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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

NCT06356129

Active Not RecruitingPhase 3

Sponsor: Celgene

Conditions: Large B-cell Lymphoma

Interventions: Golcadomide, Placebo, Rituximab, Cyclophosphamide, Doxorubicin

Countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (325)

Mobile, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
San Francisco, California, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Margate, Florida, United States
Miami Beach, Florida, United States
Pensacola, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Weston, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Waukee, Iowa, United States
Westwood, Kansas, United States
Edgewood, Kentucky, United States
Baton Rouge, Louisiana, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
Reno, Nevada, United States
East Brunswick, New Jersey, United States
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
New Brunswick, New Jersey, United States
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