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Evaluating golcadomide with rituximab for advanced follicular lymphoma

A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

PHASE2 · Celgene · NCT06425302

This study is testing if a new treatment combining golcadomide and rituximab can help people with newly diagnosed advanced follicular lymphoma feel better and improve their health.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment90 (estimated)
Ages18 Years and up
SexAll
SponsorCelgene (industry)
Drugs / interventionsradiation, rituximab
Locations68 sites (Birmingham, Alabama and 67 other locations)
Trial IDNCT06425302 on ClinicalTrials.gov

What this trial studies

This study assesses the efficacy and safety of golcadomide in combination with rituximab for patients with newly diagnosed advanced stage follicular lymphoma. Participants must have histologically confirmed Grade 1, 2, or 3a follicular lymphoma and have not received prior systemic treatment. The study aims to determine the effectiveness of this combination therapy in managing the disease and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals with newly diagnosed advanced stage follicular lymphoma who have not undergone prior systemic treatment.

Not a fit: Patients with early-stage follicular lymphoma or those who have previously received systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced follicular lymphoma.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating follicular lymphoma, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.
* Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
* Stage II to IV disease.
* Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.

  i) Bulky disease defined as:.

A. A nodal or extra nodal (except spleen) mass \> 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than \>3 cm).

ii) Presence of at least one of the following B symptoms:.

A. Fever (\>38°C) of unclear etiology.

B. Night sweats.

C. Weight loss greater than 10% within the prior 6 months.

iii) Splenomegaly with inferior margin below the umbilical line.

iv) Any one of the following cytopenia due to lymphoma:.

A. Platelets \<100,000 cells/mm3 (100 x 109/L).

B. Absolute neutrophil count (ANC) \< 1,000 cells/mm3 (1.0 x 109/L).

C. Hemoglobin \< 10g/dL (6.25 mmol/L).

v) Pleural or peritoneal serous effusion (irrespective of cell content).

vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).

Exclusion Criteria

* Clinical evidence of transformed lymphoma by investigator assessment.
* Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
* Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Birmingham, Alabama and 67 other locations

+18 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 →

Conditions: Lymphoma, Follicular, Follicular lymphoma, Grade 1-3a Follicular lymphoma, BMS-986369, CC-99282, Lymphoma, golcadomide

Last reviewed 2026-05-15 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.