Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Large B-cell Lymphoma

In brief

The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).

Key facts

Study ID

NCT06356129

Run by

Celgene

People needed

850

Starts

2024-06-19

Expected to finish

2029-06-26

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Local Institution - 0477 — Anchorage, Alaska, United States
• Local Institution - 0452 — Phoenix, Arizona, United States
• Local Institution - 0342 — San Francisco, California, United States
• Local Institution - 0497 — Fort Myers, Florida, United States
• Local Institution - 0287 — Jacksonville, Florida, United States
• Local Institution - 0415 — Margate, Florida, United States
• Local Institution - 0045 — Miami Beach, Florida, United States
• Local Institution - 0012 — Pensacola, Florida, United States
• Local Institution - 0502 — St. Petersburg, Florida, United States
• Local Institution - 0414 — Tampa, Florida, United States
• Local Institution - 0192 — West Palm Beach, Florida, United States
• Local Institution - 0485 — Weston, Florida, United States
• Local Institution - 0515 — Atlanta, Georgia, United States
• Local Institution - 0303 — Atlanta, Georgia, United States
• Local Institution - 0182 — Chicago, Illinois, United States
• Local Institution - 0048 — Skokie, Illinois, United States
• Local Institution - 0461 — Waukee, Iowa, United States
• Local Institution - 0031 — Westwood, Kansas, United States
• Local Institution - 0436 — Edgewood, Kentucky, United States
• Local Institution - 0408 — Baton Rouge, Louisiana, United States
• Local Institution - 0478 — Ann Arbor, Michigan, United States
• Local Institution - 0067 — Minneapolis, Minnesota, United States
• Local Institution - 0203 — Rochester, Minnesota, United States
• Local Institution - 0437 — Kansas City, Missouri, United States
• Local Institution - 0014 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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