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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Infirmary Cancer Care
  Mobile, Alabama, United States Recruiting
• Alaska Oncology and Hematology
  Anchorage, Alaska, United States Recruiting
• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Recruiting
• UCSF Helen Diller Medical Center at Parnassus Heights
  San Francisco, California, United States Recruiting
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  Marietta, Georgia, United States Recruiting
• Southeastern Regional Medical Center
  Newnan, Georgia, United States Recruiting

+110 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 8559073286

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.