doctor (investigator's choice). The study wants to see if golcadomide and rituximab are more effective and safe. To join, you must have follicular lymphoma that has returned or not responded after at least one prior treatment. The main goal is to see how long people live without their cancer getting worse (progression-free survival). The study plans to enroll 400 people, but its current status is unclear.
- Study design
- This is a Phase 3, multicenter, randomized, open-label study comparing two treatment approaches. It plans to enroll 400 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be assessed for up to approximately 32 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06911502
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)
Recruiting
PHASE3Ages 18+InterventionalTreatmentCelgene
~400 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:GolcadomideRituximabLenalidomideCyclophosphamideDoxorubicinVincristine
At a glance
Recruiting sites
62 of 160 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)
Measured over Up to approximately 32 Months
Conditions
Where it's being run
160 sites across 108 statesTexas4
North Rhine-Westphalia4
Germany4
Florida3
Massachusetts3
Virginia3
Brazil3
Quebec3
Study leadership
- Bristol Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
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
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.
What this trial measures
- Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)Up to approximately 32 Months