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Golcadomide plus rituximab versus investigator's choice for relapsed or refractory follicular lymphoma

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

Phase 3 Interventional Celgene · NCT06911502

This trial tests whether combining golcadomide with rituximab works better than standard investigator‑selected treatments for adults with relapsed or refractory follicular lymphoma who have had at least one prior systemic therapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorCelgene Industry-sponsored
Drugs / interventionsrituximab, obinutuzumab, chemotherapy, radiation, cyclophosphamide
Locations160 sites (Birmingham, Alabama and 159 other locations)
Trial IDNCT06911502 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, open‑label Phase 3 trial comparing golcadomide plus rituximab against investigator's choice therapy in participants with relapsed or refractory follicular lymphoma who have received at least one prior systemic treatment. Eligible participants must have histologically confirmed grade 1, 2, or 3a follicular lymphoma, PET‑positive measurable disease, and meet specified performance status criteria. Participants are randomized to receive the experimental combination or a standard regimen chosen by their investigator, with follow‑up for response, disease control, and safety outcomes. The study will compare efficacy and adverse event profiles between the arms to determine whether the golcadomide combination provides improved clinical benefit.

Who should consider this trial

Good fit: Adults with histologically confirmed grade 1–3a follicular lymphoma that is PET‑positive and measurable, who are relapsed or refractory after at least one prior systemic therapy and meet ECOG performance criteria, are the intended participants.

Not a fit: Patients who are newly diagnosed, have non‑measurable or PET‑negative disease, have histologic subtypes excluded from the protocol (for example grade 3b), or have comorbidities that prevent protocol therapy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the golcadomide plus rituximab combination could prolong remissions and provide a new treatment option for people with relapsed or refractory follicular lymphoma.

How similar studies have performed: Related approaches combining an immunomodulatory agent with rituximab, such as lenalidomide plus rituximab, have shown activity in relapsed follicular lymphoma, though golcadomide is a newer agent being tested for additional benefit.

Eligibility criteria

Show full inclusion / exclusion 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:

  1. Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.
  2. 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:

  1. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L),
  2. PLT count ≥ 75,000 cells/mm3 (75 x 109 /L)
  3. 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) 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 this trial is running

Birmingham, Alabama and 159 other locations

+110 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Follicular LymphomaSecond Line Follicular LymphomaThird Line Follicular LymphomaRelapsed/refractory follicular lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.