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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

Large B-Cell Lymphoma

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).

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 to 80

Participation 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.

Study Location

St. Marys Hospital Center
St. Marys Hospital Center
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Tanya Skamene, Site 0153

514340822224572
BC Cancer Victoria
BC Cancer Victoria
Victoria, British Columbia
Canada

Contact Study Team

Primary Contact

Jason Hart, Site 0091

250-519-5500
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - Hôpital du Sacré-Coeur
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - Hôpital du Sacré-Coeur
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Ines Chamakhi, Site 0073

5143342222
Local Institution - 0492
Local Institution - 0492
Edmonton, Alberta
Canada

Contact Study Team

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS
Sherbrooke, Quebec
Canada

Contact Study Team

Study Sponsored By
Celgene
Participants Required
More Information
Study ID: NCT06356129