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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)

RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Open Label 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

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Celgene · Participants: 400 · Started: Jul 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06911502

Locations in the U.S.

AlabamaLocal Institution - 0225, Birmingham (Not yet recruiting)
Infirmary Cancer Care, Mobile
AlaskaAlaska Oncology and Hematology, Anchorage
ArkansasLocal Institution - 0215, Little Rock (Not yet recruiting)
CaliforniaCity of Hope Comprehensive Cancer Center, Duarte
UCSF Helen Diller Medical Center at Parnassus Heights, San Francisco
FloridaLocal Institution - 0008, Jacksonville (Not yet recruiting)
Local Institution - 0214, Tampa (Not yet recruiting)
Local Institution - 0217, Tampa (Not yet recruiting)
GeorgiaNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Marietta
Southeastern Regional Medical Center, Newnan
IllinoisLocal Institution - 0240, Arlington Heights (Not yet recruiting)
IowaLocal Institution - 0253, Iowa City (Not yet recruiting)
Local Institution - 0243, Waukee (Not yet recruiting)
KansasLocal Institution - 0216, Westwood (Not yet recruiting)
KentuckyLocal Institution - 0218, Lexington (Not yet recruiting)
MarylandLocal Institution - 0023, Baltimore (Not yet recruiting)
Greater Baltimore Medical Center, Towson
MassachusettsLocal Institution - 0145, Boston (Not yet recruiting)
Local Institution - 0244, Boston (Not yet recruiting)
Local Institution - 0247, Boston (Not yet recruiting)
MississippiHattiesburg Clinic Hematology/Oncology, Hattiesburg
Rhode IslandLocal Institution - 0144, Providence (Not yet recruiting)
TexasTexas Oncology - Central/South Texas, Austin
Local Institution - 0212, Fort Worth (Not yet recruiting)
Local Institution - 0230, San Antonio (Not yet recruiting)
Texas Oncology - Northeast Texas, Tyler
VirginiaLocal Institution - 0238, Fairfax (Not yet recruiting)
Hematology Oncology Associates of Fredericksburg, Fredericksburg
Blue Ridge Cancer Care, Roanoke
WashingtonLocal Institution - 0143, Vancouver (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.