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 (GOLSEEK-1)

Celgene

Status and phase: Enrolling; Phase 3

Conditions: Large B-cell Lymphoma

Treatments: Drug: Golcadomide; Drug: Doxorubicin; Drug: Prednisone; Drug: Vincristine; Drug: Placebo; Drug: Rituximab; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06356129

CA073-1020

2023-510178-15 (Registry Identifier)

U1111-1300-8493 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 850 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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850 participants in 2 patient groups, including a placebo group

Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)

Experimental group

Treatment:

Drug: Cyclophosphamide

Drug: Rituximab

Drug: Vincristine

Drug: Prednisone

Drug: Doxorubicin

Drug: Golcadomide

Placebo + R-CHOP

Placebo Comparator group

Treatment:

Drug: Cyclophosphamide

Drug: Rituximab

Drug: Placebo

Drug: Vincristine

Drug: Prednisone

Drug: Doxorubicin