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Comparing golcadomide with R-CHOP to placebo with R-CHOP for high-risk large B-cell lymphoma

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)

PHASE3 · Celgene · NCT06356129

This study is testing if adding golcadomide to standard R-CHOP chemotherapy can help people with high-risk large B-cell lymphoma feel better compared to just R-CHOP with a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment850 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorCelgene (industry)
Drugs / interventionsrituximab, chemotherapy, cyclophosphamide, doxorubicin, prednisone
Locations343 sites (Mobile, Alabama and 342 other locations)
Trial IDNCT06356129 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of golcadomide when combined with R-CHOP chemotherapy compared to a placebo combined with R-CHOP in patients with previously untreated high-risk large B-cell lymphoma. Participants will be assessed for their response to treatment based on specific eligibility criteria, including the type of lymphoma and disease characteristics. The study is designed as a Phase 3 interventional trial, indicating a focus on confirming the efficacy and safety of the treatment regimen in a larger patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with previously untreated high-risk large B-cell lymphoma, including specific subtypes and disease characteristics.

Not a fit: Patients with low-risk large B-cell lymphoma or those who have received prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with high-risk large B-cell lymphoma.

How similar studies have performed: Other studies have shown promise in using combination therapies for large B-cell lymphoma, but the specific combination of golcadomide with R-CHOP is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:

i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified \[including germinal center B-cell (GCB) and activated B-cell (ABC) types\]

ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)

iii) High-grade B-cell lymphoma, not otherwise specified

iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)

v) Epstein-Barr virus + DLBCL

* International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) \> 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3.
* Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (\> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
* Must have Ann Arbor Stage II-IV disease.

Exclusion Criteria:

* Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
* Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
* Documented or suspected central nervous system (CNS) involvement by lymphoma.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Mobile, Alabama and 342 other locations

+293 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: Large B-cell Lymphoma, Lymphoma, Large B-Cell, Lymphoma, BMS-986369, CC-99282, DLBCL

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.